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WO2018121363A1 - Appareil de pose et système de pose - Google Patents

Appareil de pose et système de pose Download PDF

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Publication number
WO2018121363A1
WO2018121363A1 PCT/CN2017/117296 CN2017117296W WO2018121363A1 WO 2018121363 A1 WO2018121363 A1 WO 2018121363A1 CN 2017117296 W CN2017117296 W CN 2017117296W WO 2018121363 A1 WO2018121363 A1 WO 2018121363A1
Authority
WO
WIPO (PCT)
Prior art keywords
hook
rod
base
distal end
slot
Prior art date
Application number
PCT/CN2017/117296
Other languages
English (en)
Chinese (zh)
Inventor
姚斌
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
Publication of WO2018121363A1 publication Critical patent/WO2018121363A1/fr

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices

Definitions

  • the present invention relates to the field of medical devices, and more particularly to a delivery device and delivery system for delivering an implanted medical device.
  • vascular stent vascular stent
  • heart valve heart defect occluder
  • vascular plug vascular filter
  • vascular filter vascular filter
  • interventional medical devices are placed into the heart and arteriovenous blood vessels of the human body through the catheter intervention method, since the anatomical structure of the human heart and arteriovenous blood vessels is complicated, it is necessary to use the delivery device to ensure that the interventional medical device accurately reaches the predetermined site.
  • Current delivery devices include catheters, guidewires, and pushers. The catheter is guided by the guide wire and first reaches the predetermined site. In performing such procedures, very small flexible catheters are required, while catheters and guidewires have good development performance under X-rays. After the catheter reaches the predetermined site, the guidewire is removed, the interventional medical device is placed into the catheter, and the interventional medical device is guided to the end of the catheter by a channel established by the catheter.
  • the interventional medical device When the interventional medical device reaches the end of the catheter, the interventional medical device is released from the catheter. If it is determined during the release process that the position of the interventional medical device is not good, the interventional medical device needs to be recovered again into the catheter and released again. Finally, the interventional medical device should be disconnected from the pusher.
  • the present invention provides a delivery device capable of radially controlling a medical device to prevent tissue injury and reduce damage to the human body.
  • the invention provides a conveying device comprising a hook mechanism and an ejection mechanism, the hook mechanism comprising at least two hollow hook rods and a first base having at least two first peripheral through holes, at least two hooks
  • the rod is disposed at a distal end surface of the first base, and corresponds to at least two first peripheral through holes, and the hook rod lumen communicates with a corresponding first peripheral through hole thereof
  • a first slot is disposed at a position near the distal end of the hook rod and a cover body disposed above the first slot slot and covering the slot of the first slot portion, wherein the cover body is a proximal end of the first slot is adjacent to a distal end of the hook rod, and a gap is formed between the cover body and a groove bottom of the first slot
  • the pushing mechanism includes at least two push rods, the push rod a second slot is provided at a position near the distal end, and one of the push rods is inserted from a proximal end of the first base into a hook-shaped
  • each of the ejecting rod and the hook rod are gradually away from the longitudinal central axis of the delivery device from the proximal end to the distal end.
  • the conveying device further comprises a retracting mechanism comprising a retractable tray and a receiving tube connected to the proximal end surface of the retractable tray, the retractable tray being provided with at least two a third peripheral through hole and a central through hole corresponding to at least two of the hook rods, a distal end of one of the hook rods passing from a proximal end surface of the receiving tray through a third periphery corresponding thereto a through hole passes through a distal end surface of the receiving and unloading disc, the first base is provided with a central through hole, and a proximal end of the receiving tube passes through a central through hole of the first base from a distal end surface of the first base The proximal end surface of the first base is worn out.
  • a retracting mechanism comprising a retractable tray and a receiving tube connected to the proximal end surface of the retractable tray, the retractable tray being provided with at least two a third peripheral through hole and a central through hole corresponding to at least two
  • the hook mechanism further includes a delivery tube disposed at an end surface of the proximal end of the first base, the lumen of the delivery tube is in communication with a central through hole of the first base, and the retracting mechanism
  • the storage tube is housed in the delivery tube.
  • the inner wall of the conveying pipe is provided with a limiting protrusion protruding inward in the radial direction of the conveying pipe
  • the outer wall of the receiving pipe is provided with a convex outward along the radial direction of the receiving pipe
  • the limiting protrusions on the inner wall of the conveying pipe are farther from the proximal end of the conveying device than the limiting protrusions on the outer wall of the receiving pipe.
  • the ejection mechanism further includes a second base having a central through hole and an ejection tube disposed on a distal end surface of the second base, the lumen of the ejection tube and the second base Central
  • the through holes are connected, the lumen of the push-out tube is for receiving the conveying tube, and the proximal ends of the at least two protruding rods are disposed on the distal end surface of the second base, and surround the second base Central through hole.
