WO2019011214A1 - 封堵器推送装置及输送系统 - Google Patents

封堵器推送装置及输送系统 Download PDF

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Publication number
WO2019011214A1
WO2019011214A1 PCT/CN2018/094995 CN2018094995W WO2019011214A1 WO 2019011214 A1 WO2019011214 A1 WO 2019011214A1 CN 2018094995 W CN2018094995 W CN 2018094995W WO 2019011214 A1 WO2019011214 A1 WO 2019011214A1
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WO
WIPO (PCT)
Prior art keywords
occluder
pushing
base
traction member
adjusting rod
Prior art date
Application number
PCT/CN2018/094995
Other languages
English (en)
French (fr)
Inventor
刘香东
陈贤淼
付明娟
Original Assignee
先健科技(深圳)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 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to EP18832502.1A priority Critical patent/EP3653133B1/en
Priority to US16/629,112 priority patent/US11419591B2/en
Publication of WO2019011214A1 publication Critical patent/WO2019011214A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A61B2017/0053—Loading magazines or sutures into applying tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12095—Threaded connection

Definitions

  • the invention belongs to the technical field of interventional medical devices, and relates to an occluder pushing device and a conveying system including the same.
  • interventional methods for the treatment of cardiovascular disease by catheter technology is currently a common treatment. Specifically, it refers to a treatment method in which various materials, instruments, and the like are interposed by a catheter, and is placed in a heart, an artery, a vein, or the like of a human body to treat a cardiovascular disease.
  • interventional methods are used to place interventional medical devices, such as atrial septal defect (ASD) occluder, ventricular septal defect (VSD) occluder, patent ductus arteriosus (abbreviation: PDA) occluder, egg Open hole closure (referred to as: PFO) occluder, etc., reach the defect site of the heart, seal the defect to treat congenital heart disease.
  • interventional medical devices such as atrial septal defect (ASD) occluder, ventricular septal defect (VSD) occluder, patent ductus arteriosus (abbreviation: PDA) occluder, egg Open hole closure (referred to as: PFO) occluder, etc.
  • the interventional medical device When the interventional medical device is delivered to the bronchus of the human heart, artery, vein, left atrial appendage, and lung by a delivery system, the interventional medical device is usually pushed from a flexible push component to a predetermined site, and then the intervention is disconnected. The connection between the medical device and the push component releases the interventional medical device, and then confirms whether the position of the interventional medical device is appropriate by the contrast or ultrasound, whether the intervention of the medical device is unsatisfactory, and whether the surgical effect is satisfactory.
  • the pushing device in the interventional medical procedure, is prone to release the occluder in advance due to accidental contact, resulting in inaccurate release position, resulting in failure of the operation.
  • the present invention provides an occluder pushing device comprising:
  • a pushing assembly comprising a push tube and a slidable traction member inserted inside the push tube;
  • a handle fixedly connected to the proximal end of the push tube, and a movement component and a locking component are disposed therein;
  • the moving assembly includes a translating mechanism for driving the traction member to move axially within the push tube; and a rotating mechanism for driving the traction member within the push tube Rotating around the axis;
  • the locking assembly is configured to lock a relative position of the traction member and the push tube
  • the rotating mechanism includes a locking structure to lock or release linkage with the traction member.
  • the translation mechanism comprises:
  • the linear guide rail and the balance rail are respectively disposed on the first rotating member and the second rotating member parallel to the rotation axis of the first rotating member;
  • a horizontal drive assembly for driving a proximal end of the traction member to linearly reciprocate along the linear guide and the balance rail.
  • the horizontal drive assembly comprises:
  • a tractor mounting seat is slidably disposed on the linear guide rail and the balance rail, and a proximal end of the traction member is fixed on the traction member mounting seat;
  • Pushing coupled to the tractor mount, and at least partially exposed to the handle to urge the tractor mount to move along the first rail and the balance rail.
  • the rotating mechanism is disposed on an end of the second rotating member away from the first rotating member, and the rotating mechanism further includes:
  • Adjusting rod slidably inserted in the base, in rotation with the second rotating member
  • the locking structure is disposed on the base and the adjusting rod, and the locking structure has a locked state and an unlocked state to respectively restrain and release the degree of freedom of rotation of the adjusting rod in the base;
  • the locking structure can be placed in a locked state or an unlocked state.
  • the surface of the balance rail is provided with a damping rib along the moving direction of the traction member mounting seat, and the traction member mounting seat is provided with a sliding member that is pressed against the damping prism.
  • the pushing axial limit is located on the traction member mount, and the first rotating member and the second rotating member drive the traction member mount through the linear guide and the balance rail Rotating about the axis of rotation of the first rotating member relative to the pushing.
  • the locking structure comprises:
  • Stopping pieces are circumferentially spaced apart on the inner side wall of the base;
  • Stopping teeth are circumferentially spaced apart from the outer side wall of the adjusting rod, and a tooth groove is formed between adjacent stopping teeth;
  • the stopping piece may be engaged in the tooth groove or move the stopping tooth into the annular groove.
  • the traction member mounting seat and the pusher are axially constrained by a circumferentially matching limiting edge and a limiting groove, and the limiting edge and the limiting position
  • the slot is circular in cross-section at the mating to effect rotation of the tractor mount relative to the push.
  • the inner side wall of the base and the outer side wall of the adjusting rod are provided with a latching structure to axially limit the adjusting rod in the base without external force interference.
  • the rotating mechanism further includes:
  • the latching mechanism includes a snap ring and a first card slot, the snap ring extending radially from an inner sidewall of the base and abutting an outer sidewall of the adjusting rod; the first card slot is at the The outer side wall of the adjusting rod is circumferentially opened;
  • the card structure further includes a second card slot, and the second card slot is circumferentially opened on an outer sidewall of the adjusting rod;
  • the stopping tooth is located in the annular groove.
  • the locking assembly comprises:
  • a fixing base fixed in the handle
  • An adjustment structure for adjusting an aperture between the movable member and the mount to lock or release the traction member.
  • the adjustment structure comprises:
  • a sleeve sleeved on the fixed seat and the movable member and a diameter of a minimum inscribed circle of the projection of the sleeve on a cross section perpendicular to the axial direction is smaller than a maximum circumscribed circle of the fixed seat and the movable member diameter of;
  • a locking wheel axially limited to the handle and threadedly coupled to the sleeve;
  • the hub of the lock wheel is at least partially exposed to the handle to rotate the lock wheel to drive the sleeve to move axially, so that the sleeve tightens or releases the mount and the movable member.
  • a tapered blind hole is formed in the sleeve, and the movable member cooperates with the fixing seat to form a circular table, and the circular table is located in the tapered blind hole; the sleeve is away from the cone One end of the opening of the blind hole is screwed to the lock wheel by a screw.
  • the present invention provides an occluder delivery system comprising the occluder push device described above, and
  • the push tube of the pushing device is slidably inserted into the delivery sheath tube;
  • a sheath core is coupled to the proximal end of the delivery sheath for adjusting a bending direction of the delivery sheath such that the push tube pushes the occluder along the delivery sheath to a defect to be sealed.
  • the delivery system further includes a hemostatic valve, and a hollow guiding sheath is detachably coupled between the delivery sheath and the hemostatic valve, and the lumen of the guiding sheath is The delivery sheath and the lumen of the hemostatic valve are in communication.
  • the delivery system further includes a preloader detachably coupled to the distal end of the guiding sheath, the preloader including a horn section and an interface section and coupled to the horn section and The connection segment between interface segments.
  • the occluder pushing device and the conveying system have the beneficial effects that: the occluder pushing device is provided with a locking component for locking the pulling member and the pushing tube in a relative position, and then pulling in the process of pushing the occluding device by the pushing tube
  • the relative position of the piece to the push tube can maintain the state of the occluder, thereby avoiding accidental contact with the push device and resulting in inaccurate release position of the occluder.
