WO2020001174A1 - 连接可靠的植入物推送装置及植入物输送系统 - Google Patents

连接可靠的植入物推送装置及植入物输送系统 Download PDF

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Publication number
WO2020001174A1
WO2020001174A1 PCT/CN2019/086279 CN2019086279W WO2020001174A1 WO 2020001174 A1 WO2020001174 A1 WO 2020001174A1 CN 2019086279 W CN2019086279 W CN 2019086279W WO 2020001174 A1 WO2020001174 A1 WO 2020001174A1
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WO
WIPO (PCT)
Prior art keywords
implant
pushing
steel cable
clamping
inner core
Prior art date
Application number
PCT/CN2019/086279
Other languages
English (en)
French (fr)
Inventor
李阳
张庭超
董壮
Original Assignee
杭州唯强医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 杭州唯强医疗科技有限公司 filed Critical 杭州唯强医疗科技有限公司
Publication of WO2020001174A1 publication Critical patent/WO2020001174A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels

Definitions

  • the invention belongs to the technical field of medical equipment, and relates to an implant pushing device and an implant delivery system with reliable connection.
  • Interventional treatment refers to the placement of various materials and instruments on the human heart, arteries, veins and other blood vessels through catheter technology to treat cardiovascular diseases.
  • VCF vena cava filter
  • the device is delivered to the left atrial appendage to prevent blood clots caused by atrial fibrillation from flowing to the brain, causing stroke or other systemic embolism.
  • the implantation of such devices requires a delivery system to deliver the implant to various parts of the human body, and then release the pushing device from the implant.
  • Existing implant pushing devices include a pushing device and a handle.
  • the distal end of the pushing device can be detachably connected to the implant by means of screw connection or friction.
  • the proximal end of the pushing device is connected to the handle, which is convenient for doctors.
  • the implant is pushed during the operation and the release and release of the implant is controlled.
  • This type of conveying system has certain limitations: for screw-connected conveying systems, the operating handle and pushing device need to be rotated when released, but the operator must operate with both hands, which is inconvenient to operate.
  • the frictional force is constantly changing in the human body's curved blood vessel path. Too much or too little frictional force may cause the implant to become stuck or released in advance, causing surgical failure.
  • Existing implant pushing devices include a pushing device and a handle.
  • the distal end of the pushing device can be detachably connected to the implant by means of screw connection or friction.
  • the proximal end of the pushing device is connected to the handle, which is convenient for doctors.
  • the implant is pushed during the operation and the release and release of the implant is controlled.
  • This type of conveying system has certain limitations: for screw-connected conveying systems, the operating handle and pushing device need to be rotated when released, but the operator must operate with both hands, which is inconvenient to operate.
  • the frictional force is constantly changing in the human body's curved blood vessel path. Too much or too little frictional force may cause the implant to become stuck or released in advance, causing surgical failure.
  • the technical problem to be solved by the present invention is to provide a reliable connection to the implant pushing device and the implant delivery system, which not only has a reliable connection with the implant, and prevents the implant from The implant pushing device released in advance before reaching the designated site, and when the implant is released, the operator does not need to rotate the pushing device, only one-handed operation can release the connection with the implant, and quickly release the implant .
  • An implant pushing device with reliable connection includes a pushing component and a handle component connected to the proximal end of the pushing component.
  • the pushing component is characterized in that the pushing component includes a hollow pushing steel cable and is movably mounted on the pushing.
  • a hook is provided at the distal end of the arm; the planes where at least two of the hooks are located do not coincide;
  • the handle assembly includes a handle, an axial drive control mechanism provided on the handle, and an elastic member connected to the axial drive control mechanism; compression or reset of the elastic member drives the axial drive control mechanism To drive the axial relative movement between the pushing steel cable and the inner core.
  • hook members extend toward or away from the central axis direction of the pushing steel cable, and a plurality of hook members extend in different directions.
  • the clamping member has a free state and a locked state.
  • the clamping arms When the clamping member is in a free state, the clamping arms extend beyond the distal end of the pushing steel cable, and all the distal ends of the clamping arms are respectively Radially spread out in different directions in the radial direction; when the clamping member is in a locked state, all the clamping arms are retracted into the pushing steel cable and retracted toward the central axis of the pushing steel cable, and at least one
  • the hook members are connected or staggered to form a ring-shaped closed structure, or at least two of the hook members are connected or staggered to form a ring-shaped closed structure.
  • an included angle between at least one of the clamping arms and a central axis of the pushing steel cable ranges from 90 ° to 150 ° or 200 ° to 270 °, and two ring-shaped closed structures are formed.
  • the included angle between the clamping arms and the central axis of the pushing steel cable is not equal.
  • the handle is provided with a control slot along the axial direction
  • the axial drive control mechanism includes a slider connected to the pushing steel cable or the inner core, and a connection member connected to the slider,
  • the connecting piece penetrates from the control groove to the outside of the handle, and the connecting piece slides in the axial direction and drives the sliding piece to move, so as to drive the axial relative between the pushing steel cable and the inner core. motion.
  • the sliding member is connected to the pushing steel cable, and the elastic member is connected to a proximal end of the sliding member. Therefore, when the elastic member is compressed, the clamping member is in a free state; when the elastic member is reset, the clamping member is in a locked state.
  • the sliding member is connected to the inner core, and the elastic member is connected to a distal end of the sliding member. Therefore, when the elastic member is compressed, the clamping member is in a free state; when the elastic member is reset, the clamping member is in a locked state.
  • a guide is provided in the handle along the axial direction, and the sliding member moves axially along the guide.
  • a driving limiter is further provided in the handle, and the driving limiter restricts the radial movement of the elastic member.
  • a limiting member is provided at a distal end of the pushing steel cable, the limiting member is provided with a limiting hole along an axial direction of the pushing steel cable, and when the clamping member is in a free state, the hook member and The distal ends of the clamping arms all protrude from the limiting hole.
  • the hook member is located outside the limiting hole and is connected to the proximal end of the hook member. The distal ends of the clamping arms are closed together in the limiting hole.
  • the dimension of the major axis of the limiting hole is larger than the dimension of the outermost side of each of the clamping arms in a locked state on a plane perpendicular to the axial direction of the inner core, and smaller than A size of each of the hook members on a plane perpendicular to the axial direction of the inner core in a locked state of the clamping member; a short axis dimension of the limiting hole is substantially equal to a plurality of proximal ends of the clamping arms The sum of the dimensions of the part on a plane perpendicular to the axial direction of the inner core.
  • the implant pushing device further includes an inner core fixing member, the inner core fixing member includes a stroke portion fixedly connected to the inner core, and an adjustment portion fixedly connected to the handle, and the adjustment portion It is movably connected with the stroke part.
  • An implant delivery system includes the aforementioned implant pushing device, and further includes an outer sheath tube having a certain axial length.
  • the implant pushing device is movably mounted in the outer sheath tube and communicates with the outer sheath tube.
  • the proximal ends of the outer sheaths are detachably connected.
  • the implant delivery system further includes an expansion device, the expansion device is movably inserted into the outer sheath tube, and a proximal end of the expansion device and a proximal end of the outer sheath tube may be Disconnect.
  • the implant delivery system further includes a loading device, and the loading device is detachably connected between the proximal end of the outer sheath tube and the distal end of the pushing device.
  • the implant delivery system further includes a hemostatic device, and the hemostatic device is detachably connected between the loading device and a distal end of the pushing device.
  • At least one of the outer sheath, the loading device, and the hemostatic device is provided with an elastic seal, and the elastic seal is provided with at least one aperture along an axial direction of the pushing device.
  • a first slit is formed at a proximal end of the elastic seal
  • a second slit is formed at a distal end of the elastic seal
  • a sum of thicknesses of the first slit and the second slit is equal to The thickness of the elastic seal
  • the directions of the first slit and the second slit are different
  • the projection of the first slit on the distal surface of the elastic seal is different from that of the second slit in the The projections of the distal surface of the elastic seal intersect.
  • the projection of the first slit on the distal surface of the elastic seal is perpendicular to the projection of the second slit on the distal surface of the elastic seal.
  • the hooks of the implant pushing device are connected or staggered to form a ring-shaped closed structure, which has a reliable connection and locking force with the implant to prevent the implant from being released in advance before reaching the designated site; furthermore, The opening form and the locking force of the clamping member can be adjusted according to different implant types and the requirements of the implant on the connection force of the pushing device, and the application range is wide.
  • the implant delivery system includes a pushing device, an expanding device, a loading device, a hemostatic device, and an outer sheath tube;
  • FIG. 2 is a schematic diagram of an outer sheath tube and an expansion device assembled together in FIG. 1;
  • FIG. 3 is a schematic diagram of the loading device, the hemostatic device, and the pushing device of FIG. 1 assembled together;
  • FIG. 4 is a schematic view of the outer sheath, the loading device, the hemostatic device, and the pushing device of FIG. 1 assembled together;
  • FIG. 5 is a schematic structural diagram of the pushing device in FIG. 1.
  • the pushing device includes a pushing component and a handle component, and the pushing component includes a pushing steel cable, an inner core, and a clamping member;
  • FIG. 6 is a cross-sectional view of the pushing device in FIG. 5 when the clamping member is in a locked state
  • FIG. 7 is a cross-sectional view of the pushing device in FIG. 5 when the clamping member is in a free state;
  • FIG. 8 is an exploded view of the push component in FIG. 5;
  • FIG. 9a and 9b are schematic diagrams of different states of the clamping member in FIG. 8, wherein FIG. 9a is the clamping member in a free state, and FIG. 9b is the clamping member in a locked state;
  • FIG. 10 is a schematic structural diagram of another embodiment of a clamping member
  • 11 and 12 are schematic structural diagrams of the angle between the clamping arms of the clamping member
  • FIG. 13 is a schematic structural diagram of a limiting member in FIG. 8; FIG.
