WO2018103662A1 - Système de transport d'implant - Google Patents

Système de transport d'implant Download PDF

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Publication number
WO2018103662A1
WO2018103662A1 PCT/CN2017/114809 CN2017114809W WO2018103662A1 WO 2018103662 A1 WO2018103662 A1 WO 2018103662A1 CN 2017114809 W CN2017114809 W CN 2017114809W WO 2018103662 A1 WO2018103662 A1 WO 2018103662A1
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WO
WIPO (PCT)
Prior art keywords
tube
inner sheath
core tube
sheath core
hooking
Prior art date
Application number
PCT/CN2017/114809
Other languages
English (en)
Chinese (zh)
Inventor
肖本好
王琴
李午阳
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 WO2018103662A1 publication Critical patent/WO2018103662A1/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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • 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
    • A61F2002/9534—Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents
    • 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
    • A61F2002/9665—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 with additional retaining means

Definitions

  • the present invention relates to implantable medical devices, and in particular to delivery systems for implants.
  • luminal stent intervention For diseases such as vascular stenosis, aneurysm and vascular dissection, luminal stent intervention has the advantages of less trauma, quick recovery, less complications, and better therapeutic effect.
  • the metal skeleton structure of the self-expanding stent lumen stent is usually made of Nitinol, and after the heat setting process, the lumen stent has the ability to restore its shape.
  • the tube of the delivery system of such a stent generally comprises an outer sheath tube and an inner sheath core tube pre-installed in the outer sheath tube.
  • the proximal end of the inner sheath core tube is thicker and the distal end is thinner.
  • the lumen bracket is received in the cavity between the outer sheath tube and the distal end portion of the inner sheath core tube, and the distal end of the stent and the inner sheath core tube are thicker.
  • the distal end face of the portion is in close contact with the inner sheath core tube for connecting the seeker (or tip) and receiving and passing the guide wire.
  • the blood vessel shape is bent and the lumen stent is also easily displaced. Will affect the subsequent release, and when the outer sheath is removed, the stent will be easily displaced, resulting in unsatisfactory release position, which will affect the therapeutic effect.
  • this delivery system still has the following defects: (1) during the delivery of the lumen stent, when the outer sheath tube and the sheath core tube together pass through the curved portion of the human lumen, the bending radius of the curved blood vessel is smaller.
  • the gap between the sheath core tube and the outer sheath tube is reduced; on the side of the curved radius of the curved blood vessel, the gap between the sheath core tube and the outer sheath tube is increased, and at this time, the rigid protrusion and the outer portion
  • the distance between the inner walls of the sheath is increased, the rigid protrusions are easily separated from the lumen stent, and the lumen stent may be separated from the protrusions, thereby causing the position of the lumen stent to be displaced in the outer sheath tube, affecting Subsequent release.
  • the lumen stent When the sheath core tube and the outer sheath tube reach the lesion site, when the operator withdraws the outer sheath tube and releases the lumen stent, the lumen stent may be completely released from the outer sheath tube quickly, and if the release position is not ideal, it cannot be Adjust the release position. (3) When the lumen stent is partially released from the outer sheath tube, if the release position of the lumen stent is found to be unsatisfactory, the distal position of the outer sheath tube needs to be adjusted, and the lumen stent may be sheathed during the adjustment process. The tube was completely released in advance.
  • the implant delivery system that secures the implant to the sheath core tube even within a curved vessel. Avoid offset between the implant and the inner sheath core. Moreover, the implant can be gradually released during the release process, avoiding the disadvantage of being unable to adjust the release position after the sudden release of the implant, and adjusting the release position of the release implant. During the procedure, avoid complete release of the implant in advance.
  • the present invention provides an delivery system for an implant, comprising an inner sheath tube extending through the inner sheath tube and extending distally from the inner sheath core tube of the inner sheath tube, movably sleeved outside the inner sheath tube And an outer sheath tube having a cavity between the inner sheath core tube and at least one hooking unit fixed to an outer surface of the inner sheath core tube.
  • the hooking unit includes at least two flexible hooks.
  • the hooking member includes a fixing portion connected to an outer surface of the inner sheath core tube, and a deformation portion connected to the fixing portion.