  • the ejecting tube is provided with a limiting step
  • the outer wall of the conveying tube is provided with a limiting protrusion along the radial direction of the conveying tube, and the limiting step is larger than the outer wall of the conveying tube
  • the limit tab is remote from the proximal end of the delivery device.
  • the distance from the center of each of the hooked bars to the longitudinal central axis of the hook assembly is equal in a cross section perpendicular to the longitudinal central axis of the hook assembly .
  • the distance from the center of each of the ejecting rods to the longitudinal central axis of the ejecting member is equal in a cross section that is perpendicular to the longitudinal central axis of the ejecting assembly.
  • the distal end of the hook rod is provided with a distal slot, and the distal slot of the hook rod is closer to the hook rod than the first slot remote.
  • the distal end of the push rod is provided with a distal slot, the distal slot of the push rod being closer to the distal end of the push rod than the second slot.
  • a plurality of grooves are formed in the wall of the hook rod or the push rod.
  • the distance between adjacent ones of the hooked rods or the ejecting rods is increasingly greater from the proximal end to the distal end of the delivery device.
  • the present invention also provides a delivery system comprising a delivery device and a medical device coupled to the delivery device, the medical device comprising a loop, the loop being receivable in the receiving space.
  • the cover body of the hook rod of the hook mechanism can form a closable accommodation space with the second slot of the push rod received in the hook rod.
  • the medical device Under the restraint of the retractable mechanism, not only can the medical device be radially restricted, but the controllability and safety of the delivery can be improved.
  • FIG. 1 is a schematic structural view of a conveying system according to a first embodiment of the present invention
  • FIG. 2 is a schematic structural view of a hook mechanism of the conveying device of the conveying system of FIG. 1;
  • FIG. 3 is a schematic structural view of a first base of the hook mechanism of FIG. 2;
  • Figure 4 is a partial structural view of the hook rod of the hook mechanism of Figure 2;
  • Figure 5 is a schematic view showing the structure of the pushing mechanism of the conveying device of the conveying system of Figure 1;
  • Figure 6 is a schematic structural view of the second base of the ejecting mechanism of Figure 5;
  • Figure 7 is a partial structural schematic view of the push-out lever of the push-out mechanism of Figure 5;
  • Figure 8 is a schematic view showing a state in which the first slit of the conveying device of the conveying system of Figure 1 is blocked by a limit cover;
  • Figure 9 is a schematic view showing a state in which a first slit of the conveying device of the conveying system of Figure 1 is exposed from a hook-shaped slit;
  • Figure 10 is a schematic view showing a state in which the first slit of the conveying device of the conveying system of Figure 1 is completely exposed from the hook-shaped slit;
  • Figure 11 is a schematic structural view of the retracting mechanism of the conveying system of Figure 1;
  • Figure 12 is a schematic view showing a state in which a medical device attached to a delivery device is contracted in an outer sheath tube;
  • Figure 13 is an enlarged view of a portion A in Figure 12;
  • Figure 14 is a schematic view showing a state in which a medical device attached to a delivery device is exposed from an outer sheath tube;
  • Figure 15 is a schematic view showing a state in which the delivery device is separated from the medical device
  • Figure 16 is an enlarged view of B in Figure 15;
  • Figure 17 is a schematic view showing the state of the delivery device when it is withdrawn from the human body
  • Figure 18 is a schematic structural view of a conveying device according to a second embodiment of the present invention.
  • Figure 19 is a partial structural schematic view of the hook rod of the conveying device of Figure 18;
  • Figure 20 is a partial structural schematic view of the ejecting rod of the conveying device of Figure 18;
  • Figure 21 is a schematic view showing the state in which the second slit of the conveying device of Figure 18 is accommodated at the distal slit;
  • Figure 22 is a schematic view showing a state in which the first slit of the conveying device of Figure 18 is completely exposed from the hook-shaped slit;
  • FIG. 23 is a schematic structural view of a connection between a delivery device and a medical device according to a second embodiment
  • FIG. 24 is a schematic structural view of a conveying device of a conveying system according to a third embodiment of the present invention.
  • Figure 25 is a schematic structural view of a hook rod of the conveying device of Figure 24;
  • Figure 26 is a schematic view showing the structure of the ejecting rod of the conveying device of Figure 24.
  • the following embodiments are described by taking the delivery device of the stent as an example.
  • the concept of the present invention can also be applied to a delivery device of a medical device such as a heart valve or an occluder having a stent.
  • a delivery system 300 includes a delivery device 100 and a medical device 200 including a loop 201 connected to the delivery device 100 .