  • FIG. 14 is a schematic diagram of the connection between the clamping member and the implant in FIG. 5; FIG.
  • FIG. 15 is a sectional view of the handle assembly in FIG. 5;
  • FIG. 16 is an exploded view of the handle assembly in FIG. 5;
  • FIG. 17 is a schematic structural diagram of an outer sheath tube in FIG. 1;
  • FIG. 18 is a partial cross-sectional view of the sheath holder in FIG. 17;
  • FIG. 19 is a schematic structural diagram of an elastic seal in FIG. 18;
  • Figure 20 is a sectional view taken along B-B of Figure 19;
  • Fig. 21 is a sectional view taken along C-C in Fig. 19.
  • FIG. 22 is a schematic structural diagram of the expansion device in FIG. 1;
  • FIG. 23 is a schematic structural diagram of the loading device in FIG. 1;
  • FIG. 24 is a schematic structural diagram of the hemostatic device in FIG. 1.
  • proximal end In the field of interventional medicine, the end that is closer to the operator during surgery is usually called the “proximal end”, and the end farther from the operator is called the “distal end”.
  • the implant delivery system 100 is used to deliver the implant 200 to a predetermined position in a patient and release it.
  • the implant 200 includes, but is not limited to, a vascular filter, a vascular stent, a heart valve clamp, a heart defect occluder, a vascular plug, or a lung volume reducing elastomer.
  • the implant 200 is made of a material having a shape memory function, and can be stretched into a line shape and loaded into a hollow tube body when in use.
  • the proximal end of the implant 200 is provided with a connection portion, usually a curved recovery hook or at least one through hole, for forming a detachable connection with the implant delivery system 100.
  • the implant 200 is an inferior vena cava filter
  • a curved recovery hook is provided at the proximal end of the inferior vena cava filter
  • the implant delivery system 100 delivers the inferior vena cava filter to the patient's inferior vena cava and releases it.
  • the implant delivery system 100 includes an implant pushing device 10, an expansion device 20, a loading device 30, a hemostatic device 40, and an outer sheath 50.
  • the distal end of the expansion device 20 penetrates the distal end of the outer sheath 50 to form an expansion assembly.
  • the distal end of the expansion component follows a track established by a guide wire (not shown) to reach a predetermined treatment site in the patient, and then withdraws the expansion device 20 to keep the outer sheath 50 in the body. aisle.
  • the proximal end of the loading device 30 to the distal end of the hemostatic device 40, and then pass the distal end of the implant pushing device 10 out of the hemostatic device 40 and load in order.
  • the device 30 is detachably connected to the proximal connection portion of the implant 200, and then the device 10 is pushed back to the proximal end to receive the implant 200 into the loading device 30.
  • the distal end of the loading device 30 is connected to the proximal end of the outer sheath tube 50.
  • the pushing device 10 is operated to push the implant 200 toward the distal end until the implant 200 is pushed out of the distal end of the outer sheath tube 50. 200 releases the connection with the implant pushing device 10 and returns to the expanded state to complete the release and implantation of the implant 200.
  • the implant pushing device 10 includes a pushing assembly 1000 and a handle assembly 2000 connected to a proximal end of the pushing assembly 1000.
  • the pushing assembly 1000 includes a hollow pushing steel cable 1100, an inner core 1200 movably inserted in the pushing steel cable 1100, and a distance between the inner core 1200 and the implant 200.
  • the clamping member 1300 includes at least two clamping arms 1320, and a hook 1310 is provided at a distal end of the at least one clamping arm 1320.
  • the hook members 1310 extend toward or away from the central axis direction of the push steel cable 1100.
  • a plurality of hook members 1310 extend in different directions, and the planes where at least two hook members 1310 are located do not overlap.
  • the clamping member 1300 has a free state and a locked state.
  • the distal ends of the clamping arms 1320 extend beyond the distal end of the push cable 1100, and the distal ends of all the clamping arms 1320 are radiated and unfolded in different directions in the radial direction.
  • All the clamping arms 1320 retract into the pushing steel cable 1100 and gather toward the central axis of the pushing steel cable 1100, and at least one hook member 1310 is connected or staggered with the clamping arm 1320 to form a ring-shaped closed structure, or at least two The hooks 1310 are connected or staggered to form a ring-shaped closed structure.
  • each hook member 1310 when a hook member 1310 is provided only at a distal end of a clamping arm 1320, the hook member 1310 cooperates with other clamping arms 1320 to form an annular closed structure.
  • each hook member 1310 can cooperate with other clamping arms 1320 to form a ring-shaped closed structure, and each hook member 1310 can also cooperate with other hook members 1310. Form a closed loop structure.
  • the extension of the hook member 1310 toward the central axis direction of the pushing steel cable 1100 means that the end of the hook member 1310 faces the central axis direction of the pushing steel cable 1100.
  • the extension of the hook member 1310 away from the central axis of the pushing steel cable 1100 means the hook member.
  • the end of 1310 pushes the direction of the central axis of the steel cable 1100 back.
  • the contact of the hook members 1310 means that the end faces of at least two hook members 1310 are in contact with and pressed, or the end faces of the hook members 1310 are in contact with and pressed against the end faces of the clamping arms 1320 to form a ring-shaped closed structure; It means that the hooks 1310 cross each other at least at the ends to form a ring-shaped closed structure, or the ends of the hooks 1310 are not in contact but overlap in a radial projection on the same plane, or multiple hooks 1310 have at least one section at the ends contacting side by side to form a loop Like closed structure. Similarly, when a hook member 1310 is provided, the end of the hook member 1310 or the hook member 1310 intersects with the clamping arm 1320 to form a ring-shaped closed structure.
  • the pushing steel cable 1100 is made of a material having a certain flexibility and a supporting force, and its cross section may be a smooth structure such as a circle or a semi-circle, preferably a circle.
  • the flexibility means that the pushing steel cable 1100 can be bent or twisted to a certain degree.
  • the pushing steel cable 1100 is usually made of a biocompatible metal material or a polymer material.
  • the preferred metal materials are: 316 stainless steel, 304 stainless steel, and the polymer materials are: nylon, polyethylene, Pebax.
  • the pushing steel cable 1100 is a hollow pipe body with a smooth inner wall, and is made by twisting three strands of steel wires.
  • a steel wire (not shown in the figure) may be wound on the outside of the multiple strands of steel wire twisted together. It can be understood that, in other embodiments, in order to enhance the smoothness and supportability of the pushing steel cable 1100, the pushing steel cable 1100 is covered with a film or a metal reinforcing tube; the film is made of a biocompatible polymer material Made of, preferably PTFE, e-PTFE or Pebax.
  • the inner core 1200 has a certain length and is softer than the push steel cable 1100.
  • the inner core 1200 is usually a single metal wire (such as a steel wire or a nickel-titanium wire).
  • the inner core 1200 is movably installed in the pushing steel cable 1100, which means that the inner core 1200 and the pushing steel cable 1100 can move relative to each other in the axial direction, and can be relatively rotated between the two.
  • the holder 1300 is disposed at the distal end of the inner core 1200.
  • the clamping member 1300 includes two clamping arms 1320, and the distal ends of the two clamping arms 1320 are provided with hooks 1310, and each of the hooks 1310 extends toward the central axis direction of the pushing steel cable 1100
  • the extension directions of the two hooks 1310 are different, and the planes on which the two hooks 1310 are located do not coincide. Therefore, the two hooks 1310 are staggered to form a ring-shaped closed structure.
  • each clamping arm 1320 is provided with a hook member 1310 extending toward the central axis direction of the pushing steel cable 1100.
  • the ends of all the hook members 1310 are at the central axis position of the pushing steel cable 1100 or near the position. They are connected or staggered to form a ring-shaped closed structure. It can be understood that, in other embodiments, a plurality of hooks 1310 may extend away from the central axis direction of the pushing steel cable 1100. In this structure, at least two clamping arms 1320 are at the proximal end or The middle part is arranged crossly, so that the hook members 1310 can be connected or overlapped.
  • the clamping arm 1320 is selected from at least one of a straight rod structure, a folded rod-shaped structure, or a curved rod-shaped structure.
  • the clamping arm 1320 is a hollow or solid straight rod structure.
  • the distal ends of the clamping arms 1320 are radiated in different directions in a radial direction, that is, the proximal ends of the plurality of clamping arms 1320 are concentrated and the distal ends are scattered. Referring to FIG.
  • an included angle ⁇ between at least one clamping arm 1320 and a central axis of the pushing steel cable 1100 is preferably in a range of 90 ° to 150 ° or 200 ° to 270 °, that is, 90 ° ⁇ ⁇ ⁇ 150 ° or 200 ° ⁇ ⁇ ⁇ 270 °, preferably 100 ° ⁇ ⁇ ⁇ 130 ° or 230 ° ⁇ ⁇ ⁇ 260 °.
  • the clamping member 1300 when the clamping member 1300 is in a free state, there is always a certain opening angle between at least two clamping arms 1320, which will not be completely closed, which is more conducive to the income of the clamping arm 1320 into the push cable 1100, which reduces Contraction force.
  • the included angles ⁇ between the two clamping arms 1320 and the central axis of the pushing steel cable 1100 are 120 ° and 240 °, respectively. That is, the two clamping arms 1320 are symmetrically disposed about the central axis of the pushing steel cable 1100.
  • the clamping member 1300 is subjected to a shaping process so that the clamping arm 1320 is in a deployed state in a free state.
  • the clamping arm 1320 of the clamping member 1300 should be made of an elastic material and undergo a shaping process so that the clamping arm 1320 is open in a free state.
  • the elastic material here refers to a material that can be bent or twisted by an external force and can be restored to its original state, and is preferably a shape memory material such as nickel-titanium alloy, stainless steel, and cobalt-chromium alloy.