  • Figure 1 is a schematic view of the implementation of the occluder delivery system, after the occluder is received by the preloader to the guiding sheath, the proximal end of the delivery sheath is connected to the distal end of the guiding sheath;
  • Figure 2 is a schematic view of the structure of the occluder
  • Figure 3 is a schematic structural view of the occluder pushing device
  • Figure 4 is a schematic view showing the internal structure of the pushing device shown in Figure 3;
  • Figure 5a is a schematic view showing the assembly of the enlarged structure of the circle A in Figure 2 and the circle B in Figure 3;
  • Figure 5b is an enlarged view of the structure of the circle C in Figure 4;
  • Figure 6 is a plan view showing the internal structure of the pushing device shown in Figure 4.
  • Figure 7 is a structural view of the locking assembly shown in Figure 6;
  • Figure 8 is a cross-sectional view of the locking assembly shown in Figure 7;
  • Figure 9 is a structural view of the translation mechanism shown in Figure 6;
  • Figure 10 is a bottom view of the translation mechanism shown in Figure 9;
  • Figure 11 is a structural view of the horizontal drive assembly of the translation mechanism shown in Figure 9;
  • Figure 12 is an exploded structural view of the horizontal drive assembly of the translation mechanism shown in Figure 9;
  • Figure 13 is a schematic view showing the connection of the traction member and the traction member mounting seat
  • Figure 14 is a structural view of the second rotating member
  • Figure 15 is a cross-sectional view of the rotating mechanism in the axial direction
  • Figure 16 is a view showing the structure of the base of the rotating mechanism
  • Figure 17 is a structural view of an adjusting lever of a rotating mechanism
  • Figure 18 is an end elevational view of the adjustment rod shown in Figure 17 adjacent to the second rotating member
  • Figure 19 is a schematic view showing the assembly of the second rotating member, the adjusting rod and the base;
  • Figure 20 is a cross-sectional view taken along line I-I of Figure 19;
  • Figure 21 is a view showing a state in which the adjustment lever is rotatable relative to the base in the axial direction;
  • Figure 22 is a view showing a state in which the axial direction of the adjusting rod is located at the base;
  • Figure 23 is a schematic view showing the structure of the preloader
  • Figure 24 is a state diagram of the occluder when the push device is operated.
  • Figure 25 is an enlarged plan view showing a portion of a circle D of Figure 24;
  • Figure 26 is another state diagram of the occluder when the pushing device is in operation (when the occluder is completely closed);
  • Figure 27 is a schematic view of pulling the push assembly toward the proximal end to cause the occluder to enter the guiding sheath through the preloader;
  • Figure 28 is a schematic view showing the push device passing through the hemostatic valve and guiding the sheath through the delivery sheath to push the occluder when the guiding sheath is connected to the delivery sheath.
  • distal and near end are used as the orientation words, which are the common terms in the field of interventional medical devices, wherein “distal” means one end away from the operator during the operation, “near end” means One end of the operator during the procedure.
  • Axial refers to the direction parallel to the center of the distal end of the medical device and the proximal end; radial, refers to the direction perpendicular to the axial direction.
  • an occluder delivery system includes a push device 20, a delivery sheath 60, and a sheath core 70.
  • the pushing device 20 includes a pushing assembly 22 and a handle 21, and the pushing assembly 22 includes a pushing tube 221 and a slidable traction member 222 inserted inside the pushing tube 221; a movement component and a lockable traction member 222 are provided in the handle 21 and pushed
  • the locking member 214 is in a relative position to the tube 221.
  • the moving assembly includes a translation mechanism 215 for driving the traction member 222 to move axially within the push tube 221 and a rotation mechanism 216 for driving the traction member 222 to rotate about the axis within the push tube 221;
  • the rotating mechanism 216 includes a locking structure to lock or release the linkage with the traction member 222. Further, it is possible to prevent the rotating mechanism 216 from being accidentally touched during operation, and the rotating mechanism 216 drives the pulling member 222 to rotate around the axis in the pushing tube 221, thereby improving the operation accuracy of the pushing device 20.
  • the push tube 221 of the push assembly 22 and the distal end of the traction member 222 are respectively detachably connected to the proximal end and the distal end of the occluder 10, and the translation mechanism 215 controls the relative position of the traction member 222 in the push tube 221
  • the position, and thus the proximal end of the occluder 10 is brought closer to or away from the distal end of the occluder 10 to effect deployment and collapse of the occluder 10.
  • the locking assembly 214 locks the traction member 222 in the relative position of the push tube 221 to avoid accidental contact with the push device 20 causing the traction member 222 to move along the push tube 221 to release the occluder 10 in advance.
  • the delivery sheath 60 is a hollow hose that is adjusted by the sheath core 70 attached to the proximal end of the delivery sheath 60 such that the push tube 221 is along The delivery sheath 60 pushes the occluder 10 to the defect to be blocked.
  • the delivery system further includes a hemostasis valve 50, and a hollow guiding sheath 30 is detachably coupled between the delivery sheath 60 and the hemostatic valve 50, and the lumen of the guiding sheath 30 and the delivery sheath 60 are guided.
  • the inner cavity of the hemostatic valve 50 is in communication.
  • the occlusion device 10 is pushed by the delivery sheath 60.
  • a preloader 40 is detachably coupled to the distal end of the guide sheath 30.
  • the preloader 40 includes a horn section 41 and an interface section 43 and a connecting section 42 connected between the horn section 41 and the interface section 43.
  • the horn section 41 defines an outwardly flared flare to accommodate the occluder 10 within the guide sheath 30 by the traction push assembly 22.
  • the interface segment 43 can be detachably connected to the guiding sheath 30 in a threaded manner or a snap connection to remove the preload after the occluder 10 is received into the guiding sheath 30.
  • the distal end of the delivery sheath 60 is coupled to the distal end of the introducer sheath 30.
  • the occluder 10 includes a mesh disk 11, a baffle film 15, and a seam 16 that sutures the mesh disk 11 to the baffle film 15.
  • the distal end and the proximal end of the occluder 10 are respectively provided with a distal end cap 12 and a proximal end plug 13.
  • the distal head 12 is coupled to the external thread 2221 of the traction member 222 by a locking member 14 having an internal thread 141, and the proximal bolt 13 is provided with an external thread that cooperates with the internal thread 2211 provided at the distal end of the push tube 221. 131. Further, when the occluder 10 is released or recovered, the connection to the occluder 10 can be released or established by simply rotating the push tube 221 and the traction member 222. Of course, it can be understood that, referring to Fig. 25, the proximal bolt 13 is provided with a locking hole 132 through which the locking member 14 passes and is locked. The pulling member 222 is axially moved relative to the pushing tube 221 to urge the locking member 14 to drive the distal end. The closure 12 is brought closer to or away from the proximal plug 13 to effect deployment and collapse of the occluder 10.
  • the internal thread 141 may not be disposed at the proximal end of the locking member 14, and the locking member 14 may also be detachably connected to the traction member 222 by means of a buckle. That is, the connection between the locking member 14 and the traction member 222 may be other connection manners, which are not enumerated here, as long as the detachable connection between the locking member 14 and the traction member 222 can be ensured.
  • the proximal end of the push tube 221 is mounted on the housing of the handle 21 through the fixing member 213, and the handle 21 is assembled for facilitating the assembly of the internal member of the handle 21.
  • the housing is formed by enclosing the cover 212 and the bottom case 211.
  • a corresponding fastener 213 secures the proximal end of the push tube 221 to the bottom housing 211 and allows the traction member 222 to pass from the push tube 221 to connect the proximal end of the traction member 222 to the translation mechanism 215, with the translation mechanism 215
  • the drive moves within the push tube 221.
  • proximal end of the traction member 222 can be locked or released by the locking assembly 214 from the proximal end of the push-out tube 221 to the translation mechanism 215, thereby locking the traction member 222.
  • the locking assembly 214 includes a mount 2141, a movable member 2142, and an adjustment structure for adjusting the aperture 2145 between the movable member 2142 and the mount 2141.
  • the adjustment structure can realize the locking or releasing of the traction member 222 by adjusting the size of the aperture 2145.
  • the adjustment can be performed by clamping the movable member 2142 and the fixing base 2141 in a pressing manner, or can be applied to the movable member 2142.
  • the ring member on the fixing base 2141 is configured to clamp the movable member 2142 and the fixing base 2141 when moving in the axial direction.
  • the adjustment structure will be further described below in terms of tightening.
  • the adjustment structure includes a sleeve 2143 sleeved on the fixed seat 2141 and the movable member 2142 and moves the sleeve 2143 axially relative to the fixed seat 2141 and the movable member 2142.