  • the transport device 100 includes a hook mechanism 10, an ejecting mechanism 20, a retracting mechanism 30, and a handle mechanism 50 coupled to the hook mechanism 10, the ejecting mechanism 20, and the retracting mechanism 30.
  • the handle mechanism 50 is used to control the mutual movement between the hook mechanism 10, the push mechanism 20, and the retracting mechanism 30.
  • the pusher mechanism 20 distally penetrates the hook mechanism 10 and is movable relative to the hook mechanism 10.
  • the medical device 200 in this embodiment is a stent.
  • the medical device may also be a prosthetic heart valve with a stent (eg, a artificial mitral valve, an artificial tricuspid valve, an artificial aortic valve, or an artificial pulmonary valve).
  • a prosthetic heart valve with a stent eg, a artificial mitral valve, an artificial tricuspid valve, an artificial aortic valve, or an artificial pulmonary valve.
  • implantable medical devices such as cardiac defect occlusion devices, The device is required to have a through hole for connection to the delivery device.
  • the hook mechanism 10 includes a first base 12, a hollow hook rod 11 connected to the first base 12, and a conveying pipe 13 connected to the proximal end of the first base 12.
  • the first base 12 may have a disc shape as a whole. In other embodiments, the shape of the first base 12 may also have different shapes according to the shape of the medical device to be transported, such as an elliptical disc shape, a rectangular disc, etc. Specifically limited.
  • the first base 12 of the disc shape is provided with at least two first peripheral through holes 121 adjacent to the edge of the first base 12, and at least two first peripheral through holes 121.
  • the first base 12 is evenly distributed along the circumferential direction of the first base 12.
  • the number of the first peripheral through holes 121 is the same as the number of the hook rods 11 on the hook mechanism 10, and one-to-one correspondence.
  • the lumen of each of the hook rods 11 communicates with the first peripheral through hole 121 corresponding thereto.
  • the proximal end of the hook-shaped rod 11 is connected to the distal end surface of the first base 12, and the hook-shaped rod 11 and the first base 12 may be fixedly connected by welding, riveting, or the like, or may be integrally formed, and is not specifically limited herein.
  • a central through hole 122 surrounded by at least two first peripheral through holes 121 is also formed in the first base 12.
  • the conveying pipe 13 is disposed on the proximal end surface of the first base 12 and the lumen of the conveying pipe 13 communicates with the central hole 122.
  • the proximal end of the conveying pipe 13 is connected with the handle mechanism 50, and the conveying pipe 13 and the first base 12 can be It can be fixed by welding, riveting, etc.
  • Each of the hook rods 11 is made of a material having morphological memory characteristics, such as a nickel-titanium tube or a cobalt-lubricated tube, so that each hook-shaped rod 11 has a certain flexibility and shape memory property, that is, under the action of external force.
  • the hook rod 11 is capable of generating a bending deformation, and when the external force is removed, the hook rod 11 can be restored to a natural state.
  • the material of the conveying pipe 13 may be a metal material such as stainless steel, nickel titanium alloy or the like.
  • the conveying pipe 13 is the same as the first base 12 Material to facilitate a fixed connection between the two.
  • the hook rod 11 is a hollow tubular structure, the proximal end of which is connected to the distal end surface of the first base 12, and the lumen of the hook rod 11 communicates with the first peripheral through hole 121 of the first base 12.
  • At least two hook-shaped rods 11 are evenly distributed on one end of the distal end surface of the first base 12, and in a natural state (the hook-shaped rod 11 is not subjected to an external force), each of the hook-shaped rods 11 is from the proximal end to the far side.
  • the end gradually moves away from the central axis of the first base 12, that is, at least two hook-shaped rods 11 are substantially petal-shaped offset from the longitudinal center of the first base 12.
  • each of the hook rods 11 is offset from the longitudinal center axis of the hook assembly 10 to the same extent, that is, in any cross section perpendicular to the longitudinal center axis of the hook assembly 10, each hook The distance of the center of the section of the rod 11 taken from the cross section to the longitudinal center axis of the first base 12 is equal.
  • the degree of deviation of each of the hook rods 11 relative to the longitudinal central axis of the hook assembly 10 is also It may be different, and the degree of deviation of each of the hook rods 11 in the natural state with respect to the longitudinal center axis of the hook assembly 10 may be set according to actual needs. It will also be appreciated that in other embodiments, in the natural state, the longitudinal central axis direction of each of the hook rods 11 may also be parallel to the longitudinal center axis direction of the hook assembly 10.