  • a hook 1310 is provided at a distal end of the at least one clamping arm 1320.
  • the hook 1310 is one or more short rods extending toward or away from the central axis.
  • the shape of the short rods may be a straight rod structure, a multi-folded rod-like structure with a combination of multiple straight rods, a bifurcated straight rod structure, and a short rod. It can also be a curved rod-like structure.
  • the shapes of the plurality of hooks 1310 may be the same or different.
  • the planes on which the ends of the two hooks 1310 are located do not overlap, and the two are alternately overlapped to form a ring-shaped closed structure.
  • the two hooks 1310 may also be in contact with each other to form a ring-shaped closed structure.
  • the staggered or overlapping of multiple hooks 1310 makes the hook 1310 of the push assembly 1000 and the implant have a reliable connection locking force, preventing the implant from being released in advance before reaching the designated location, and improving the firm connection. And equipment reliability.
  • the hook member 1310 and its holding arm 1320 protrude from the pushing steel cable 1100, and the holding arm 1320 is no longer subject to the pushing steel cable 1100.
  • the inner wall is restricted and restored to a free state. It is deployed outside the pushing steel cable 1100.
  • the ring-shaped closed structure formed by the plurality of hooks 1310 is opened, and the implant 200 and the pushing device 10 are disconnected.
  • the two hooks 1310 are pressed by the pushing steel cable 1100, the two hooks 1310 that are not in the same plane can be overlapped together.
  • the closed clamp 1300 has a smaller outer diameter, which makes the whole instrument Smaller size and better passage in blood vessels.
  • the clamping member 1300 and the inner core 1200 may be integrally formed, or may be separately formed and then fixed together.
  • a clamping connection portion 1330 is provided at the proximal end of the clamping member 1300 for connecting with the inner core 1200.
  • the clamping connection portion 1330 and the clamping arm 1320 may be made of the same material, or may be made of different materials.
  • the clamping connection portion 1330 is a tubular or rod-like structure with a supporting force and is made of a material having a certain rigidity.
  • the clamping connection portion 1330 is preferably made of 316 stainless steel , 304 stainless steel, nickel-titanium alloy or cobalt chromium alloy.
  • the clamping connection portion 1330 and the clamping arm 1320 are made of stainless steel, and the two are integrally formed.
  • the distal end of the pushing steel cable 1100 is provided.
  • the limiting member 1110 is provided with a limiting hole 1111 along the axial direction of the pushing steel cable 1100.
  • a ring-shaped closure formed between the plurality of hook members 1310 The structure is located outside the limiting hole 1111, that is, the hook 1310 is located outside the limiting hole 1111, and the distal end of the clamping arm 1320 connected to the proximal end of the hook 1310 is closed together in the limiting hole 1111.
  • the ring-shaped closed structure when the ring-shaped closed structure is formed between the hook member 1310 and the clamping arm 1320, the ring-shaped closed structure is located outside the limiting hole 1111 means that the hook member 1310 is located in the limiting hole On the outside of 1111, the distal end portion of the clamping arm 1320 that is connected to or staggered with the hook member 1310 to form a ring-shaped closed structure is also located outside the limit hole 1111.
  • the clamping arm 1320 that is connected to the proximal end of the hook member 1310 is limited.
  • the hole 1111 is closed with the proximal end portion of the other clamping arm 1320 in the limiting hole 1111.
  • the cross-section of the limiting hole 1111 is rectangular, oval, or oblate.
  • the size of the long axis of the limiting hole 1111 meets: all clamping arms 1320 are brought together and at least two hooks 1310 are connected or staggered to form a closed loop structure, or at least one hook 1310 is connected to the clamping arm 1320 Staggered to form a ring-shaped closed structure.
  • the limiting holes 1111 restrict the tight overlapping of the multiple clamping arms 1320 that are closed together without radial offset, thereby ensuring that the hooks 1310 connected to the clamping arms 1320 are closely connected or staggered to form a loop. Like closed structure to ensure the effectiveness of the connection.
  • the two clamping arms 1320 of the clamping member 1300 both pass through the limiting hole 1111 on the limiting member 1110.
  • the cross-sectional shape of the limiting hole 1111 is oblate, and can accommodate the two hooks 1310 and the clamping arm 1320 in the locked state.
  • the length of the long axis of the limiting hole 1111 is larger than the size of the outermost side of each clamping arm 1320 in a locked state on the plane perpendicular to the axial direction of the core 1200 in the locked state of the clamping member 1300 and smaller than the clamping member 1300 in the locked state.
  • each hook member 1310 on a plane perpendicular to the axial direction of the inner core 1200 ensures that the clamping arm 1320 can be smoothly folded into the limiting hole 1111 in the locked state, and the hook member 1310 resists the distance of the limiting member 1110.
  • the end will not enter the limiting hole 1111; the short-axis dimension of the limiting hole 1111 is approximately equal to the sum of the dimensions of the proximal ends of the multiple clamping arms 1320 on a plane perpendicular to the axial direction of the core 1200 to ensure that the clamping arms 1320
  • the proximal ends can be closed together in the limiting hole 1111, and the clamping arm 1320 can smoothly extend out of the limiting hole 1111.
  • the two clamping arms 1320 of the clamping member 1300 protrude from the limiting hole 1111, since it is no longer restricted
  • the radial restraint of the position member 1110, the two clamping arms 1320 are radially expanded outward, and the clamping member 1300 is in an open free state; when the inner core 1200 is retracted to the proximal end or the steel cable is pushed to the distal end At 1100, the two clamping arms 1320 of the clamping member 1300 are received in the limiting hole 1111, and the distal ends of the two clamping arms 1320 are radially restricted by the limiting member 1110, and are limited by the limiting member 1110.
  • the bit hole 1111 is squeezed and gathered toward the central axis, forcing the hook member 1310 to overlap and intersect.
  • the hook member 1310 cooperates with the clamping arm 1320 to form a closed loop.
  • the clamping member 1300 is in a closed state and locks the connection with the implant 200.
  • the limiting member 1110 is preferably made of a harder biocompatible material (for example, stainless steel) to ensure that the clamping member 1300 can be overlapped and closed after being pressed by the limiting member 1110.
  • the clamping arm 1320 may also be an arc shape bent away from the central axis, the hook member 1310 is an arc shape whose opening is directed toward the central axis, and at least one central portion of the arc of the clamping arm 1320
  • the included angle ⁇ between the tangent and the clamping connection 1330 ranges from 90 ° to 150 °. This structure is more conducive to reducing the bending stress of the clamping member 1300 and improving the fatigue strength of the clamping member 1300.
  • the connection between the implant pushing device 10 and the implant 200 in this embodiment has a certain flexibility for the following reasons:
  • the pushing assembly 1000 can be The deflection angle C1 ranges from 0 ° to 180 ° in the plane where the proximal end of the implant 200 is located, along the axial direction of the implant 200.
  • the pushing assembly 1000 can also be deflected in a plane perpendicular to the plane where the proximal connection portion of the implant 200 is located, and the deflection angle C2 ranges from 0 ° to 180 °. Therefore, the implant pushing device 10 of this embodiment is at Greater flexibility in curved blood vessels.
  • a core fixing member is provided between the proximal end of the core 1200 and the handle 2100 to adjust the relative position between the core 1200 and the handle 2100.
  • the inner core fixing member includes a stroke portion 1230 fixedly connected to the inner core 1200 and an adjustment portion 2130 fixedly connected to the handle 2100.
  • the adjustment portion 2130 and the stroke portion 1230 are movably connected.
  • a section of a screw is connected to the proximal end of the inner core 1200, and the screw is used as the stroke part 1230.
  • a nut is provided as the adjustment part 2130 in the handle 2100, and the screw is matched with the nut.
  • the operator can adjust the position of the nut on the screw to adjust the relative position between the inner core 1200 and the handle 2100 and the push steel cable 1100 to avoid the inner core 1200. Being excessively pulled or the inner core 1200 is too loose, which affects the locking effect of the clamp 1300.
  • the handle assembly 2000 is disposed on the proximal end of the pushing device 1000 for operating the connection or disconnection between the pushing device 1000 and the implant 200.
  • the handle assembly 2000 includes a handle 2100, an axial drive control mechanism 2300 provided on the handle 2100, and an elastic member 2500 provided on a proximal end of the axial drive control mechanism 2300.
  • the handle 2100 includes a first housing 2110 and a second housing 2120 opposite to each other, and the two are fixedly connected together by means of snaps, adhesives, and the like.
  • a distal end cover 2400 is sleeved at the distal end of the two to limit the distance between the two. Mobile.
  • a control slot 2200 is provided on the handle 2100 along the axial direction.
  • the length of the control slot 2200 is greater than or equal to the maximum relative movement distance between the pushing steel cable 1100 and the inner core 1200, so as to realize the transition between the free state and the locked state of the clamping member 1300.
  • the control slot 2200 can be directly opened on the first housing 2110 or the second housing 2120, or a slot can be formed on each of the first housing 2110 and the second housing 2120 and then fastened together to form the control slot 2200.
  • the axial drive control mechanism 2300 includes a sliding member 2330 connected to the pushing steel cable 1100 or the inner core 1200, and a connecting member 2320 connected to the sliding member 2330.
  • the connecting member 2320 penetrates from the control groove 2200 to the outside of the handle 2100. Sliding axially and driving the slider 2330 to drive the axial relative movement between the pushing steel cable 1100 and the inner core 1200.
  • the sliding member 2330 and the proximal end of the pushing steel cable 1100 are connected by means of screwing, snapping, interference fit, pinning, welding, riveting, etc., which are common in the art, and the inner end of the inner core 1200 is pushed by itself. After the proximal end of the steel cable 1100 is extended, it is fixed in the handle 2100 by the inner core fixing member.