  • Lock wheel 2144 in some embodiments, the adjustment structure includes a sleeve 2143 sleeved on the fixed seat 2141 and the movable member 2142 and moves the sleeve 2143 axially relative to the fixed seat 2141 and the movable member 2142. Lock wheel 2144.
  • the fixing base 2141 is fixed in the handle 21, and the sleeve 2143 is screwed to the locking wheel 2144.
  • the rotation of the lock wheel 2144 can drive the sleeve 2143 to move axially to tighten or release the fixed seat 2141 and the movable member 2142, thereby achieving the locking of the traction member 222, thereby locking or releasing through the movable member 2142 and the fixed seat 2141.
  • a traction member 222 of the intermediate aperture 2145 is provided in the handle 21, and the sleeve 2143 is screwed to the locking wheel 2144.
  • the diameter of the smallest inscribed circle of the projection of the sleeve 2143 in the cross section perpendicular to the axial direction is smaller than the diameter of the largest circumscribed circle of the fixed seat 2141 and the movable member 2142; thus, the sleeve 2143 can be secured relative to the fixed seat.
  • the fixing seat 2141 and the movable member 2142 can be tightly clamped together to form a clamping force to the pulling member 222.
  • such axial relative movement requires a defined relative axial position of the lock wheel 2144 and the fixed seat 2141.
  • the side edge 21411 of the fixing base 2141 which is radially outwardly defines the fixing seat 2141 axially on the bottom case 212 of the handle 21.
  • the locking wheel 2144 is axially limited to the bottom case 212 of the handle 21.
  • the hub 21441 of the lock wheel 2144 is at least partially exposed to the handle 21.
  • a tapered blind hole 21431 is formed in the sleeve 2143, and the movable member 2142 cooperates with the fixed seat 2141 to form a circular table.
  • the circular table is located in the tapered blind hole 21431; the sleeve 2143 is away from the tapered blind
  • One end 21431b of the opening 21431a of the hole 21431 is screwed to the lock wheel 2144 by a screw 21432.
  • the tapered blind hole 21431 is close to and away from the truncated cone, and the clamping or loosening between the fixed seat 2141 and the movable member 2142 is achieved.
  • the screw drive by the screw 21432 is only for reducing the space occupied by the structure, and it is convenient to set the lock wheel 2144 with a larger diameter to improve the torsion resistance performance.
  • the axial driving of the sleeve 2143 can also be achieved by directly fitting the internal thread of the locking wheel 2144 to the external thread of the outer wall of the sleeve 2143.
  • the translation mechanism 215 includes a first rotating member 2151, a second rotating member 2152, a linear guide 2153, a balance rail 2155, and a horizontal drive assembly 2154.
  • the first rotating member 2151 is provided with a through hole 21541b through which the pulling member 222 is inserted in the axial direction.
  • the second rotating member 2152 is disposed coaxially with the first rotating member 2151; the linear guide 2153 and the balance rail 2155 are disposed on the first rotating member 2151 and the second rotating member 2152, respectively, parallel to the rotational axis of the first rotating member 2151.
  • the proximal end of the traction member 222 is fixed to the horizontal driving assembly 2154 through the through hole 21541b of the first rotating member 2151 to linearly reciprocate along the linear guide 2153 and the balance rail 2155 under the driving of the horizontal driving assembly 2154, thereby
  • the push tube 221 fixed to the handle 21 is axially moved to achieve the folding and unfolding of the occluder 10.
  • the horizontal drive assembly 2154 includes a tractor mount 21541 and a push 21542 coupled to the tractor mount 21541.
  • the tractor mount 21541 is slidably disposed on the linear guide 2153 and the balance rail 2155, and the proximal end of the traction member 222 is fixed to the tractor mount 21541.
  • the push 21542 is at least partially exposed to the handle 21 to urge the tractor mount 21541 to move along the first rail and the balance rail 2155.
  • the traction member 222 can be fixed by the locking wire 21541d which is radially disposed along the traction member mounting seat 21541, or can be fixed to the traction member mounting seat 21541 by welding or the like.
  • the movement direction of the tractor mount 21541 is set on the surface of the balance rail 2155.
  • the damper rib 21551 is provided with a sliding member 21545 which is elastically opposed to the damper rib 21551.
  • the damping rib 21551 on the surface of the balance rail 2155 is blocked, so that the occluder 10 can be slowly released during the operation, thereby reducing the adverse effects caused by the excessive pushing. .
  • the sliding member 21545 is elastically opposed to the damping rib 21551.
  • the elastic member 21544 may be disposed at one end of the sliding member 21545 away from the damping rib 21551 to press the sliding member 21545 toward the damping rib 21551. It can be understood that in order to reduce the wear of the sliding process or to avoid the blockage feeling being too strong to push the tractor mount 21541, the slider 21545 is curved at the abutment with the damping rib 21551.
  • the tractor mount 21541 starts to have a through hole 21541b communicating with the side of the damper rib 21551 in the radial direction to provide a mounting space for the elastic member 21544 and the slider 21545.
  • the elastic member 21544 is a spring 2166
  • the sliding member 21545 is a ball
  • the bottom of the spring 2166 is pressed against the ball to abut the ball and the damping rib 21551
  • the top of the spring 2166 is radially restrained along the tractor mounting seat 21541 by the locking member 21543.
  • the locking member 21543 is a grub screw mounted on one side of the through hole 21541b. Accordingly, a threaded hole 21541a is formed in the traction member mounting seat 21541 to cooperate with the flat head screw to lock the lower pressing spring 2166.
  • the push 21542 is axially constrained on the tractor mount 21541, and the first rotor 2151 and the second rotor 2152 are driven relative to the pusher mount 21541 via the linear guide 2153 and the balance rail 2155.
  • the 21542 rotates about the rotational axis of the first rotating member 2151.
  • the tractor mounting seat 21541 drives the traction member 222 to rotate axially within the push tube 221 to achieve connection and separation with the locking member 14 of the occluder 10.
  • the limiting member rib 21541c and the limiting slot 21542c are mutually engaged between the traction member mounting seat 21541 and the pushing 21542, and the limiting edge 21541c is matched with the limiting slot 21542c.
  • the cross section is circular to effect rotation of the tractor mount 21541 relative to the push 21542. It can be understood that the limiting edge 21541c can be disposed on the traction member mount 21541 or on the push 21542.
  • the pushing 21542 is provided with a limiting slot 21542c that cooperates with the limiting edge 21541c; when the limiting edge 21541c is disposed on the pushing 21542, the traction member 222 is disposed.
  • a limiting slot 21542c is provided to cooperate with the limiting edge 21541c.
  • the traction member mounting seat 21541 and the pushing 21542 are respectively provided with matching limiting edges 21541c and limiting slots 21542c.
  • the pushing 21542 includes the pushing base 21542a and the pushing.
  • a cover 21542b is formed to facilitate the assembly of the push 21542 on the tractor mount 21541.
  • a rotating mechanism 216 is provided on an end of the second rotor 2152 remote from the first rotor 2151. The rotating mechanism 216 is rotated to drive the second rotating member 2152 to rotate, and then the traction member mounting seat 21541 is rotated about the axial direction by the linear guide 2153 and the balance rail 2155.
  • the rotating mechanism 216 includes a base 2161 and an adjustment rod 2162.
  • the base 2161 is a hollow cylinder fixed to the casing of the handle 21; the adjusting rod 2162 is slidably inserted into the base 2161 and is rotationally coupled with the second rotating member 2152.
  • the adjusting lever 2162 is rotated in the base 2161, and the second rotating member 2152 can be rotated in conjunction with the rotation. It can be understood that, referring to FIG. 14 and FIG. 18 to FIG.
  • the second rotating member 2152 is inserted into the slot 21265 extending axially along the adjusting rod 2162 through the rotating shaft control rod 2156, and the cross section perpendicular to the axis is non-
  • the circular shape, that is, the slot 21625 allows the rotary shaft control lever 2156 to move in the axial direction to limit only the rotational freedom of the rotary shaft control lever 2156 to achieve rotational linkage about the axial direction.