  • At least two first peripheral through holes 121 opened by the first base 12 may also be disposed at any position between the central hole 122 of the first base 12 and the edge of the first base 12 when When at least two first peripheral through holes 121 are disposed near the central hole 122 of the first base 12, in a natural state, the plurality of hook rods 11 are offset from the longitudinal center axis of the first base 12 by at least two degrees.
  • the first peripheral through hole 121 is disposed at a position close to the edge position of the first base 12, and the degree of deviation of the plurality of hook rods 11 from the longitudinal center axis of the first base 12 is large.
  • a first slot 111 is defined in the position of the hook rod 11 near the distal end.
  • the notch direction of the first groove 111 faces away from the longitudinal center axis of the first base 12. It can be understood that in other embodiments, the slot direction of the first slot can also be in any other direction.
  • a cover 112 covering a portion of the opening of the first slit 111 is disposed above the notch of the first slit 111.
  • the cover body 112 is closer to the distal end of the hook rod 11 than the proximal end of the first slit 111, and a gap is formed between the cover body 112 and the groove bottom of the first slit 111.
  • the distal end of the cover body 112 can be fixedly connected to the distal end portion of the hook-shaped first slit 111 by welding, bonding or the like.
  • the cover body 112 is integrally formed with the hook-shaped rod 11, that is, a first slit 111 can be cut directly from the tubular hook-shaped rod 11 by cutting, and the corresponding cover is in the first
  • the portion of all slots 111 is the cover 112.
  • the cover 112 extends from the distal end to the proximal end of the first slot 111 and is parallel to the horizontal axis of the hook rod 11, and the cover 112 will be first cut.
  • the hook rod 11 is integrally formed with the first base 12, that is, the hook rod 11 extends from the distal end surface of the first base 12.
  • the pushing mechanism 20 includes a second base 22, a hollow push rod 21 connected to the second base 22, and a push-out tube 23 connected to the proximal end of the second base 22.
  • the second base 22 may have a disc shape as a whole. In other embodiments, the shape of the second base 22 may also have a different shape depending on the shape of the medical device to be delivered, such as an elliptical disc shape, a rectangular disc, or the like.
  • the second base 22 of the ejector mechanism 20 is provided with at least two second peripheral through holes 221 near the edge of the second base 22, and the number of the second peripheral through holes 221 of the second base 22 is open to the first periphery of the first base 12.
  • the number of holes 121 is the same.
  • At least two second peripheral through holes 221 on the second base 22 are evenly distributed on the second base 22 along the circumferential direction of the second base 22.
  • the at least two push-out bars 21 are in one-to-one correspondence with the at least two second peripheral through-holes 221, and the lumens of each of the push-out bars 21 are in communication with the second peripheral through-holes 221 corresponding thereto.
  • the second peripheral through hole may be omitted, as long as the push-out bar may be disposed at the distal end surface of the second base.
  • the proximal end of the ejecting rod 21 is connected to the distal end surface of the second base 22, and the ejecting rod 21 and the second base 22 may be fixedly connected by welding, riveting, or the like, or may be integrally formed, and is not specifically limited herein.
  • a central hole 222 surrounded by at least two second peripheral through holes 221 is also formed in the second base 22.
  • the push-out tube 23 is disposed on the proximal end surface of the second base 22 and the lumen of the push-out tube 23 communicates with the central bore 222 of the second base 22. The proximal end of the push-out tube 23 is coupled to the handle mechanism 50.
  • the distal end of the ejecting tube 23 and the second base 22 may be fixedly connected by welding, riveting, or the like, or may be integrally formed. It can be understood that, in other embodiments, the outer diameter of the push-out tube 23 can be the same as the outer diameter of the second base 22.
  • the second base and the push-out tube can be regarded as a unitary structure, collectively referred to as a second base or The tube is pushed out, and the push rod is disposed at the distal end surface of the second base or at the distal end surface of the push tube.
  • each of the push-out rods 21 may be made of a material having morphological memory characteristics, such as a nickel-titanium tube or a cobalt-lubricated tube, so that each of the push-out rods 21 has a certain flexibility and shape memory characteristics, that is, in an external force. Under the action, the push-out lever 21 can generate a bending deformation, and when the external force is removed, the push-out lever 21 can be restored to a natural state.
  • the material of the push-out tube 23 may be a metal material such as stainless steel, nickel-titanium alloy or the like.
  • the push-out tube 23 is the same as the second base 22 Material to facilitate a fixed connection between the two.
  • the rod 21 is a hollow tubular structure, the proximal end of which is connected to the distal end surface of the second base 22, and the lumen of the push-out rod 21 communicates with the through hole of the second base 22.