  • the handle 2100 is provided with a guide member to limit the sliding member 2330 to move axially along the guide member to ensure smooth sliding of the sliding member 2330.
  • the guide member may be in the form of a groove, and the sliding member 2330 is slidably fitted in the groove.
  • the guide member may also be in the form of a rod-shaped body.
  • the slider 2330 is threaded on the rod-shaped body and moves axially along the rod-shaped body.
  • the connecting member 2320 is inserted into the control slot 2200 and penetrates from the control slot 2200 to the outside of the handle 2100, which is convenient for an operator to operate.
  • an elastic member 2500 is connected to the proximal end or the distal end of the sliding member 2330, and the axial movement of the axial drive control mechanism 2300 is driven by the compression or reset of the elastic member 2500 to drive the push cable 1100 and Relative axial movement between the inner cores 1200.
  • the elastic member 2500 is connected to the distal end of the slider 2330; when the slider 2330 is connected to the push cable 1100, the elastic member 2500 is connected to the proximal end of the slider 2330.
  • the pushing steel cable 1100 moves to the proximal end, and the clamping member 1300 protrudes from the pushing steel cable 1100.
  • the implant 200 can be connected.
  • the elastic member 2500 is elastic due to its elasticity, After resetting, the pushing steel cable 1100 moves to the far end, the clamping member 1300 retracts into the pushing steel cable 1100, and the hooks 1310 alternately overlap to form a ring-shaped closed structure, locking the connection with the implant 200.
  • the elastic member 2500 has elastic force, the axial driving control mechanism 2300 is pressed by the elastic member 2500, and the clamping member 1300 is always locked, which can avoid accidental disconnection between the push assembly 1000 and the implant 200.
  • the elastic member 2500 is in the form of a spring. It can be understood that, in other embodiments, the elastic member 2500 may also be in other forms such as an elastic rod.
  • a driving stopper 2170 for restricting the radial movement of the elastic member 2500 is provided in the handle 2100 along the axial direction, and may be disposed on a proximal end side or a distal end side of the guide member 2180.
  • a bar-shaped groove is provided in the handle 2100 as a driving limiter, and the elastic member 2500 is received in the bar-shaped groove.
  • the elastic member 2500 can also be sleeved on a rod-shaped body, and the rod-shaped body serves as a driving limiter.
  • the outer sheath 50 is hollow inside to pass the expansion device 20 or push the steel cable 1100.
  • the outer wall of the outer sheath tube 50 has a multi-layer structure, and includes a polytetrafluoroethylene material layer, a stainless steel braided layer, and a polyether block amide layer in this order from the inside to the outside.
  • the Teflon material layer is located in the innermost layer. Due to the extremely low friction coefficient of the material itself, the resistance when pushing the steel cable 1100 and the implant 200 through the outer sheath 50 is small; the Teflon material layer can resist acid Alkali resistance, blood, developing liquid, etc.
  • the polyether block amide layer is located at the outermost layer.
  • the polyether block amide layer has good mechanical elastic properties, chemical stability and thermal stability, so that the outer sheath tube 50 has better bending performance and is not easily damaged.
  • the outer sheath tube 50 also includes at least one side branch, which is used to connect with an external device (not shown in the figure) to input a liquid such as a drug or a contrast agent, and can also prevent air from entering the blood vessel during surgery.
  • a sheath holder 52 is provided at the proximal end of the outer sheath tube 50 to be connected to the expansion device 20 or the loading device 30.
  • the sheath holder 52 is T-shaped or Y-shaped, and here is T-shaped.
  • an elastic seal 521 is provided in the sheath seat 52.
  • the elastic seal 521 is made of an elastic material, and the elastic seal 521 is provided with at least one hole along the axial direction of the pushing device 10 for the passage of the pushing steel cable 1100.
  • the elastic seal 521 is a cylinder, the proximal end of the elastic seal 521 forms an elongated first slit 5211, and the distal end of the elastic seal 521 forms an elongated second slit 5212.
  • the sum of the thicknesses of the first slit 5211 and the second slit 5212 is equal to the thickness of the elastic seal 521, and the thickness here refers to the length in the axial direction of the sheath seat 52.
  • the thickness of the first slit 5211 is the same as the thickness of the second slit 5212, which is equal to half the thickness of the elastic seal 521, that is, the first slit 5211 is located at a half of the proximal end of the elastic seal 521.
  • the second slit 5212 is located at a half of the distal end of the elastic seal 521, and the first slit 5211 and the second slit 5212 do not overlap in the thickness direction.
  • the directions of the first slit 5211 and the second slit 5212 are different.
  • the extending direction of the first slit 5211 is a lateral direction
  • the extending direction of the second slit 5212 is a longitudinal direction.
  • the projections of the first slit 5211 and the second slit 5212 on the distal surface of the elastic seal 521 intersect.
  • the intersection is the center of the circle on the surface of the distal end of the elastic seal 521.
  • the projections of the first slit 5211 and the second slit 5212 on the distal surface of the elastic seal 521 are perpendicular to each other, that is, the two form a cross. Since the two slits on the proximal surface and the distal surface of the elastic seal 521 intersect, the intersection is relatively fragile and can be easily penetrated. This intersection becomes the intervention pipe body such as the push cable 1100 or the expansion device 20. The sole passage of the elastic seal 521.
  • the elastic seal 521 is made of an elastic material, when the interventional tube body is withdrawn, the penetrated elastic seal 521 tends to close again, and there are basically no holes or gaps after closing. Therefore, the elastic seal of this embodiment Piece 521 can achieve the effect of automatic sealing. After inserting the elastic seal 521 of this embodiment into the sheath tube holder 52, after passing the pushing steel cable 1100 through and pulling out the elastic seal member 521 for three consecutive times, after testing, the sealing performance of the sheath tube holder 52 can still reach 1.5 ATM (Standard atmospheric pressure) can effectively prevent blood leakage and ensure air tightness.
  • ATM Standard atmospheric pressure
  • the expansion device 20 mainly includes an expansion tube 21 and an expansion tube base 22.
  • the proximal end of the expansion tube 21 is connected to the distal end of the expansion tube base 22.
  • the material of the expansion tube 21 is polyethylene, and the outer diameter of the expansion tube 21 is slightly It is smaller than the inner diameter of the outer sheath tube 50.
  • the dilatation tube 21 further includes a distal tip 23 that is tapered and has an outer diameter that gradually increases from the distal end to the proximal end. Therefore, when the expansion component composed of the expansion device 20 and the outer sheath tube 50 advances along the guide wire and passes through a narrow blood vessel site, the tip 23 can expand the blood vessel to facilitate the smooth passage of the expansion component.
  • the distal end of the loading device 30 is connected to the proximal end of the outer sheath tube 50 by means of a screw connection or the like.
  • the hollow loading device 30 is used to receive and pass the compressed implant ⁇ 200 ⁇ 200.
  • the hemostatic device 40 is connected to the proximal end of the loading device 30.
  • the hemostatic device 40 is hollow and communicates with the loading device 30.
  • a steel cable 1100 is pushed in through the proximal end of the hemostatic device 40 and out of the distal end of the hemostatic device 40 And connected with the implant 200.
  • An elastic seal 41 is provided in the hemostatic device 40, and the structure of the elastic seal 41 may be a common seal ring or a gasket, or may be the same as the structure of the elastic seal 521 in the sheath holder 52. It can be understood that, in other embodiments, the loading device 30 may also be provided with an elastic seal. At this time, the implant delivery system 100 may not need the hemostatic device 40.
  • the structure of the elastic seal in the loading device 30 may be a seal ring or a gasket, or may be the same as the structure of the elastic seal 521 in the sheath holder 52.
  • the implant delivery system 100 may not include the loading device 30, and the proximal end of the outer sheath tube 50 is directly connected to the distal end of the hemostatic device 40.