  • the locking structure is disposed on the base 2161 and the adjustment rod 2162, the locking structure has a locked state and an unlocked state; the locked state and the unlocked state respectively restrain and release the rotation freedom of the adjustment rod 2162 in the base 2161
  • the axial position adjustment of the relative position of the adjustment rod 2162 and the base 2161 can place the locking structure in a locked state or an unlocked state. Therefore, the pushing device 20 prevents the second rotating member 2152 from rotating due to the accidental contact with the adjusting rod 2162 during the pushing of the occluder 10, so that the distal end of the pulling member 222 fixedly connected with the pulling member mounting seat 21541 is disengaged and blocked.
  • the pinning between the locking members 21543 of the device 10 affects the release of the occluder 10.
  • the locking structure includes a stop piece 21612 and a stop tooth 21621 and an annular groove 21611.
  • the stop pieces 21612 are circumferentially spaced around the inner side wall of the base 2161; the stop teeth 21621 are circumferentially spaced around the outer side wall of the adjustment rod 2162, and a tooth groove 21622 is formed between the adjacent stop teeth 21621.
  • the annular groove 21611 is circumferentially opened around the inner side wall of the susceptor 2161. When the adjustment lever 2162 is rotated within the base 2161, the stop tooth 21621 can rotate within the annular groove 21611.
  • the stopping piece 21612 can be engaged in the tooth groove 21622 or the stopping tooth 21621 can be moved into the annular groove 21611.
  • the degree of freedom of rotation between the adjusting rod 2162 and the base 2161 is restricted, even if the adjusting rod 2162 is accidentally touched, the adjusting rod 2162 is also adjusted. It does not rotate around the axial direction, thereby avoiding accidental contact with the pushing device 20 and causing the traction member 222 to rotate away from the connection with the occluder 10, ensuring the accuracy of the occluder 10 release.
  • the inner side wall of the base 2161 and the outer side wall of the adjusting rod 2162 are provided with a latching structure to axially limit the adjusting rod 2162 within the base 2161 without external force interference. Further, the adjusting lever 2162 and the base 2161 are maintained in a locked or released state of rotational freedom, and the locking lever 2162 is prevented from being unlocked by the rotational degree of rotation of the base 2161 due to an accidental touch during operation.
  • the rotating mechanism 216 further includes a screw cap 2164 , a spring seat 2165 , and a spring 2166 that is biased between the spring seat 2165 and the cap 2164 .
  • the screw cap 2164 is fixed to one end of the adjusting rod 2162 away from the second rotating member 2152; the spring seat 2165 is sleeved on the base 2161.
  • the screw cap 2164 can be fixedly connected to the adjusting rod 2162 by the fastening screw 2163, and can also be fixed by a connection such as a buckle.
  • the latching mechanism includes a snap ring 21613 and a first latching groove 21623.
  • the snap ring 21613 extends radially from the inner sidewall of the base 2161 and abuts against the outer sidewall of the adjusting rod 2162;
  • the first card slot 21623 is circumferentially opened on the outer side wall of the adjusting rod 2162; when the snap ring 21613 is engaged with the first card slot 21623, the stopping piece 21612 is engaged in the slot 21622.
  • the adjustment rod 2162 is axially held with the base 2161 in a state in which the rotational freedom is locked, that is, the adjustment rod 2162 cannot be rotated relative to the base 2161 to avoid accidental contact.
  • the traction member 222 is caused to rotate.
  • the spring groove of the spring 2166 drives the retaining groove on the adjusting rod 2162 to be disengaged from the stopping piece 21612 and is located in the annular groove 21611, so that the screw cap can be rotated 2164 rotates the traction member 222 to release the occluder 10 from the connection or to establish a connection for recovery.
  • the card structure further includes a second card slot 21624.
  • the second card slot 21624 is circumferentially opened on the outer sidewall of the adjusting rod 2162.
  • the stop tooth 21621 is located within the annular groove 21611.
  • the cooperation of the second card slot 21624 and the snap ring 21613 can maintain the adjustment lever 2162 and the base 2161 in a release state of rotational freedom, so as to prevent the rotation of the adjustment rod 2162 from being released when the spring 2166 fails.
  • the safety of the operation is improved to ensure that the pusher 20 does not cause the traction member 222 to rotate out of the occluder 10 due to accidental contact.
  • the push assembly 22 coupled to the handle 21 sequentially passes through the hemostasis valve 50, the guiding sheath 30 and the preloader 40, and pushes the assembly 22
  • Push tube 221 and traction member 222 are coupled to proximal plug 13 and lock 14 of occluder 10, respectively.
  • the pusher 21542 on the handle 21 can be moved distally to control the distal movement of the traction member 222 along the push tube 221, so that the locking member 21543 drives the distal end 12 away from the proximal plug 13 to the occluder. 10 is stretched in the axial direction.
  • the occluder 10 is held in a collapsed state.
  • the occluder 10 can be inserted into the introducer sheath 30 via the preloader 40 by pulling the push assembly 22 proximally.
  • the preloader 40 is removed from the guide sheath 30 and the distal end of the guide sheath 30 is coupled to the proximal end of the delivery sheath 60 to complete the operation of the load occluder 10 of the occluder delivery system.
  • the occluder 10 is pushed through the delivery sheath 60 by an occluder delivery system to a predetermined position for deployment and release of the occluder 10.
  • the pushing device 20 controls the movement of the traction member 222 in the pushing tube 221 to be reversible, that is, after the locking member 214 is locked to the pulling member 222, the pushing 21542 is pushed toward the proximal end to cause the pulling member 222 to drive.
  • the lock wire 21541d is adjacent to the proximal plug 13 connected to the distal end of the push tube 221, so that the occluder 10 can be adjusted from the collapsed state to the deployed state.
  • the traction member mounting seat 21541 has a retarding sensation with the damping rib 21551 on the surface of the balance rail 2155 when sliding in the axial direction, so that the sealing can be slowly released during the operation.
  • the plug 10 is 10, thereby reducing the adverse effects caused by pushing too fast.