  • the outer diameter of the push rod 21 is smaller than the inner diameter of the hook rod 11, the number of the push rods 21 is the same as the number of the hook rods 11 on the first base 12, and the positions of the plurality of push rods 21 on the second base 22 One-to-one correspondence with the positions of the plurality of hook-shaped rods 11 of the first base 12 ensures that an ejection rod 21 can penetrate into the lumen of a hook-shaped rod 11.
  • each of the push-out levers 21 gradually moves away from the longitudinal center axis of the second base 22 (i.e., the longitudinal center axis of the push-out mechanism 20) from the proximal end to the distal end, that is, It is said that the plurality of ejecting rods 21 are substantially petal-shaped deviated from the longitudinal central axis of the second base 22, the degree of deviation of each of the ejecting rods 21 with respect to the longitudinal central axis of the second base 22 and the hook-shaped rods 11 relative to the first base 12
  • the longitudinal center axis is offset to the same extent. It can be understood that in other embodiments, in the natural state, the longitudinal central axis direction of each of the push rods 21 may also be parallel to the longitudinal central axis direction of the push-out assembly 20.
  • the proximal end of the push rod 21 is provided with a second slot 211 with a slot direction away from the longitudinal central axis of the push mechanism 20, and the slot length 213 of the second slot 211 is smaller than the hook rod.
  • the notch of the first slit 111 on the upper surface of the cover portion 11 is not covered by the cover 112. That is, the notch length 213 of the second slit 211 is smaller than the vertical distance 115 between the proximal end surface of the cover 112 and the proximal end surface of the first slit 111 to ensure that the push rod 21 penetrates the hook rod.
  • the second slit 211 when the second slit 211 is required to be exposed from the first slit 111, the second slit 211 can be completely exposed from the opening of the hook-shaped first slit 111. It can be understood that in other embodiments, the slot direction of the second slot can also be other directions.
  • the number of the pushing rods 21 is the same as the number of the hook rods 11 , and the positions are in one-to-one correspondence, that is, the pushing mechanism 20
  • the distal end of each of the push rods 21 is inserted into the hook rod 11 of the corresponding hook mechanism 10 through a through hole in the first base 12.
  • the distal end of the ejection rod 21 extends into the distal end of the lumen of the hook rod 11, the distal end surface of the second base 22 is fitted to the distal end surface of the first base 12, and the output tube 13 of the hook mechanism 10 is extended to In the push-out tube 23 of the push-out mechanism 20, the distal end of the output tube 13 and the distal end of the push-out tube 23 are respectively connected to the handle mechanism 50 at the proximal end of the transport device 100, and the handle mechanism 50 can pass through the output tube 13 and the push-out tube connected thereto. 23 to control the relative movement between the push mechanism 20 and the hook mechanism 10.
  • the push mechanism 20 When the hook mechanism 10 is kept stationary, the push mechanism 20 is pushed distally by the handle mechanism 50 until the distal end surface of the second base 22 is attached to the distal end surface of the first base 12, and the push mechanism 20 moves relative to the hook mechanism 10 to At the farthest end, the second slot 211 of the push rod 21 is received in the hook-shaped first slot 111 of the hook rod 11, as shown in FIG. 8, the cover on the hook rod 11 will be the second slot.
  • the notch of the 211 is sealed, so that an accommodation space is formed between the cover 112 and the second slot 211.
  • the hanging loop 201 of the medical device 200 can be accommodated in the receiving space, so that the medical device 200 is attached to the transport device 100. .
  • the handle mechanism 50 controls the push mechanism 20 to move toward the proximal end, the first base 12 and the second base 22 are separated from each other.
  • the second slot 211 of the distal end of the rod 21 is pushed out along with the push rod.
  • the 21 moves toward the proximal end and is gradually exposed from the notch covered by the cover 112 of the first slit 111.
  • the slot length of the second slot 211 is smaller than the length of the first slot 111 without the cover portion, when the ejector mechanism 20 moves to the slot of the second slot 211, When fully exposed, please refer to FIG.
  • the accommodation space formed between the cover 112 and the second slot 211 is completely open, and the second slot 211 is in communication with the outside, and the medical device 200 accommodated in the accommodation space is hung.
  • the ring 201 can be removed from the second slit 211 to release the connection with the conveying device 100.
  • the retracting mechanism 30 includes a disc-shaped receiving and retracting disc 31 and a hollow retractable tube 32 disposed on the proximal end surface of the retractable disc 31.
  • the collecting tray 31 is provided with at least two third peripheral through holes 322 and one central through hole 321 .
  • the central through hole 321 communicates with the distal end of the hollow receiving tube 32.
  • the proximal end of the receiving tube 32 is connected to the handle mechanism 50, and the at least two third peripheral through holes 322 are evenly distributed in the central through hole along the circumferential direction of the receiving and receiving tray 31.