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Abstract

一种连接可靠的植入物推送装置（10）及植入物输送系统（100），植入物输送系统（100）包括植入物推送装置（10）、扩张装置（20）、装载装置（30）、止血装置（40）及外鞘管（50）。植入物推送装置（10）包括推送组件（1000）及与推送组件（1000）近端相连的手柄组件（2000），推送组件（1000）包括推送钢缆（1100）、活动穿装在推送钢缆（1100）中的内芯（1200）、及设于内芯（1200）远端并与植入物（200）之间可拆卸连接的夹持件（1300）；手柄组件（2000）包括手柄（2100）、设于手柄（2100）上的轴向驱动控制机构（2300）及与轴向驱动控制机构（2300）相连的弹性件（2500）；弹性件（2500）的压缩或复位带动轴向驱动控制机构（2300）的轴向运动，以驱动推送钢缆（1100）与内芯（1200）之间的轴向相对运动。植入物推送装置（10）与植入物（200）之间连接可靠，防止植入物（200）在到达指定部位前提前解脱，并且只需单手操作即可解脱连接，释放植入物（200）。

Description

连接可靠的植入物推送装置及植入物输送系统 技术领域
本发明属于医疗器械技术领域，涉及连接可靠的植入物推送装置及植入物输送系统。
 背景技术
近年来，介入治疗在临床应用中被广泛应用。介入治疗是指通过导管技术将各种材料、器械等放置到人体的心脏、动脉、静脉血管等部位治疗心血管疾病。例如通过导管介入方法放置腔静脉滤器（简称：VCF）到患者的上、下腔静脉，捕获脱落的血栓，预防该血栓沿腔静脉系统上移到心肺，造成肺动脉栓塞；或者将左心耳封堵器输送至左心耳中，预防由于房颤产生的血栓上行至大脑，造成中风或者其他系统性栓塞。这类器械的植入都需要输送系统将植入物输送到人体各个部位，然后将推送装置与植入物解脱分离。
现有的植入物推送装置包括推送装置和手柄，推送装置的远端能与植入物之间通过螺纹连接或摩擦力等方式可拆卸连接，推送装置的近端与手柄相连，便于医生在手术过程中推送植入物并控制植入物的解脱及释放。此类输送系统都存在一定的局限性：对于螺纹连接的输送系统，释放时需要旋转操作手柄及推送装置，但操作者必须双手进行操作，操作不便。对于靠摩擦力连接的输送系统，在人体弯曲血管路径中，摩擦力在不断变化，可能出现摩擦力过大或者过小，会导致植入物卡死或者提前解脱，造成手术失败。
 技术问题
现有的植入物推送装置包括推送装置和手柄，推送装置的远端能与植入物之间通过螺纹连接或摩擦力等方式可拆卸连接，推送装置的近端与手柄相连，便于医生在手术过程中推送植入物并控制植入物的解脱及释放。此类输送系统都存在一定的局限性：对于螺纹连接的输送系统，释放时需要旋转操作手柄及推送装置，但操作者必须双手进行操作，操作不便。对于靠摩擦力连接的输送系统，在人体弯曲血管路径中，摩擦力在不断变化，可能出现摩擦力过大或者过小，会导致植入物卡死或者提前解脱，造成手术失败。
 技术解决方案
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种连接可靠的植入物推送装置及植入物输送系统，不仅与植入物之间具有可靠连接，防止植入物在到达指定部位前提前解脱的植入物推送装置，并且在植入物解脱时，操作者不必旋转推送装置，只需单手操作即可解脱与植入物之间的连接，快速释放植入物。
本发明解决其技术问题所采用的技术方案是：
一种连接可靠的植入物推送装置，包括推送组件及与所述推送组件近端相连的手柄组件，其特征在于，所述推送组件包括中空的推送钢缆、活动地穿装在所述推送钢缆中的内芯、及设于所述内芯远端并与植入物之间可拆卸连接的夹持件；所述夹持件包括至少两个夹持臂，至少一个所述夹持臂远端设有钩件；至少两个所述钩件所在的平面之间不重合；
所述手柄组件包括手柄、设于所述手柄上的轴向驱动控制机构、及与所述轴向驱动控制机构相连的弹性件；所述弹性件的压缩或复位带动所述轴向驱动控制机构的轴向运动，以驱动所述推送钢缆与所述内芯之间的轴向相对运动。
进一步地，所述钩件朝向所述推送钢缆的中轴线方向延伸或背离所述推送钢缆的中轴线方向延伸，多个所述钩件的延伸方向不同。
进一步地，所述夹持件具有自由状态及锁定状态，所述夹持件为自由状态时，所述夹持臂伸出所述推送钢缆远端，所有的所述夹持臂远端分别沿径向向不同方向辐射展开；所述夹持件为锁定状态时，所有的所述夹持臂向所述推送钢缆中回缩并向所述推送钢缆的中轴线收拢，且至少一个所述钩件与所述夹持臂相接或交错形成环状封闭结构，或者至少两个所述钩件相接或交错形成环状封闭结构。
进一步地，自由状态下，至少一个所述夹持臂与所述推送钢缆的中轴线之间的夹角范围为90°至150°或200°至270°，且形成环状封闭结构的两个所述夹持臂与所述推送钢缆的中轴线之间的夹角不相等。
进一步地，所述手柄上沿轴向设有控制槽，所述轴向驱动控制机构包括与所述推送钢缆或所述内芯连接的滑动件、及与所述滑动件连接的连接件，所述连接件自所述控制槽贯通至所述手柄外，所述连接件沿轴向滑动并带动所述滑动件运动，以驱动所述推送钢缆与所述内芯之间的轴向相对运动。
进一步地，所述滑动件与所述推送钢缆相连，所述弹性件与所述滑动件近端相连。由此，所述弹性件压缩时，所述夹持件为自由状态；所述弹性件复位时，所述夹持件为锁定状态。
进一步地，所述滑动件与所述内芯相连，所述弹性件与所述滑动件远端相连。由此，所述弹性件压缩时，所述夹持件为自由状态；所述弹性件复位时，所述夹持件为锁定状态。
进一步地，所述手柄中沿轴向设有导向件，所述滑动件沿所述导向件轴向运动。
进一步地，所述手柄中还设有驱动限位件，所述驱动限位件限制所述弹性件的径向移动。
进一步地，所述推送钢缆的远端设有限位件，所述限位件沿所述推送钢缆的轴向设有限位孔，所述夹持件为自由状态时，所述钩件及所述夹持臂远端均自所述限位孔中伸出，所述夹持件为锁定状态时，所述钩件位于所述限位孔的外部，与所述钩件近端相连的所述夹持臂远端部在所述限位孔中合拢在一起。
进一步地，所述限位孔的长轴尺寸大于所述夹持件在锁定状态下每个所述夹持臂的最外侧在垂直于所述内芯轴向的平面上的尺寸，且小于所述夹持件在锁定状态下每个所述钩件在垂直于所述内芯轴向的平面上的尺寸；所述限位孔的短轴尺寸大致等于多个所述夹持臂的近端部在垂直于所述内芯轴向的平面上的尺寸之和。
进一步地，所述植入物推送装置还包括内芯固定件，所述内芯固定件包括与所述内芯固定连接的行程部、及与所述手柄固定连接的调节部，所述调节部与所述行程部之间活动连接。
一种植入物输送系统，包括前述的植入物推送装置，还包括具有一定轴向长度的外鞘管，所述植入物推送装置活动地穿装在所述外鞘管中，并与所述外鞘管的近端之间可拆卸连接。
进一步地，所述植入物输送系统还包括扩张装置，所述扩张装置活动地穿装在所述外鞘管中，所述扩张装置的近端与所述外鞘管的近端之间可拆卸连接。
进一步地，所述植入物输送系统还包括装载装置，所述装载装置可拆卸地连接在所述外鞘管近端与所述推送装置远端之间。
进一步地，所述植入物输送系统还包括止血装置，所述止血装置可拆卸地连接在所述装载装置与所述推送装置远端之间。
进一步地，所述外鞘管、所述装载装置及所述止血装置中的至少一个中设有弹性密封件，所述弹性密封件沿所述推送装置的轴向设有至少一个孔隙。
进一步地，所述弹性密封件的近端形成第一狭缝，所述弹性密封件的远端形成第二狭缝，所述第一狭缝和所述第二狭缝的厚度之和等于所述弹性密封件的厚度，所述第一狭缝和第二狭缝的方向相异，所述第一狭缝在所述弹性密封件远端表面的投影与所述第二狭缝在所述弹性密封件远端表面的投影之间相交。
进一步地，所述第一狭缝在所述弹性密封件远端表面的投影与所述第二狭缝在所述弹性密封件远端表面的投影之间垂直。
 有益效果
植入物推送装置的钩件之间相接或交错重叠形成环状封闭结构，与植入物之间具有可靠的连接锁紧力，防止植入物在到达指定部位前提前解脱；再者，可以根据不同的植入物类型和植入物对推送装置连接力的要求，调节夹持件的打开形态和锁紧力的大小，适用范围广。
在释放植入物时，操作者无需旋转推送装置，只需单手操作手柄上的轴向驱动控制机构及弹性件，通过弹性件的压缩或复位带动轴向驱动控制机构的轴向运动，以驱动推送钢缆与内芯之间的轴向相对运动，即可快速释放植入物，操作方便简单。
 附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明其中一个实施例的植入物输送系统的结构示意图，植入物输送系统包括推送装置、扩张装置、装载装置、止血装置及外鞘管；
图2是图1中的外鞘管及扩张装置组装在一起的示意图；
图3是图1中的装载装置、止血装置及推送装置组装在一起的示意图；
图4是图1中的外鞘管、装载装置、止血装置及推送装置组装在一起的示意图；
图5是图1中的推送装置的结构示意图，推送装置包括推送组件及手柄组件，推送组件包括推送钢缆、内芯及夹持件；
图6是图5中的推送装置在夹持件处于锁定状态时的剖视图；
图7是图5中的推送装置在夹持件处于自由状态时的剖视图；
图8是图5中的推送组件的分解图；
图9a及图9b是图8中的夹持件的不同状态示意图，其中，图9a是夹持件位于自由状态，图9b是夹持件位于锁定状态；
图10是夹持件的另一种实施方式的结构示意图；
图11及图12是夹持件的夹持臂之间角度的结构示意图；
图13是图8中的限位件的结构示意图；
图14是图5中的夹持件与植入物之间连接的示意图；
图15是图5中的手柄组件的剖视图；
图16是图5中的手柄组件的分解图；