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Abstract

本发明涉及一种封堵器推送装置及封堵器输送系统，该推送装置包括推送组件和手柄。推送组件包括推送管以及可滑动的插入在推送管内部的牵引件。手柄与推送管的近端固定连接，内设有运动组件以及锁定组件；运动组件包括平移机构和旋转机构；其中，平移机构用于驱动牵引件在推送管内沿轴向运动；旋转机构用于驱动牵引件在推送管内绕轴线转动；锁定组件用于锁定牵引件与推送管的相对位置；旋转机构包括锁止结构以锁定或释放与牵引件之间的联动。本发明推送装置内设有将牵引件和推送管锁定在相对位置的锁定组件，进而在推送管推送封堵器的过程中，牵引件与推送管的相对位置将封堵器锁定在收拢的状态，从而避免封堵器未到达预定位置就提前释放。

Description

封堵器推送装置及输送系统 技术领域
本发明属于介入医疗器械技术领域，涉及一种封堵器推送装置以及包括该推送装置的输送系统。
背景技术
通过导管技术利用介入的方法进行治疗心血管疾病是目前常用的治疗方法。具体是指将各种材料、器械等通过导管介入的治疗方法放置到人体的心脏、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介入医疗器械，如：房间隔缺损(简称：ASD)封堵器、室间隔缺损(简称：VSD)封堵器、动脉导管未闭(简称：PDA)封堵器、卵圆孔未闭(简称：PFO)封堵器等，到达心脏的缺损部位，封堵缺损以治疗先天性心脏病。
在通过输送系统将上述介入医疗器械输送到人体的心脏、动脉、静脉血管、左心耳、肺部的支气管中时，通常将介入医疗器械由柔性的推送组件推送到预定的部位，然后断开介入医疗器械和推送组件的连接，释放介入医疗器械，再通过造影或超声确认介入医疗器械释放位置是否合适、介入医疗器械展开是否不良、手术效果是否满意。
现有技术中，在行介入医疗术中，推送装置容易因误触而提前释放封堵器，导致释放位置不准确，致使手术失败。
发明内容
基于此，有必要针目前封堵器推送装置容易因误触而导致释放位置不准确的问题，提供一种封堵器推送装置及输送系统。
一方面，本发明提供了一种封堵器推送装置，包括：
推送组件，包括推送管以及可滑动的插入在所述推送管内部的牵引件；
手柄，与所述推送管的近端固定连接，内设有运动组件以及锁定组件；
所述运动组件包括平移机构和旋转机构；其中，所述平移机构用于驱动所述牵引件在所述推送管内沿轴向运动；所述旋转机构用于驱动所述牵引件在所述推送管内绕轴线转动；
所述锁定组件用于锁定所述牵引件与所述推送管的相对位置；
所述旋转机构包括锁止结构以锁定或释放与所述牵引件之间的联动。
在其中一个实施方式中，所述平移机构包括：
第一转动件，沿轴向开设供所述牵引件贯穿的通孔；
第二转动件，与所述第一转动件同轴设置；
直线导轨和平衡滑轨，分别平行于所述第一转动件的转动轴线设置于所述第一转动件和第二转动件上；
水平驱动组件，用于驱动所述牵引件的近端沿所述直线导轨和平衡滑轨作直线往复运动。
在其中一个实施方式中，所述水平驱动组件包括：
牵引件安装座，滑设于所述直线导轨和平衡滑轨上，所述牵引件的近端固定于所述牵引件安装座上；
推制，与所述牵引件安装座相连，且至少部分露出于所述手柄，以推动所述牵引件安装座沿所述第一导轨和平衡滑轨运动。
在其中一个实施方式中，所述旋转机构设于所述第二转动件上远离所述第一转动件的一端，所述旋转机构还包括：
基座，中空的筒体，固定于所述手柄的壳体上；
调节杆；可滑动的插入在所述基座内，与所述第二转动件旋转联动；
所述锁止结构设于所述基座与所述调节杆上，所述锁止结构具有锁定状态和解锁状态以分别约束和释放所述调节杆在所述基座内的旋转自由度；
沿轴向调节所述调节杆与所述基座的相对位置，可将锁止结构置于锁定状态或解锁状态。
在其中一个实施方式中，所述平衡滑轨的表面上沿所述牵引件安装座的运动方向设有阻尼棱，所述牵引件安装座内设有与所述阻尼棱弹压相抵的滑动件。
在其中一个实施方式中，所述推制轴向限位于所述牵引件安装座上，所述 第一转动件和第二转动件通过所述直线导轨和平衡滑轨传动所述牵引件安装座相对于所述推制绕所述第一转动件的转动轴线旋转。
在其中一个实施方式中，所述锁止结构包括：
止动片，于所述基座的内侧壁周向间隔设置；
止动齿，于所述调节杆的外侧壁绕周向间隔设置，相邻止动齿之间形成齿槽；
环形槽，绕所述基座的内侧壁周向开设，且所述调节杆在所述基座内旋转时，所述止动齿在所述环形槽内转动；
沿轴向调节所述调节杆与所述基座的相对位置，可将所述止动片卡接于所述齿槽内或将所述止动齿移动至所述环形槽内。
在其中一个实施方式中，所述牵引件安装座与所述推制之间通过周向上相互配合的限位棱和限位槽实现轴向限位，且所述限位棱与所述限位槽在配合处的横截面为圆形，以实现所述牵引件安装座相对于所述推制旋转。
在其中一个实施方式中，所述基座的内侧壁与所述调节杆的外侧壁上设有卡位结构，以使所述调节杆在无外力干涉下轴向限位于所述基座内。
在其中一个实施方式中，所述旋转机构还包括：
旋盖，固定于所述调节杆远离所述第二转动件的一端；
弹簧座，套设于所述基座上；
弹簧，弹压于所述弹簧座与所述旋盖之间；
所述卡位机构包括卡环和第一卡槽，所述卡环从所述基座的内侧壁沿径向延伸并与所述调节杆的外侧壁相抵接；所述第一卡槽于所述调节杆的外侧壁绕周向开设；
所述卡环与所述第一卡槽卡扣时，所述止动片卡接于所述齿槽内。
在其中一个实施方式中，所述卡位结构还包括第二卡槽，所述第二卡槽于所述调节杆的外侧壁绕周向开设；
所述卡环与所述第二卡槽卡扣时，所述止动齿位于所述环形槽内。
在其中一个实施方式中，所述锁定组件包括：
固定座；固定于所述手柄内；
活动件，与所述固定座之间形成供所述牵引件穿过的孔隙；
调节结构，用于调节所述活动件与所述固定座之间的孔隙，以锁定或释放所述牵引件。
在其中一个实施方式中，所述调节结构包括：
套筒，套设于所述固定座和活动件上，且所述套筒在垂直于轴向的横截面上的投影的最小内切圆的直径小于所述固定座和活动件的最大外接圆的直径；
锁轮，轴向限位于所述手柄内，与所述套筒螺纹连接；
所述锁轮的轮毂至少部分露出于所述手柄，以旋转所述锁轮螺纹传动所述套筒沿轴向运动，而使所述套筒紧箍或释放所述固定座和活动件。
在其中一个实施方式中，所述套筒内形成有锥形盲孔，所述活动件与所述固定座配合形成圆台，所述圆台位于所述锥形盲孔内；所述套筒远离锥形盲孔的开口的一端通过螺杆与所述锁轮螺纹连接。
相应的，另一方面，本发明提供了一种封堵器输送系统，包括上述的封堵器推送装置，以及
输送鞘管，为中空的软管；所述推送装置的推送管可滑动的插入至所述输送鞘管内；
鞘芯，连接于所述输送鞘管的近端，用于调节输送鞘管的弯曲方向，以使所述推送管沿所述输送鞘管将封堵器推送至待封堵的缺损处。
在其中一个实施方式中，所述输送系统还包括止血阀，所述输送鞘管与所述止血阀之间可拆卸地连接有中空的导引鞘管，所述导引鞘管的内腔与所述输送鞘管及所述止血阀的内腔相连通。
在其中一个实施方式中，所述输送系统还包括与所述导引鞘管的远端可拆卸连接的预装载器，所述预装载器包括喇叭段和接口段以及连接于喇叭段与接口段之间的连接段。
上述封堵器推送装置及输送系统具有的有益效果为：封堵器推送装置内设有将牵引件和推送管锁定在相对位置的锁定组件，进而在推送管推送封堵器的过程中，牵引件与推送管的相对位置可以保持封堵器的状态，从而避免误触推送装置而导致封堵器释放位置不准确。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的在一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他实施例的附图。
图1为封堵器输送系统实施示意图，将封堵器经预装载器收容至导引鞘管后，将输送鞘管的近端接至导引鞘管的远端；
图2为封堵器结构示意图；
图3为封堵器推送装置结构示意图；
图4为图3示出的推送装置内部结构示意图；
图5a为图2中圆圈A以及图3中圆圈B部分的放大结构装配示意图；
图5b为图4中圆圈C部分的结构放大图；
图6为图4示出的推送装置内部结构俯视图；
图7为图6示出的锁定组件结构图；
图8为图7示出的锁定组件剖面图；
图9为图6示出的平移机构结构图；
图10为图9示出的平移机构仰视图；
图11为图9示出的平移机构的水平驱动组件结构图；
图12为图9示出的平移机构的水平驱动组件分解结构图；
图13为牵引件与牵引件安装座连接示意图；