  • the number of the third peripheral through holes 322 is the same as the number of the hook rods 11 of the hook mechanism 10, and the radius of each of the third peripheral through holes 322 is larger than the radius of the hook rod 11, ensuring that the hook rod 11 can be Smooth sliding in the third peripheral through hole 322.
  • the radial length of the outer wall of the hoisting pipe 32 is smaller than the radial length of the inner wall of the output pipe 13, ensuring that the hoisting pipe 32 can smoothly slide in the output pipe 13.
  • a distal end of a hook rod 11 penetrates a peripheral through hole 322 from the proximal end of the take-up reel 31, and is passed out from the distal end surface of the take-up reel 31, while the proximal end of the retractable tube 32 is inserted into the hook mechanism 10 In the output tube 13 .
  • the retractable disk 31, the first base 12 and the second base 22 are coaxially disposed, that is, the central axes of the three are on the same straight line, and the distance from the center of the third peripheral through hole 322 of the receiving and retracting disk 31 to the central axis and the first base The distance from the center of the first peripheral through hole 121 to the central axis is equal.
  • the proximal end surface of the accommodating disc 31 is in contact with the distal end end of the first base 12, and the distal end of each hook rod 11 is inserted into each of the third peripheral through holes 322 from the proximal end of the accommodating disc 31.
  • the proximal end surface of the first base 12 is in contact with the distal end surface of the second base 22, and each of the push-out rods 21 penetrates into the hook-shaped rod 11 and is worn along with the hook-shaped rod 11 from the distal end surface of the take-up and reel 31
  • the portion through which the hook rod 11 and the push-out rod 21 pass out from the distal end surface of the take-up disc 31 gradually moves away from the center axis of the take-up tray 31 from the proximal end to the distal end.
  • the receiving tube 32 is pushed by the handle mechanism 50 to move the receiving tray 31 distally relative to the first base 12; as the receiving tray 31 gradually moves to the distal end, it gradually moves away from the proximal end to the distal end in the natural state.
  • the hook-shaped rod 11 and the push-out rod 21 of the center axis of the base 12 are restrained by the take-up disc 31 in a state substantially parallel to the central axis.
  • the outer wall of the output tube 13 of the hook mechanism 10 is provided with a first limiting protrusion 131 protruding outward in the radial direction of the output tube 13, and the output tube 13
  • the inner wall is provided with a fourth limiting protrusion 133 which is convexly inwardly along the radial direction of the output tube 13;
  • the ejection tube 23 of the pushing mechanism 20 is provided with a limiting step 231.
  • the ejection mechanism 20 moves toward the proximal end relative to the hook rod 11 to the proximal end surface of the limiting step 231 and the distal end surface of the first limiting protrusion 131 (ie, the ejection mechanism 20 is proximal to the hook rod 11)
  • the notch of the second slit 211 can be completely exposed from the notch of the first slit 111 of the hook rod 11 which is not covered by the cover 112, so as to conveniently hang each of the medical instruments 210
  • the ring 201 is hung on the notch of the second slot 211 of each of the push rods 21.
  • the outer wall of the retracting tube 32 of the retracting mechanism 30 is provided with a third limiting protrusion 321 which protrudes outward in the radial direction of the retracting tube 32.
  • a third limiting protrusion 321 which protrudes outward in the radial direction of the retracting tube 32.
  • the handle mechanism 50 controls the retraction mechanism 30, the ejection mechanism 20, and the hook.
  • the accommodating mechanism 30 and the ejector mechanism 20 can be accurately moved to a predetermined position, and the accommodating mechanism 30, the ejector mechanism 20, and the hook mechanism 10 of the transport device 100 of the present embodiment may not be required. Set the limit steps separately.
  • the hook mechanism 10, the push-out mechanism 20, and the retracting mechanism 30 are assembled in accordance with the aforementioned assembling method.
  • the notch of the second slit 211 of the push-out mechanism 20 moved to the push-out lever 21 can be completely exposed from the first slit 111 of the hook-shaped rod 11, and each of the hanging loops 201 of the medical device 200 is hung on each of the push-outs
  • the push mechanism 20 is further pushed to move distally relative to the hook mechanism 10, and the second slot 211 moves along the push rod toward the distal end of the hook rod 11, as shown in FIG. 12 and As shown in FIG.
  • the cover 112 on the hook rod 11 blocks the notch of the second slot 211, thereby forming a closed receiving space between the cover 112 and the second slot 211, and the hanging ring of the medical device 200
  • the receptacle 202 is received in the accommodating space, and the loop 202 of the medical device 200 cannot be detached from the second slot 211, thereby achieving a fixed connection between the loop 202 of the medical device 200 and the transport device 100, and pushing the retracting mechanism toward the distal end. 30, until the distal end surface of the take-up reel 31 is adjacent to the proximal end of the hook-shaped first slit 111 of the hook rod 11.