图17是图1中的外鞘管的结构示意图；
图18是图17中的鞘管座的局部剖视图；
图19是图18中的弹性密封件的结构示意图；
图20是图19沿B-B的剖视图；
图21是图19沿C-C的剖视图。
图22是图1中的扩张装置的结构示意图；
图23是图1中的装载装置的结构示意图；
图24是图1中的止血装置的结构示意图。
 本发明的最佳实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
方位定义：在介入医疗领域，通常将手术过程中，距离操作者较近的一端称为“近端”，距离操作者较远的一端称为“远端”。
请参见图1至图24，本实施例提供的植入物输送系统100，用于将植入物200输送至患者体内的预定位置并释放。植入物200包括但不限于血管滤器、血管支架、心脏瓣膜夹钳、心脏缺损封堵器、血管塞或肺减容弹性体。植入物200由具有形状记忆功能的材料制成，使用时可以拉伸成线条状并被装载至中空管体中。植入物200的近端设有连接部，通常是弯曲的回收钩或者至少一个通孔，用于与植入物输送系统100之间形成可拆卸连接。本实施例中，植入物200为下腔静脉滤器，下腔静脉滤器的近端设有弯曲的回收钩，植入物输送系统100将下腔静脉滤器输送至患者的下腔静脉并释放。
参见图1，植入物输送系统100包括植入物推送装置10、扩张装置20、装载装置30、止血装置40及外鞘管50。参见图2，扩张装置20的远端穿出外鞘管50的远端，形成扩张组件。扩张组件的远端沿着导丝（图中未示出）建立的轨道，到达患者体内的预定治疗部位，然后撤出扩张装置20，保留外鞘管50在体内，如此，建立体外到体内的通道。参见图3，当建立体外到体内的通道后，先将装载装置30的近端与止血装置40的远端相连，其后将植入物推送装置10的远端依次穿出止血装置40及装载装置30后，与植入物200近端的连接部之间可拆卸连接，之后向近端回撤推送装置10以将植入物200收入到装载装置30中。参见图4，装载装置30的远端与外鞘管50的近端连接，操作推送装置10向远端推送植入物200，直至将植入物200推出外鞘管50远端，植入物200解脱与植入物推送装置10之间的连接，并恢复至展开状态，完成植入物200的释放及植入。
参见图5，植入物推送装置10包括推送组件1000及与推送组件1000近端相连的手柄组件2000。参见图6至图8，推送组件1000包括中空的推送钢缆1100、活动地穿装在推送钢缆1100中的内芯1200、及设于内芯1200远端并与植入物200之间可拆卸连接的夹持件1300。夹持件1300包括至少两个夹持臂1320，至少一个夹持臂1320远端设有钩件1310。钩件1310朝向推送钢缆1100的中轴线方向延伸或背离推送钢缆1100的中轴线方向延伸，多个钩件1310的延伸方向不同，且至少两个钩件1310所在的平面之间不重合。参见图9a及图9b，夹持件1300具有自由状态及锁定状态。夹持件1300为自由状态时，夹持臂1320远端伸出推送钢缆1100远端，所有的夹持臂1320远端分别沿径向向不同方向辐射展开；夹持件1300为锁定状态时，所有的夹持臂1320向推送钢缆1100中回缩并向推送钢缆1100的中轴线收拢，且至少一个钩件1310与夹持臂1320相接或交错形成环状封闭结构，或者至少两个钩件1310相接或交错形成环状封闭结构。参见图10，当仅在一个夹持臂1320的远端设置一个钩件1310时，该钩件1310与其他夹持臂1320配合形成环状封闭结构。当在多个夹持臂1320的远端分别设置钩件1310时，每个钩件1310可以与其他夹持臂1320配合形成环状封闭结构，每个钩件1310也可以与其他钩件1310配合形成环状封闭结构。
本发明中，钩件1310朝向推送钢缆1100的中轴线方向延伸是指钩件1310末端朝向推送钢缆1100的中轴线方向，钩件1310背离推送钢缆1100的中轴线方向延伸是指钩件1310末端背向推送钢缆1100的中轴线方向。钩件1310的相接是指至少两个钩件1310的末端端面接触抵压，或者钩件1310的末端端面与夹持臂1320末端端面接触抵压，形成环状封闭结构；钩件 1310的交错是指钩件1310至少在末端相互交叉形成环状封闭结构，或钩件1310末端不接触但在同一个平面上的径向投影重叠，或者多个钩件1310至少在末端有一段并排接触形成环状封闭结构。同样，在设置一个钩件1310时，钩件1310末端或钩件1310与夹持臂1320交错交叉形成环状封闭结构。
再次参见图8，推送钢缆1100由具有一定柔性并且具有支撑力的材料制成，其横截面可以为圆形、半圆形等光滑结构，优选为圆形。此处的柔性指推送钢缆1100可以进行一定程度的弯曲或扭转，推送钢缆1100通常由生物相容性的金属材料或者高分子材料制成。优选的金属材料为：316不锈钢、304不锈钢，高分子材料为：尼龙、聚乙烯、Pebax。本实施例中，推送钢缆1100为内壁光滑的中空管体，由三股钢丝捻制而成。为了加强推送钢缆1100的支撑性，在捻制在一起的多股钢丝的外部还可缠绕钢丝（图中未示出）。可以理解的是，在其他实施例中，为了增强推送钢缆1100的光滑性及支撑性，推送钢缆1100外覆盖有覆膜或金属加强管；覆膜由具有生物相容性的高分子材料制成，优选为PTFE、e-PTFE或者Pebax。
内芯1200具有一定长度，较推送钢缆1100更柔软，内芯1200通常是一根单独的金属丝（如钢丝或镍钛丝）。内芯1200活动地穿装在推送钢缆1100中，是指内芯1200可以和推送钢缆1100沿轴向相对运动，二者之间还可相对转动。
夹持件1300设置在内芯1200远端。本实施例中，夹持件1300包括两个夹持臂1320，且两个夹持臂1320的远端均设有钩件1310，每个钩件1310均朝向推送钢缆1100的中轴线方向延伸，两个钩件1310的延伸方向不同，并且两个钩件1310所在的平面之间不重合，由此，两个钩件1310交错形成环状封闭结构。
夹持臂1320张开后，钩件1310之间留出足够植入物200的连接部进入的空间，夹持臂1320合拢后，两个钩件1310末端靠近，并交错贴合形成环状封闭结构，从而与植入物200的连接部之间相连。可以理解的是，在其他实施例中，还可以设置多个夹持臂1320，以加强环状封闭结构的牢固性，提高连接力。每个夹持臂1320都设有朝向推送钢缆1100的中轴线方向延伸的钩件1310，即夹持臂1320合拢后，所有钩件1310的末端在推送钢缆1100的中轴线位置或附近位置相接或者相互交错，共同合围出一个环状封闭结构。可以理解的是，在其他实施例中，还可以是多个钩件1310均背向推送钢缆1100的中轴线方向延伸，在这种结构中，至少两个夹持臂1320在近端部或中部交叉设置，以使得钩件1310能相接或交错重叠。
当夹持件1300为自由状态时，夹持臂1320选自直杆结构、折线杆状结构或曲线杆状结构中的至少一种。本实施例中，夹持臂1320为空心或实心的直杆结构。
当夹持件1300为自由状态时，夹持臂1320远端分别沿径向向不同方向辐射展开，即多个夹持臂1320的近端集中，远端散开。参见图11，自由状态下，优选至少一个夹持臂1320与推送钢缆1100的中轴线之间的夹角α范围为90°至150°或200°至270°，即，90°≤α≤150°或200°≤α≤270°，优选100°≤α≤130°或230°≤α≤260°。为了形成环状封闭结构，需要保证相邻两个夹持臂1320之间不重叠，即，形成环状封闭结构的两个夹持臂1320与推送钢缆1100的中轴线之间的夹角α不相等。因此，在夹持件1300为自由状态时，至少有两个夹持臂1320之间始终具有一定的张开角度，不会完全闭合，更利于夹持臂1320收入推送钢缆1100中，减小收缩力。本实施例中，两个夹持臂1320与推送钢缆1100的中轴线之间的夹角α分别为120°和240°，即两个夹持臂1320关于推送钢缆1100中轴线对称设置。
夹持件1300通过定型处理，使得夹持臂1320在自由状态下呈展开状态。为了保证夹持臂1320受到推送钢缆1100压迫后可顺利收回，在解除约束后可顺利展开，夹持件1300的夹持臂1320应由弹性材料制成，并通过定型处理，使得夹持臂1320在自由状态下呈张开状态。该处的弹性材料指受到外力可以弯曲或扭转、并能恢复原状的材料，优选为镍钛合金、不锈钢、钴铬合金等形状记忆材料。
至少一个夹持臂1320的远端设有钩件1310。钩件1310是朝向中轴线或背离中轴线延伸的一段或多段短杆，短杆的形状可以是直杆结构、多段直杆组合的折线杆状结构、带有分叉的直杆结构，短杆还可以是曲线杆状结构。多个钩件1310形状可以相同也可以不相同。
本实施例中，两个钩件1310的末端所在平面不重叠，二者交错重叠形成环状封闭结构。在其他实施例中，两个钩件1310还可以是末端端面相接触形成相接的环状封闭结构。多个钩件1310的交错重叠或相接，使得推送组件1000的钩件1310与植入物之间具有可靠的连接锁紧力，防止植入物在到达指定部位前提前解脱，提高了连接牢固度及器械可靠性。解锁时，驱动推送钢缆1100和内芯1200之间沿轴向相对运动，钩件1310及其夹持臂1320自推送钢缆1100中伸出，夹持臂1320不再受推送钢缆1100的内壁限制，恢复自由状态，展开于推送钢缆1100外，多个钩件1310形成的环状封闭结构张开，植入物200与推送装置10之间解脱连接。此外，当两个钩件1310受到推送钢缆1100的压迫时，不在同一个平面的两个钩件1310可以交叠在一起，闭合后的夹持件1300的外径尺寸较小，使得器械整体尺寸较小，在血管中的通过性较好。