图14为第二转动件结构图；
图15为旋转机构沿轴向的剖面图；
图16为旋转机构的基座结构图；
图17为旋转机构的调节杆结构图；
图18为图17示出的调节杆靠近第二转动件的端面图；
图19为第二转动件、调节杆以及基座装配示意图；
图20为图19中沿I-I剖面线的剖面图；
图21为调节杆可绕轴向相对于基座旋转时的状态图；
图22为调节杆轴向限位于基座时的状态图；
图23为预装载器结构示意图；
图24为推送装置操作时封堵器状态图；
图25为图24圆圈D部分的结构放大图；
图26为推送装置操作时封堵器另一状态图(封堵器完全收拢时)；
图27向近端拉动推送组件使封堵器经预装载器进入导引鞘管示意图；
图28为导引鞘管与输送鞘管连接时，推送装置穿过止血阀、导引鞘管经输送鞘管推送出封堵器示意图。
具体实施方式
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳实施方式。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施方式。相反地，提供这些实施方式的目的是使对本发明的公开内容理解的更加透彻全面。
需要说明的是，采用“远端”、“近端”作为方位词，该方位词为介入医疗器械领域惯用术语，其中“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。轴向，指平行于医疗器械远端中心和近端中心连线的方向；径向，指垂直于上述轴向的方向。
同时参阅图1至4以及图5a，一种封堵器输送系统，包括推送装置20、输送鞘管60、鞘芯70。其中，推送装置20包括推送组件22和手柄21，推送组件22包括推送管221以及可滑动的插入在推送管221内部的牵引件222；手柄21内设有运动组件以及可锁定牵引件222与推送管221相对位置的锁定组件214。运动组件包括平移机构215和旋转机构216，平移机构215用于驱动牵引件222在推送管221内沿轴向运动；旋转机构216用于驱动牵引件222在推送管221内绕轴线转动；所述旋转机构216包括锁止结构以锁定或释放与牵引件222之间的联动。进而可以防止操作时误触旋转机构216而造成旋转机构216带动牵引件222在推送管221内绕轴线转动，从而提高推送装置20的操作准确性。
具体的，推送组件22的推送管221和牵引件222的远端分别可拆卸的连接在封堵器10的近端和远端上，平移机构215通过控制牵引件222在推送管221内的相对位置，进而使封堵器10的近端靠近或远离封堵器10的远端，实现封堵器10的展开与收拢。锁定组件214将牵引件222锁定于推送管221的相对位置，以避免误触推送装置20引起牵引件222沿推送管221运动而提前释放封堵器10。
当然，可以理解的，在一些实施方式中，输送鞘管60为中空的软管，通过连接在输送鞘管60近端的鞘芯70调节输送鞘管60的弯曲方向，以使推送管221沿输送鞘管60将封堵器10推送至待封堵的缺损处。
在一些实施方式中，输送系统还包括止血阀50，输送鞘管60与止血阀50之间可拆卸地连接有中空的导引鞘管30，导引鞘管30的内腔与输送鞘管60及止血阀50的内腔相连通。以便预先将收拢的封堵器10收纳入导引鞘管30后，再由输送鞘管60进行封堵器10的推送。
同时参阅图1和图24，在一些实施方式中，在导引鞘管30的远端可拆卸连接有预装载器40。参阅图23，预装载器40包括喇叭段41和接口段43以及连接于喇叭段41与接口段43之间的连接段42。喇叭段41向外形成开口较大的喇叭口，以便通过牵引推送组件22将封堵器10收容到导引鞘管30内。可以理解的，接口段43与导引鞘管30可拆卸连接的方式可以是螺纹配合，也可以是卡扣连接，以便在封堵器10收容至导引鞘管30后，取下预装载器40并将输送鞘管60的近端连接在导引鞘管30的远端。
同时参阅图2、3和图5a，在一些实施方式中，封堵器10包括网盘11、阻流膜15以及将网盘11缝合于阻流膜15上的缝合部16。为了实现封堵器10的远端和近端分别与推送管221和牵引件222的远端可拆卸连接，封堵器10的远端和近端分别设置远端封头12和近端栓头13。远端封头12通过带有内螺纹141的锁定件14与牵引件222的外螺纹2221相连接，近端栓头13设有与推送管221的远端设置的内螺纹2211相互配合的外螺纹131。进而在释放或回收封堵器10时只需旋转推送管221和牵引件222即可解除或建立与封堵器10的连接。当然可以理解的，参阅图25，近端栓头13设有供锁定件14穿过并锁定的锁定孔132， 牵引件222沿轴向相对于推送管221相对运动以促使锁定件14带动远端封头12靠近或远离近端栓头13，实现封堵器10的展开与收拢。
可以理解的是，在其他实施例中，在锁定件14的近端也可以不设置内螺纹141，锁定件14也可以与牵引件222通过卡扣的形式可拆卸连接。即，锁定件14与牵引件222之间的连接可以为其他连接方式，在此不一一列举，只要能够保证锁定件14与牵引件222之间为可拆卸连接即可。
同时参阅图4和图5b，为了实现牵引件222在推送管221内活动，推送管221的近端通过固定件213安装在手柄21的壳体上，为了便于手柄21内部构件的装配，手柄21的壳体由面盖212和底壳211围合形成。相应的固定件213将推送管221的近端固定在底壳211上，并使牵引件222从推送管221穿过以将牵引件222的近端连接在平移机构215上，随平移机构215的驱动在推送管221内运动。可以理解的，牵引件222近端从穿出推送管221的近端到连接在平移机构215的过程中，会经过锁定组件214来实现对牵引件222的锁定或释放，进而可以锁定牵引件222与推送管221之间的相对位置。
同时参阅图6至图8，在一些实施方式中，锁定组件214包括固定座2141、活动件2142以及用于调节活动件2142与固定座2141之间孔隙2145的调节结构。可以理解的，调节结构通过调节孔隙2145的大小以实现对牵引件222的锁定或释放，调节的方式可以采用按压的方式使活动件2142与固定座2141夹紧，也可以采用套在活动件2142和固定座2141上的环形件，使其沿轴向运动时对活动件2142和固定座2141进行箍紧的方式。下面就箍紧的方式对调节结构作进一步说明。
同时参阅图7和图8，在一些实施方式中，调节结构包括套设在固定座2141和活动件2142上的套筒2143以及使套筒2143沿轴向相对于固定座2141和活动件2142运动的锁轮2144。
具体的，固定座2141固定在手柄21内，套筒2143与锁轮2144通过螺纹连接。这样旋转锁轮2144便可以驱使套筒2143沿轴向运动，以紧箍或释放固定座2141和活动件2142，进而达到锁定牵引件222，进而锁定或释放穿过活动件2142与固定座2141之间孔隙2145的牵引件222。可以理解的，套筒2143在 垂直于轴向的横截面上的投影的最小内切圆的直径小于固定座2141和活动件2142的最大外接圆的直径；这样才能保证套筒2143相对于固定座2141和活动件2142轴向运动时，可以将固定座2141和活动件2142紧箍在一起对牵引件222形成夹持力。当然，这种轴向的相对运动需要对锁轮2144和固定座2141的轴向相对位置作出限定。参阅图8，固定座2141沿径向往外开设的侧棱21411将固定座2141轴向限位在手柄21的底壳212上，同样，锁轮2144也是轴向限位于手柄21的底壳212上，且为了便于操作锁轮2144，锁轮2144的轮毂21441至少部分露出于手柄21。
继续参阅图8，在一些实施方式中，套筒2143内形成有锥形盲孔21431，活动件2142与固定座2141配合形成圆台，圆台位于锥形盲孔21431内；套筒2143远离锥形盲孔21431的开口21431a的一端21431b通过螺杆21432与锁轮2144螺纹连接。锥形盲孔21431与圆台的靠近和远离，实现固定座2141与活动件2142之间的夹紧或松开。当然，本实施方式中，通过螺杆21432的方式螺纹传动只是为了缩减结构占用空间，方便设置直径较大的锁轮2144以提高抗扭力性能。可以理解的，直接将锁轮2144的内螺纹配合于套筒2143外壁的外螺纹上，也能实现对套筒2143的轴向驱动。