  • the hook-shaped rod 11 which is gradually away from the central axis of the accommodating disc 31 from the proximal end to the distal end in a natural state and the ejecting rod 21 penetrating therein are bound to be substantially parallel to the accommodating disc 31.
  • the state of the central axis, so that the medical device 200 connected to the hook rod 11 and the push-out rod 21 penetrating therein is also restrained, radially compressed, and the radially compressed medical device 200 is collected into the delivery device 100.
  • the outer sheath tube 40 is transported. During delivery, the medical device 200 is always in a radially compressed state because the loop 201 cannot be detached from the delivery device 100.
  • the medical device 200 needs to be released.
  • the outer sheath tube 40 is retracted, and then the retracting mechanism 30 is pulled toward the proximal end with respect to the hook rod 11, and the retractable tray 31 gradually approaches the first position.
  • the plurality of loops 201 are spaced apart from each other such that the medical device 200 gradually returns from a radially compressed state to a natural state. Referring to FIG. 15 and FIG.
  • the pushing mechanism 20 is moved proximally relative to the first base 12, the distal end surface of the second base 22 is gradually away from the proximal end surface of the first base 12, and the second slot 211 is moved proximally. It is gradually exposed from the notch of the first slit 111.
  • the notch of the second slot 211 is from When the notch of the first slot 111 is completely exposed, the receiving space formed between the cover 112 and the second slot cut 211 is completely opened, and the second slot 211 communicates with the outside to accommodate the hanging of the medical device in the receiving space.
  • the ring 201 can be removed from the second slit 211 to release the connection with the conveying device 100. Thereby the release of the medical device 200 is completed.
  • the retractable tray 31 is pushed toward the distal end of the conveying device 100 with respect to the first base 12, and the hook rod 11 deviating from the central axis is bound to be substantially parallel to the central axis, and then will be transported.
  • the device 100 is withdrawn and the implantation of the implant 200 of the medical device is completed.
  • the conveying device 100a according to the second embodiment of the present invention is substantially the same as the conveying device 100 provided by the first embodiment, and includes a hooking mechanism 10a, an ejecting mechanism 20a, and a retracting mechanism 30a.
  • the distal end of the hook rod 11a on the hook mechanism 10a is provided with a distal slit 113a, and the distal slit 113a is adjacent to the first slit 111a, and the distal slit is 113a is closer to the distal end of the hook rod 11a than the first slit 111a.
  • the slot direction of the distal slot 113a is the same as the slot direction of the hook-shaped first slot 111a, and the distal slot 113a extends through the distal end surface of the hook rod 11a, that is, the slot of the distal slot 113a is viewed from the side It is substantially L-shaped and has a first slit 111.
  • the distal end of the push rod 21a is provided with a distal slit 212a.
  • the distal slit 212a is closer to the distal end of the push rod 21a than the second slit 211a.
  • the shape of the distal slit 212a is substantially the same as the shape of the distal slit 113a on the hook rod 11a, and is substantially L-shaped when viewed from the side.
  • the push-out lever 21a penetrates into the lumen of the hook-shaped rod 11a, so that the distal slit 212a of the push-out rod 21a is partially accommodated in the hook-shaped rod. 11a inside the lumen.
  • the push-out lever 21a is moved distally relative to the hook-shaped rod 11a to the farthest position, the distal end of the distal slit 212a can be accommodated in the distal slit 113a of the hook-shaped rod 11a.
  • the proximal end of the hanging loop 202a is accommodated between the cover body 112a and the second slit 211a to form a receiving space.
  • the distal end of the hanging loop 202a can be received in the distal slit 113a of the hook rod 11a, and the distal slit 113a can play a supporting role for the hanging loop 202a, so that the hanging loop 202a can maintain an approximate level.
  • the state of the hook 202a is prevented from being turned down.
  • the distal slit 131a of the hook rod 11a has the same depth in the radial direction of the hook rod 11a as the second slit 211a of the push rod 21a in the radial direction of the push rod 21a, and the distal slit 113a
  • the radial depth of the hook rod 11a is the same as the depth of the second slit 211a of the push rod 21a in the radial direction of the push rod 21a to further ensure that the loop 202a is maintained in a horizontal state after being hooked to the push rod 21a.
  • a support structure such as a support step or a support rod can be welded to the distal end of the hook rod 11 of the first embodiment to support the distal end of the hanging ring, thereby preventing the hanging ring. 202a flips down.
  • a third embodiment of the present invention further provides a transport device 100b.