同时参见图8、图10及图11，夹持件1300与内芯1200可以是一体成型，也可以分别单独成型后再固定在一起。夹持件1300的近端设有夹持连接部1330用于与内芯1200相连。夹持连接部1330与夹持臂1320可以由相同的材料制成，也可以由不同的材料制成。优选的，为了保证夹持件1300的近端支撑性，夹持连接部1330为具有支撑力的管状或杆状结构，并由具有一定刚性的材料制成，夹持连接部1330优选由316不锈钢、304不锈钢、镍钛合金或钴铬合金制成。本实施例中，夹持连接部1330及夹持臂1320均由不锈钢制成，且二者为一体成型。
同时参见图9a、图9b及图13，为了进一步地限制夹持件1300与推送钢缆1100之间的相对转动，保证夹持件1300始终在同一位置交错重叠闭合，推送钢缆1100远端设有限位件1110，且限位件1110沿推送钢缆1100的轴向设有限位孔1111。夹持件1300为自由状态时，钩件1310及夹持臂1320远端均自限位孔1111中伸出，夹持件1300为锁定状态时，多个钩件1310之间形成的环状封闭结构位于限位孔1111的外部，即：钩件1310位于限位孔1111的外部，与钩件1310近端相连的夹持臂1320远端部在限位孔1111中合拢在一起。可以理解的是，在其他实施例中，当钩件1310与夹持臂1320之间形成环状封闭结构时，环状封闭结构位于限位孔1111的外部是指，钩件1310位于限位孔1111的外部，与钩件1310相接或交错形成环状封闭结构的夹持臂1320的远端部分也位于限位孔1111的外部，与钩件1310近端相连的夹持臂1320收入限位孔1111中，并与其他夹持臂1320的近端部分在限位孔1111中合拢在一起。
限位孔1111的横截面为矩形、椭圆形或扁圆形。限位孔1111的长轴尺寸满足：将所有夹持臂1320合拢在一起并使得至少两个钩件1310相接或交错形成封闭环形结构、或者至少一个钩件1310与夹持臂1320相接或交错形成环状封闭结构。通过限位孔1111限制合拢在一起的多个夹持臂1320之间紧密交叠、不发生径向偏移，从而保证与夹持臂1320相连的钩件1310之间紧密相接或交错形成环状封闭结构，保证连接有效性。
本实施例中，夹持件1300的两个夹持臂1320均从限位件1110上的限位孔1111中穿出。限位孔1111的横截面形状为扁圆形，可容纳锁定状态下的两个钩件1310以及夹持臂1320。限位孔1111的长轴尺寸大于夹持件1300在锁定状态下每个夹持臂1320的最外侧在垂直于内芯1200轴向的平面上的尺寸，且小于夹持件1300在锁定状态下每个钩件1310在垂直于内芯1200轴向的平面上的尺寸，保证在锁定状态下夹持臂1320能够顺利收拢进入限位孔1111，而钩件1310则抵住限位件1110的远端不会进入限位孔1111；限位孔1111的短轴尺寸大致等于多个夹持臂1320的近端部在垂直于内芯1200轴向的平面上的尺寸之和，保证夹持臂1320近端部可以在限位孔1111中合拢在一起，并且夹持臂1320能够顺利伸出限位孔1111。
本实施例中，当向远端推送内芯1200或向近端回撤推送钢缆1100时，夹持件1300的两个夹持臂1320自限位孔1111中伸出，由于不再受限位件1110的径向限制，两个夹持臂1320沿径向向外辐射状展开，夹持件1300处于张开的自由状态；当向近端回撤内芯1200或向远端推送钢缆1100时，夹持件1300的两个夹持臂1320收容至限位孔1111中，两个夹持臂1320远端部受到限位件1110的径向限制，并被限位件1110上的限位孔1111挤压，向中心轴聚拢，迫使钩件1310重叠交错，钩件1310与夹持臂1320配合形成闭环，夹持件1300处于闭合状态，锁定与植入物200之间的连接。
限位件1110优选由较硬质的生物相容性材料（如，不锈钢）制成，以保证夹持件1300受到限位件1110的压迫后可以交叠并闭合。
参见图12，在其他实施例中，夹持臂1320还可以为背向中轴线弯曲的弧形，钩件1310是开口指向中轴线的弧形，且至少有一个夹持臂1320的圆弧中部切线与夹持连接部1330之间的夹角β范围为90°至150°。这种结构更利于减小夹持件1300的弯曲应力，提高夹持件1300的疲劳强度。
参见图14，本实施例的植入物推送装置10与植入物200之间的连接具有一定的柔性，原因如下：当夹持件1300与植入物200之间连接后，推送组件1000可在植入物200的近端连接部所在的平面内沿植入物200的轴向偏转，偏转角度C1的范围为0°至180°。此外，推送组件1000还可在垂直于植入物200的近端连接部所在平面的平面内偏转，偏转角度C2范围为0°至180°，因此，本实施例的植入物推送装置10在弯曲的血管中具有更强的适应性。
参见图15，为了能更好进行锁定，保持最佳的锁定状态，优选内芯1200近端与手柄2100之间设有内芯固定件，用于调整内芯1200与手柄2100之间的相对位置。内芯固定件包括与内芯1200固定连接的行程部1230、及与手柄2100固定连接的调节部2130，调节部2130与行程部1230之间活动连接。本实施例中，内芯1200近端连接一段螺杆，该螺杆作为行程部1230，手柄2100中设置螺母作为调节部2130，螺杆与螺母相适配。由此，在将内芯1200组装在手柄2100中时，操作者可通过调整螺母在螺杆上的位置，以调整内芯1200与手柄2100及推送钢缆1100之间的相对位置，避免内芯1200被过度牵拉或内芯1200太松垮，影响夹持件1300的锁定效果。
一并参见图16，手柄组件2000设置在推送装置1000的近端，用于操作推送装置1000与植入物200之间的连接或解脱。手柄组件2000包括手柄2100、设于手柄2100上的轴向驱动控制机构2300，及设于轴向驱动控制机构2300近端的弹性件2500。
手柄2100包括相对设置的第一外壳2110和第二外壳2120，二者之间通过卡扣、粘接等方式固定连接在一起，二者的远端套设有前端盖2400以限制二者之间的移动。
手柄2100上沿轴向设有控制槽2200。控制槽2200的长度大于或等于推送钢缆1100与内芯1200之间最大相对运动距离，以实现夹持件1300在自由状态和锁定状态之间的转换。控制槽2200可以直接在第一外壳2110或第二外壳2120上开设，也可以在第一外壳2110和第二外壳2120上各开一个槽然后扣合在一起形成控制槽2200。
轴向驱动控制机构2300包括与推送钢缆1100或内芯1200连接的滑动件2330、及与滑动件2330连接的连接件2320，连接件2320自控制槽2200贯通至手柄2100外，连接件2320沿轴向滑动并带动滑动件2330运动，以驱动推送钢缆1100与内芯1200之间的轴向相对运动。
本实施例中，滑动件2330与推送钢缆1100近端之间通过本领域常见的螺接、卡接、过盈配合、销接、焊接、铆接等方式相连，而内芯1200近端自推送钢缆1100近端伸出后通过内芯固定件固定在手柄2100中。
手柄2100内设有导向件，以将滑动件2330限制为沿导向件轴向运动，保证滑动件2330的顺畅滑动。导向件可以是凹槽的形式，滑动件2330滑动配合在凹槽中；导向件也可以是杆状体的形式，滑动件2330穿装在杆状体上，沿杆状体轴向运动。
连接件2320穿装在控制槽2200中并自控制槽2200中贯通至手柄2100外，利于操作者的操作。
再次参见图6及图7，滑动件2330的近端或远端连接有弹性件2500，通过弹性件2500的压缩或复位带动轴向驱动控制机构2300的轴向运动，以驱动推送钢缆1100与内芯1200之间的轴向相对运动。具体地，当滑动件2330与内芯1200相连，弹性件2500与滑动件2330远端相连；当滑动件2330与推送钢缆1100相连，弹性件2500与滑动件2330近端相连。由此，当弹性件2500压缩时，推送钢缆1100向近端移动，夹持件1300从推送钢缆1100中伸出，处于自由状态，可连接植入物200；当弹性件2500由于自身弹性复位后，推送钢缆1100向远端移动，夹持件1300向推送钢缆1100中回缩，钩件1310交错重叠形成环状封闭结构，锁定与植入物200之间的连接。而由于弹性件2500具有弹力，轴向驱动控制机构2300受到弹性件2500的挤压，夹持件1300始终保持锁定状态，可避免推送组件1000与植入物200之间意外解脱连接。只有当操作者操作轴向驱动控制机构2300，克服弹性件2500的弹力，弹性件2500压缩，推送钢缆1100后撤，夹持件1300从推送钢缆1100中伸出，解脱与植入物200之间的连接，操作简便。
本实施例中，弹性件2500采用弹簧的形式，可以理解的是，在其他实施例中，弹性件2500还可以采用弹性杆等其他形式。
手柄2100内沿轴向设有用于限制弹性件2500径向移动的驱动限位件2170，可以设置在导向件2180的近端侧或远端侧。具体地，本实施例中，手柄2100中设置条形槽作为驱动限位件，弹性件2500容纳在条形槽中。可以理解的是，在其他实施例中，弹性件2500也可以套装在杆状体上，该杆状体作为驱动限位件。
参见图17，外鞘管50内部中空，以通过扩张装置20或推送钢缆1100。外鞘管50的管壁为多层结构，由内而外依次包括聚四氟乙烯材质层、不锈钢编织层及聚醚嵌段酰胺层。聚四氟乙烯材质层位于最内层，由于其材质本身摩擦系数极低，推送钢缆1100及植入物200在外鞘管50中通过时的阻力较小；聚四氟乙烯材质层可以抗酸抗碱，血液、显影液体等不会对聚四氟乙烯材质层造成损坏；不锈钢编织层强度较高，从而外鞘管50不容易损坏。聚醚嵌段酰胺层位于最外层，聚醚嵌段酰胺层具有良好的力学弹性性能、化学稳定性和热稳定性，使外鞘管50具有较好的弯曲性能，且不容易损坏。外鞘管50还包括至少一个侧支，用于与外部装置（图未示出）连接以输入药物或造影剂等液体，还可以防止手术过程中空气进入血管中。外鞘管50近端设有鞘管座52以与扩张装置20或装载装置30相连。鞘管座52呈T型或者Y型，在此处为T型。