同时参阅图6和图9，在一些实施方式中，平移机构215包括第一转动件2151、第二转动件2152、直线导轨2153、平衡滑轨2155以及水平驱动组件2154。第一转动件2151沿轴向设有供牵引件222贯穿的通孔21541b。第二转动件2152与第一转动件2151同轴设置；直线导轨2153和平衡滑轨2155分别平行于第一转动件2151的转动轴线设置于第一转动件2151和第二转动件2152上。牵引件222的近端穿过第一转动件2151的通孔21541b固定在水平驱动组件2154上，以在水平驱动组件2154的驱动下沿直线导轨2153和平衡滑轨2155作直线往复运动，进而相对于固定在手柄21上的推送管221轴向运动，以实现对封堵器10的收拢与展开。
同时参阅图9和图13，在一些实施方式中，水平驱动组件2154包括牵引件安装座21541以及与牵引件安装座21541相连的推制21542。牵引件安装座21541滑设于直线导轨2153和平衡滑轨2155上，牵引件222的近端固定于牵引件安 装座21541上。推制21542至少部分露出于手柄21，以便推动牵引件安装座21541沿第一导轨和平衡滑轨2155运动。可以理解的，牵引件222可以通过沿牵引件安装座21541径向穿设的锁丝21541d固定，也可以通过焊接等其他方式固定在牵引件安装座21541上。
参阅图12，在一些实施例中，为了避免牵引件安装座21541在推送牵引件222时不受阻滞而推送过快，在平衡滑轨2155的表面上沿牵引件安装座21541的运动方向设有阻尼棱21551，牵引件安装座21541内设有与阻尼棱21551弹压相抵的滑动件21545。这样牵引件安装座21541在沿轴向滑动时，与平衡滑轨2155表面的阻尼棱21551会有阻滞感，使手术过程中能够缓慢释放封堵器10，从而减少推动过快造成的不利影响。
具体的，保持滑动件21545与阻尼棱21551弹压相抵，可以通过在滑动件21545远离阻尼棱21551的一端设有弹性件21544，以将滑动件21545挤向阻尼棱21551。可以理解的，为了降低滑动过程的磨损或者避免阻滞感过强而不便推动牵引件安装座21541，滑动件21545与阻尼棱21551相抵接处为曲面。
同时参阅图10和图11，上述实施方式中，牵引件安装座21541沿径向上开始有与阻尼棱21551一侧相通的通孔21541b，以提供弹性件21544和滑动件21545的安装空间。弹性件21544采用弹簧2166，滑动件21545为滚珠，弹簧2166的底部抵压在滚珠上使滚珠与阻尼棱21551相抵，弹簧2166的顶部通过锁紧件21543沿牵引件安装座21541径向限制住。可以理解的，锁紧件21543是安装于通孔21541b一侧的平头螺钉，相应的，在牵引件安装座21541上开设螺纹孔21541a以与平头螺钉配合锁紧下压弹簧2166。
在一些实施方式中，推制21542轴向限位于牵引件安装座21541上，第一转动件2151和第二转动件2152通过直线导轨2153和平衡滑轨2155传动牵引件安装座21541相对于推制21542绕第一转动件2151的转动轴线旋转。牵引件安装座21541带动牵引件222在推送管221内绕轴向旋转，进而实现与封堵器10的锁定件14的连接与分离。
在一些实施方式中，牵引件安装座21541与推制21542之间通过周向上相互配合的限位棱21541c和限位槽21542c实现轴向限位，且限位棱21541c与限 位槽21542c在配合处的横截面为圆形，以实现牵引件安装座21541相对于推制21542旋转。可以理解的，限位棱21541c可以设置在牵引件安装座21541上，也可以设置在推制21542上。当限位棱21541c设置在牵引件安装座21541上时，推制21542上设置与限位棱21541c相配合的限位槽21542c；当限位棱21541c设置在推制21542上时，牵引件222上设置与限位棱21541c相配合的限位槽21542c。本实施方式中，参阅图12所示，牵引件安装座21541和推制21542分别设有相互配合的限位棱21541c和限位槽21542c，可以理解的，推制21542包括推制底座21542a和推制上盖21542b，以便于在牵引件安装座21541上装配推制21542。
在一些实施例中，为了方便牵引件安装座21541相对于推制21542旋转，在第二转动件2152上远离第一转动件2151的一端设有旋转机构216。转动旋转机构216以带动第二转动件2152转动，进而通过直线导轨2153和平衡滑轨2155带动牵引件安装座21541绕轴向旋转。
具体的，参阅图15，在一些实施例中，旋转机构216包括基座2161和调节杆2162。基座2161为中空的筒体，固定于手柄21的壳体上；调节杆2162可滑动的插入在基座2161内，且与第二转动件2152旋转联动。这样使调节杆2162在基座2161内转动，可以联动第二转动件2152旋转。可以理解的，同时参阅图14及图18至图20，第二转动件2152通过转轴控制杆2156插设于沿调节杆2162轴向开设的插槽21625内，且在垂直于轴线的截面为非圆形，即，插槽21625允许转轴控制杆2156沿轴向运动而仅限制转轴控制杆2156的旋转自由度，以实现绕轴向的旋转联动。
在一些实施方式中，锁止结构设于基座2161与调节杆2162上，锁止结构具有锁定状态和解锁状态；锁定状态和解锁状态分别约束和释放调节杆2162在基座2161内的旋转自由度；沿轴向调节调节杆2162与基座2161的相对位置，可将锁止结构置于锁定状态或解锁状态。从而防止推送装置20在推送封堵器10的过程中，因误触调节杆2162而导致第二转动件2152旋转，使与牵引件安装座21541固定连接的牵引件222的远端脱离与封堵器10的锁紧件21543之间的牵制，影响封堵器10的释放。
同时参阅图16至图18，在一些实施方式中，锁止结构包括止动片21612和止动齿21621以及环形槽21611。止动片21612绕基座2161的内侧壁周向间隔设置；止动齿21621绕调节杆2162的外侧壁绕周向间隔设置，且相邻止动齿21621之间形成齿槽21622。环形槽21611绕基座2161的内侧壁周向开设。使调节杆2162在基座2161内旋转时，止动齿21621可以在环形槽21611内转动。沿轴向调节调节杆2162与基座2161的相对位置，可将止动片21612卡接于齿槽21622内或将止动齿21621移动至环形槽21611内。以实现调节杆2162与基座2161之间旋转自由度的限制或释放，可以理解的，在限制调节杆2162与基座2161之间旋转自由度时，即使误触调节杆2162，调节杆2162也不会绕轴向转动，进而避免误触推送装置20而引发牵引件222旋转脱离与封堵器10的连接，确保了封堵器10释放的准确性。
在一些实施方式中，基座2161的内侧壁与调节杆2162的外侧壁上设有卡位结构，以使调节杆2162在无外力干涉下轴向限位于基座2161内。进而使调节杆2162与基座2161保持在旋转自由度的锁定或释放状态，避免调节杆2162在操作过程中因误触而解除了与基座2161的旋转自由度的锁定。
同时参阅图15、图17和图19，在一些实施方式中，旋转机构216还包括旋盖2164、弹簧座2165以及弹压于弹簧座2165与旋盖2164之间的弹簧2166。旋盖2164固定于调节杆2162远离第二转动件2152的一端；弹簧座2165套设于基座2161上。旋盖2164可以通过紧固螺丝2163与调节杆2162固定连接，当然也可以通过卡扣等连接方式实现固定。本实施方式中，结合图21所示，卡位机构包括卡环21613和第一卡槽21623，卡环21613从基座2161的内侧壁沿径向延伸并与调节杆2162的外侧壁相抵接；第一卡槽21623于调节杆2162的外侧壁绕周向开设；卡环21613与第一卡槽21623卡扣时，止动片21612卡接于齿槽21622内。这样在卡环21613和第一卡槽21623的限位下，调节杆2162轴向与基座2161保持在旋转自由度被锁定的状态，即调节杆2162不能相对于基座2161旋转，避免误触造成牵引件222旋转。当卡环21613与第一卡槽21623解除卡扣时，在弹簧2166的弹性力下驱使调节杆2162上的止动槽脱离止动片21612而位于环形槽21611内，这样，可以通过转动旋盖2164对牵引件222进 行旋转操作，实现封堵器10脱离连接而释放或建立连接进行回收。
优选的，结合图22所示，卡位结构还包括第二卡槽21624，第二卡槽21624于调节杆2162的外侧壁绕周向开设；卡环21613与第二卡槽21624卡扣时，止动齿21621位于环形槽21611内。第二卡槽21624与卡环21613的配合可以将调节杆2162与基座2161保持在旋转自由度的释放状态，以避免弹簧2166出现故障时不足以保持调节杆2162旋转自由度处于释放状态，进而提高操作的安全性，确保推送装置20不会因误触而导致牵引件222旋转脱离封堵器10。