  • the transport device 100b is substantially identical to the transport device 100 provided by the first embodiment, except that in this embodiment
  • the conveying device 100b is provided with a plurality of grooves 114b spaced apart from the hook rod 11b.
  • the outer wall of the pushing rod 21b is spaced apart from the plurality of grooves 213b, thereby reducing the hardness of the pushing rod 21b and the hook rod 11b.
  • the rod 21b and the hook rod 11b are more easily bent.
  • the push-out rod 21b and the hook-shaped rod 11b are more and more deviated from the proximal end to the distal end from the central axis of the transport device 100b, and can be parallel to the central axis under the restraint of the retracting mechanism, the rod 21b and the hook-shaped rod 11b will be pushed out.
  • the wall of the tube is designed with a number of grooves to reduce the hardness of the push rod 21b and the hook rod 11b, making it easier to bend when restrained.
  • the groove direction of the groove 114b on the hook rod 11b is the same as the groove direction of the hook-shaped first slit 111b, and the groove direction of the groove 213b on the push-out rod 21b and the notch of the second slit 211b on the push-out rod 21b.
  • the opposite direction When the push-out rod 21b penetrates into the hook-shaped rod 11b, the direction of the notch of the groove 213b on the push-out rod 21b is opposite to the direction of the notch of the groove 114b on the hook-shaped rod 11b, which can improve the flexibility while avoiding both The grooves on the rods are scraped against each other. It can be understood that in other embodiments, the groove 114b on the hook rod 11b and the groove on the push rod 21b can also be disposed in the same direction.
  • the adjacent grooves 114b on the hook rod 11b are spaced apart by a distance 115b, preferably, the depth of each groove 114b on the hook rod 11b in the radial direction of the hook rod 11b and the first on the hook rod 11b
  • the depth of the slit 111b in the radial direction of the hook-shaped rod 11b is the same, and the depth of each groove 213b on the push-out rod 21b along the radial direction of the push-out rod 21b and the edge of the second slit 211b on the push-out rod 21b are along the push-out rod 21b.
  • the radial depth is the same. Since the plurality of grooves 114b on the hook rod 11b are cut from the hook rod 11b, The consistent depth of all the grooves on the same tube simplifies the process.
  • the separation distance between the adjacent grooves 114b can be set to a smaller and smaller form, due to the natural state.
  • the hook rod 11b is increasingly offset from the central axis of the delivery device 100b, so that when the retractable disk moves from the proximal end to the distal end of the delivery device 100b, the curved hook rod 11b is gradually bound into The state of the central axis of the conveying device 100b is substantially parallel, and in this process, the portion of the hook rod 11b closer to the distal end is deformed more.
  • the hook rod 11b When the distance between the proximal end and the distally adjacent groove 114b on the hook rod 11b becomes smaller and smaller, the hook rod 11b is more and more easily bent from the proximal end to the distal end, that is, the hook rod 11b It is more and more easily deformed from the proximal end to the distal end.
  • the 21b structure of the push rod is similar to the hook rod and will not be described here.
  • the hook-shaped rod 11b and the groove on the push-out rod 21b may also be arranged as a plurality of mutually spaced oblique slots (ie, the direction of the slot of the slot and the radial direction of the rod) The angle between them is an acute angle).
  • the slits of any shape can be cut on the tube wall of the hook rod 11b and the push rod 21b, as long as the material of the hook rod 11b and the push rod 21b can be reduced, and the hardness is lowered. It makes it easy to bend.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
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  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Reproductive Health (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un appareil de pose (100), comprenant un mécanisme de crochet (10) et un mécanisme d'éjection (20), le mécanisme d'éjection (20) étant mobile par rapport au mécanisme de crochet (10), de sorte qu'un corps de couvercle d'un levier de type crochet (11, 11a, 11b) du mécanisme de type crochet et une seconde rainure (211, 211a, 211b) d'un levier d'éjection (21, 21a, 21b) reçue dans le levier de type crochet (11, 11a, 11b) peuvent former un espace de réception pouvant être ouvert. Par rapport à l'état de la technique, l'appareil de pose (100) se connecte à un dispositif médical (200), lors de la pose du dispositif médical (200), au moyen de l'espace de réception pouvant être ouvert formé par l'extrémité distale du mécanisme de type crochet et l'extrémité distale du mécanisme d'éjection (20), et peut non seulement limiter axialement mais également limiter radialement le dispositif médical (200), ce qui permet d'améliorer la contrôlabilité et la sécurité de la pose.
PCT/CN2017/117296 2016-12-29 2017-12-19 Appareil de pose et système de pose WO2018121363A1 (fr)

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CN201611250328.4A CN108245292B (zh) 2016-12-29 2016-12-29 输送装置及输送系统

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