参见图18，鞘管座52中设有弹性密封件521。弹性密封件521由弹性材料制成，且弹性密封件521沿推送装置10的轴向设有至少一个孔隙，用于推送钢缆1100的通过。
参见图19至图21，弹性密封件521呈圆柱体，弹性密封件521的近端形成长条形的第一狭缝5211，弹性密封件521的远端形成长条形的第二狭缝5212，第一狭缝5211和第二狭缝5212的厚度之和等于弹性密封件521的厚度，在这里的厚度是指鞘管座52的轴向上的长度。在本实施例中，第一狭缝5211的厚度与第二狭缝5212的厚度相同，均等于弹性密封件521厚度的一半，即，第一狭缝5211位于弹性密封件521近端的一半处，第二狭缝5212位于弹性密封件521远端的一半处，且第一狭缝5211和第二狭缝5212在厚度方向上没有重叠。第一狭缝5211和第二狭缝5212的方向相异，在此处第一狭缝5211的延伸方向为横向，第二狭缝5212的延伸方向为纵向。第一狭缝5211和第二狭缝5212在弹性密封件521远端表面的投影相交，在本实施例中相交处为弹性密封件521远端的表面的圆心。优选地，第一狭缝5211和第二狭缝5212在弹性密封件521远端表面的投影相互垂直，也即两者形成十字交叉。由于弹性密封件521近端表面和远端表面的两个狭缝形成交叉，交叉点处比较脆弱，较易被贯穿，此交叉点即成为推送钢缆1100或扩张装置20等介入管体穿过弹性密封件521的唯一通道。由于弹性密封件521由弹性材料制成，当介入管体被撤出后，被贯穿的弹性密封件521倾向于再次闭合，且闭合后基本不存在孔洞或缝隙，因此，本实施例的弹性密封件521可以达到自动密封的效果。将本实施例的弹性密封件521装入鞘管座52中，连续三次将推送钢缆1100穿过并拔出弹性密封件521后，经过测试，鞘管座52的密封性能依然可以达到1.5ATM（标准大气压），可以有效地阻止漏血，保证气密性。
参见图22，扩张装置20主要包括扩张管21和扩张管座22，扩张管21的近端与扩张管座22的远端连接，扩张管21的材料为聚乙烯，扩张管21的外径略小于外鞘管50的内径。扩张管21还包括位于远端的尖端头23，尖端头23呈锥形，外径从远端至近端逐渐增大。由此，当扩张装置20和外鞘管50组成的扩张组件沿着导丝前进，通过狭窄的血管部位时，尖端头23可以对血管进行扩张，方便扩张组件的顺利通过。
参见图23，当建立体外到体内的通道后，将装载装置30的远端通过螺纹连接等方式连接于外鞘管50的近端，中空的装载装置30用于容纳并通过压缩后的植入物200。
参见图24，止血装置40与装载装置30的近端连接，止血装置40中空并与装载装置30连通，推送钢缆1100从止血装置40的近端穿入，从止血装置40的远端穿出并与植入物200之间连接。止血装置40中设有弹性密封件41，该弹性密封件41的结构可以是普通的密封圈、密封垫片，也可以与鞘管座52中弹性密封件521的结构相同。可以理解的是，在其他实施例中，装载装置30中也可以设有弹性密封件，此时，植入物输送系统100可以不需要止血装置40。装载装置30中的弹性密封件的结构可以是密封圈或密封垫片，也可以与鞘管座52中弹性密封件521的结构相同。
可以理解的是，在其他实施例中，植入物输送系统100可以不包括装载装置30，由外鞘管50的近端直接与止血装置40的远端相连。
需要说明的是，本说明书中的各个实施例均采用递进的方式描述，每个实施例重点说明的都是与其它实施例的不同之处，各个实施例之间相同相似的部分互相参见即可。对于装置实施例而言，由于其与方法实施例基本相似，所以描述的比较简单，相关之处参见方法实施例的部分说明即可。
以上所揭露的仅为本发明较佳实施例而已，当然不能以此来限定本发明之权利范围，因此依本发明权利要求所作的等同变化，仍属本发明所涵盖的范围。

Claims (19)

  1. 一种连接可靠的植入物推送装置，包括推送组件及与所述推送组件近端相连的手柄组件，其特征在于，所述推送组件包括中空的推送钢缆、活动地穿装在所述推送钢缆中的内芯、及设于所述内芯远端并与植入物之间可拆卸连接的夹持件；所述夹持件包括至少两个夹持臂，至少一个所述夹持臂远端设有钩件；至少两个所述钩件所在的平面之间不重合；
    所述手柄组件包括手柄、设于所述手柄上的轴向驱动控制机构、及与所述轴向驱动控制机构相连的弹性件；所述弹性件的压缩或复位带动所述轴向驱动控制机构的轴向运动，以驱动所述推送钢缆与所述内芯之间的轴向相对运动。
  2. 根据权利要求1所述的植入物推送装置，其特征在于，所述钩件朝向所述推送钢缆的中轴线方向延伸或背离所述推送钢缆的中轴线方向延伸，多个所述钩件的延伸方向不同。
  3. 根据权利要求1所述的植入物推送装置，其特征在于，所述夹持件具有自由状态及锁定状态，所述夹持件为自由状态时，所述夹持臂远端伸出所述推送钢缆远端，所有的所述夹持臂远端分别沿径向向不同方向辐射展开；所述夹持件为锁定状态时，所有的所述夹持臂向所述推送钢缆中回缩并向所述推送钢缆的中轴线收拢，且至少一个所述钩件与所述夹持臂相接或交错形成环状封闭结构，或者至少两个所述钩件相接或交错形成环状封闭结构。
  4. 根据权利要求3所述的植入物推送装置，其特征在于，自由状态下，至少一个所述夹持臂与所述推送钢缆的中轴线之间的夹角范围为90°至150°或200°至270°，且形成环状封闭结构的两个所述夹持臂与所述推送钢缆的中轴线之间的夹角不相等。
  5. 根据权利要求3所述的植入物推送装置，其特征在于，所述手柄上沿轴向设有控制槽，所述轴向驱动控制机构包括与所述推送钢缆或所述内芯连接的滑动件、及与所述滑动件连接的连接件，所述连接件自所述控制槽贯通至所述手柄外，所述连接件沿轴向滑动并带动所述滑动件运动，以驱动所述推送钢缆与所述内芯之间的轴向相对运动。
  6. 根据权利要求5所述的植入物推送装置，其特征在于，所述滑动件与所述推送钢缆相连，所述弹性件与所述滑动件近端相连。
  7. 根据权利要求5所述的植入物推送装置，其特征在于，所述滑动件与所述内芯相连，所述弹性件与所述滑动件远端相连。
  8. 根据权利要求5所述的植入物推送装置，其特征在于，所述手柄中沿轴向设有导向件，所述滑动件沿所述导向件轴向运动。
  9. 根据权利要求1所述的植入物推送装置，其特征在于，所述手柄中还设有驱动限位件，所述驱动限位件限制所述弹性件的径向移动。
  10. 根据权利要求3所述的植入物推送装置，其特征在于，所述推送钢缆的远端设有限位件，所述限位件沿所述推送钢缆的轴向设有限位孔，所述夹持件为自由状态时，所述钩件及所述夹持臂远端均自所述限位孔中伸出，所述夹持件为锁定状态时，所述钩件位于所述限位孔的外部，与所述钩件近端相连的所述夹持臂远端部在所述限位孔中合拢在一起。
  11. 根据权利要求10所述的植入物推送装置，其特征在于，所述限位孔的长轴尺寸大于所述夹持件在锁定状态下每个所述夹持臂的最外侧在垂直于所述内芯轴向的平面上的尺寸，且小于所述夹持件在锁定状态下每个所述钩件在垂直于所述内芯轴向的平面上的尺寸；所述限位孔的短轴尺寸大致等于多个所述夹持臂的近端部在垂直于所述内芯轴向的平面上的尺寸之和。
  12. 根据权利要求1所述的植入物推送装置，其特征在于，所述植入物推送装置还包括内芯固定件，所述内芯固定件包括与所述内芯固定连接的行程部、及与所述手柄固定连接的调节部，所述调节部与所述行程部之间活动连接。
  13. 一种植入物输送系统，其特征在于，包括权利要求1-12中任一项所述的植入物推送装置，还包括具有一定轴向长度的外鞘管，所述植入物推送装置活动地穿装在所述外鞘管中，并与所述外鞘管的近端之间可拆卸连接。
  14. 根据权利要求13所述的植入物输送系统，其特征在于，所述植入物输送系统还包括扩张装置，所述扩张装置活动地穿装在所述外鞘管中，所述扩张装置的近端与所述外鞘管的近端之间可拆卸连接。
  15. 根据权利要求14所述的植入物输送系统，其特征在于，所述植入物输送系统还包括装载装置，所述装载装置可拆卸地连接在所述外鞘管近端与所述推送装置远端之间。
  16. 根据权利要求15所述的植入物输送系统，其特征在于，所述植入物输送系统还包括止血装置，所述止血装置可拆卸地连接在所述装载装置与所述推送装置远端之间。
  17. 根据权利要求16所述的植入物输送系统，其特征在于，所述外鞘管、所述装载装置及所述止血装置中的至少一个中设有弹性密封件，所述弹性密封件沿所述推送装置的轴向设有至少一个孔隙。
  18. 根据权利要求17所述的植入物输送系统，其特征在于，所述弹性密封件的近端形成第一狭缝，所述弹性密封件的远端形成第二狭缝，所述第一狭缝和所述第二狭缝的厚度之和等于所述弹性密封件的厚度，所述第一狭缝和第二狭缝的方向相异，所述第一狭缝在所述弹性密封件远端表面的投影与所述第二狭缝在所述弹性密封件远端表面的投影之间相交。
  19. 根据权利要求18所述的植入物输送系统，其特征在于，所述第一狭缝在所述弹性密封件远端表面的投影与所述第二狭缝在所述弹性密封件远端表面的投影之间垂直。
PCT/CN2019/086279 2018-06-26 2019-05-09 连接可靠的植入物推送装置及植入物输送系统 WO2020001174A1 (zh)

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