同时参阅图24和图25，推送装置20在操作封堵器10时，与手柄21相连的推送组件22依次穿过止血阀50、导引鞘管30和预装载器40，推送组件22的推送管221和牵引件222分别与封堵器10的近端栓头13和锁定件14相连接。进而可以通过推动手柄21上的推制21542向远端运动以控制牵引件222沿推送管221向远端移动，使锁紧件21543带动远端封头12远离近端栓头13对封堵器10沿轴向拉伸塑形。继续向远端推动推制21542，使封堵器10完全收拢至如图26所示状态，转动手柄21上的锁轮2144的轮毂21441，锁定牵引件222与推送管221之间的相对位置，使封堵器10保持在收拢状态。参阅图27，向近端拉动推送组件22即可将封堵器10经预装载器40进入导引鞘管30中。从导引鞘管30上取下预装载器40，并将导引鞘管30远端与输送鞘管60的近端相连，即完成封堵器输送系统的装载封堵器10的操作。参阅图28，通过封堵器输送系统将封堵器10经输送鞘管60推送，至预设位置进行封堵器10的展开和释放。可以理解的，由于推送装置20控制牵引件222在推送管221内的运动是可逆的，即解开锁定组件214对牵引件222的锁定后，朝近端推动推制21542，使牵引件222带动锁丝21541d靠近与推送管221远端连接的近端栓头13，进而可以将封堵器10从收拢状态调节为展开状态。在推送装置20调节封堵器10的状态过程中，牵引件安装座21541在沿轴向滑动时，与平衡滑轨2155表面的阻尼棱21551会有阻滞感，使手术过程中能够缓慢释放封堵器10，从而减少推动过快造成的不利影响。
以上实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特 征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (17)

  1. 一种封堵器推送装置，其特征在于，包括：
    推送组件，包括推送管以及可滑动的插入在所述推送管内部的牵引件；
    手柄，与所述推送管的近端固定连接，内设有运动组件以及锁定组件；
    所述运动组件包括平移机构和旋转机构；其中，所述平移机构用于驱动所述牵引件在所述推送管内沿轴向运动；所述旋转机构用于驱动所述牵引件在所述推送管内绕轴线转动；
    所述锁定组件用于锁定所述牵引件与所述推送管的相对位置；
    所述旋转机构包括锁止结构以锁定或释放与所述牵引件之间的联动。
  2. 根据权利要求1所述的封堵器推送装置，其特征在于，所述平移机构包括：
    第一转动件，沿轴向开设供所述牵引件贯穿的通孔；
    第二转动件，与所述第一转动件同轴设置；
    直线导轨和平衡滑轨，分别平行于所述第一转动件的转动轴线设置于所述第一转动件和第二转动件上；
    水平驱动组件，用于驱动所述牵引件的近端沿所述直线导轨和平衡滑轨作直线往复运动。
  3. 根据权利要求2所述的封堵器推送装置，其特征在于，所述水平驱动组件包括：
    牵引件安装座，滑设于所述直线导轨和平衡滑轨上，所述牵引件的近端固定于所述牵引件安装座上；
    推制，与所述牵引件安装座相连，且至少部分露出于所述手柄，以推动所述牵引件安装座沿所述第一导轨和平衡滑轨运动。
  4. 根据权利要求2所述的封堵器推送装置，其特征在于，其特征在于，所述旋转机构设于所述第二转动件上远离所述第一转动件的一端，所述旋转机构还包括：
    基座，中空的筒体，固定于所述手柄的壳体上；
    调节杆；可滑动的插入在所述基座内，与所述第二转动件旋转联动；
    所述锁止结构设于所述基座与所述调节杆上，所述锁止结构具有锁定状态和解锁状态以分别约束和释放所述调节杆在所述基座内的旋转自由度；
    沿轴向调节所述调节杆与所述基座的相对位置，可将锁止结构置于锁定状态或解锁状态。
  5. 根据权利要求3所述的封堵器推送装置，其特征在于，所述平衡滑轨的表面上沿所述牵引件安装座的运动方向设有阻尼棱，所述牵引件安装座内设有与所述阻尼棱弹压相抵的滑动件。
  6. 根据权利要求3所述的封堵器推送装置，其特征在于，所述推制轴向限位于所述牵引件安装座上，所述第一转动件和第二转动件通过所述直线导轨和平衡滑轨传动所述牵引件安装座相对于所述推制绕所述第一转动件的转动轴线旋转。
  7. 根据权利要求4所述的封堵器推送装置，其特征在于，所述锁止结构包括：
    止动片，于所述基座的内侧壁周向间隔设置；
    止动齿，于所述调节杆的外侧壁绕周向间隔设置，相邻止动齿之间形成齿槽；
    环形槽，绕所述基座的内侧壁周向开设，且所述调节杆在所述基座内旋转时，所述止动齿在所述环形槽内转动；
    沿轴向调节所述调节杆与所述基座的相对位置，可将所述止动片卡接于所述齿槽内或将所述止动齿移动至所述环形槽内。
  8. 根据权利要求6所述的封堵器推送装置，其特征在于，所述牵引件安装座与所述推制之间通过周向上相互配合的限位棱和限位槽实现轴向限位，且所述限位棱与所述限位槽在配合处的横截面为圆形，以实现所述牵引件安装座相对于所述推制旋转。
  9. 根据权利要求7所述的封堵器推送装置，其特征在于，所述基座的内侧壁与所述调节杆的外侧壁上设有卡位结构，以使所述调节杆在无外力干涉下轴向限位于所述基座内。
  10. 根据权利要求9所述的封堵器推送装置，其特征在于，所述旋转机构还包括：
    旋盖，固定于所述调节杆远离所述第二转动件的一端；
    弹簧座，套设于所述基座上；
    弹簧，弹压于所述弹簧座与所述旋盖之间；
    所述卡位机构包括卡环和第一卡槽，所述卡环从所述基座的内侧壁沿径向延伸并与所述调节杆的外侧壁相抵接；所述第一卡槽于所述调节杆的外侧壁绕周向开设；
    所述卡环与所述第一卡槽卡扣时，所述止动片卡接于所述齿槽内。
  11. 根据权利要求10所述的封堵器推送装置，其特征在于，所述卡位结构还包括第二卡槽，所述第二卡槽于所述调节杆的外侧壁绕周向开设；
    所述卡环与所述第二卡槽卡扣时，所述止动齿位于所述环形槽内。
  12. 根据权利要求1至11任意一项权利要求所述的封堵器推送装置，其特征在于，所述锁定组件包括：
    固定座；固定于所述手柄内；
    活动件，与所述固定座之间形成供所述牵引件穿过的孔隙；
    调节结构，用于调节所述活动件与所述固定座之间的孔隙，以锁定或释放所述牵引件。
  13. 根据权利要求12所述的封堵器推送装置，其特征在于，所述调节结构包括：
    套筒，套设于所述固定座和活动件上，且所述套筒在垂直于轴向的横截面上的投影的最小内切圆的直径小于所述固定座和活动件的最大外接圆的直径；
    锁轮，轴向限位于所述手柄内，与所述套筒螺纹连接；
    所述锁轮的轮毂至少部分露出于所述手柄，以旋转所述锁轮螺纹传动所述套筒沿轴向运动，而使所述套筒紧箍或释放所述固定座和活动件。
  14. 根据权利要求13所述的封堵器推送装置，其特征在于，所述套筒内形成有锥形盲孔，所述活动件与所述固定座配合形成圆台，所述圆台位于所述锥形盲孔内；所述套筒远离锥形盲孔的开口的一端通过螺杆与所述锁轮螺纹连接。
  15. 一种封堵器输送系统，其特征在于，包括权利要求1至14任一项所述推送装置，以及
    输送鞘管，为中空的软管；所述推送装置的推送管可滑动的插入至所述输送鞘管内；
    鞘芯，连接于所述输送鞘管的近端，用于调节输送鞘管的弯曲方向，以使所述推送管沿所述输送鞘管将封堵器推送至待封堵的缺损处。
  16. 根据权利要求15所述的封堵器输送系统，其特征在于，所述输送系统还包括止血阀，所述输送鞘管与所述止血阀之间可拆卸地连接有中空的导引鞘管，所述导引鞘管的内腔与所述输送鞘管及所述止血阀的内腔相连通。
  17. 根据权利要求16所述的封堵器输送系统，其特征在于，所述输送系统还包括与所述导引鞘管的远端可拆卸连接的预装载器，所述预装载器包括喇叭段和接口段以及连接于喇叭段与接口段之间的连接段。
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US20200222034A1 (en) 2020-07-16
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CN109247959B (zh) 2020-07-03
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