  • the free end of the deforming portion is bendable relative to the fixing portion and cooperates with the fixing portion to form a hook when being received in a cavity between the outer sheath tube and the inner sheath core tube.
  • the hook member hooks the implant, and the freedom of the hook member
  • the end has a tendency to expand radially outward along the inner sheath core tube, and the inner wall of the outer sheath tube inhibits the tendency of the free end to expand radially outward of the inner sheath core tube, thus
  • the hooks can limit the relative movement between the implant and the inner sheath core tube.
  • the hooking member When the outer sheath tube moves axially proximally relative to the inner sheath core tube, the hooking member is released from a cavity between the outer sheath tube and the inner sheath core tube, the outer sheath
  • the inner wall of the tube eliminates the tendency of the free end of the hook to expand radially outwardly of the inner sheath core tube, the deformed portion expanding radially outward of the inner sheath core tube And separating from the implant, the implant is released from the outer sheath.
  • the deformation portion has elasticity.
  • the extending direction of the deformation portion is opposite to the inner sheath core tube
  • the angle between the proximal to distal directions ranges from 0 to 180 degrees.
  • connection of the free end of each of the deformation portions is composed of
  • the diameter of the circumscribed circle of the polygon is less than 90% of the diameter of the circumcircle of the polygon formed by the line of the implant at the junction with each of the hooks before being compressed.
  • the circumscribed circle of the polygon composed of the line connecting the free ends of each of the deformation portions has a diameter ranging from 3 to 50 mm.
  • the deformation portion is along the axial direction of the inner sheath core tube
  • the length ranges from 3 to 50 mm.
  • the hooking unit includes 2 to 12 hooks, and the 2 to 12 hooks are symmetrically disposed about a central axis of the inner sheath core tube.
  • the hooking unit further includes a hollow tubular hoop member sleeved and fixed to an outer surface of the inner sheath core tube, the hooking member passing through the hoop member and the inner sheath The outer surfaces of the core tubes are connected.
  • the fixing portion is located between the fastening member and an outer surface of the inner sheath core tube, the fastening member restricting the fixing portion and an outer surface of the inner sheath core tube Relative movement between.
  • the fastening member has a blind hole in the axial direction, and the fixing portion of the hooking member is inserted into the blind hole and fixedly connected to the fastening member.
  • the fastening member has a through hole in the axial direction, and the fixing portion of the hooking member is axially penetrated through the through hole and fixedly connected to the fastening member.
  • the hoop member has a diameter in the range of 1 to 30 mm, and the hoop member has a length in the axial direction of the inner sheath core tube ranging from 2 to 10 mm.
  • the delivery system further includes a limiting member disposed between the hooking unit and the distal end of the inner sheath core tube, the limiting member being fixed to the inner sheath core tube The outer surface projects toward the axial direction away from the inner sheath core tube.
  • the hook has a U-shaped configuration of twin strands.
  • At least a portion of the free end of the deformation of the hook is heat set.
  • an angle between a plane in which at least a portion of the free end of the deformation portion of the hook portion is located and a plane in which the fixing portion is located ranges from 60 degrees to 120 degrees.
  • an angle between a plane in which at least a portion of the free end of the deformation portion of the hook portion is located and a plane in which the fixing portion is located is 90 degrees.
  • At least one receiving space for receiving the free end of the deformation portion is disposed on the outer surface of the tube of the fastening member.
  • the delivery system of the present invention provides a flexible hook on the inner sheath core tube instead of the rigid protrusion to constrain the lumen support, and has at least the following beneficial effects:
  • the flexible hook When the body of the delivery system loaded with the implant is delivered within the lumen of the body, the flexible hook is bent proximally through the end of the implant and is constrained to the inner sheath core tube and Between the outer sheath tubes and having a long length along the axial direction of the inner sheath core tube, the hook member is not detached from the implant even when passing through the relatively curved body lumen portion, avoiding the prior art rigid convexity.
  • the gap between the material and the inner wall of the outer sheath tube creates a risk of the implant falling off from the rigid protrusion.
  • the implant can be gradually released under the constraint of the outer sheath tube within the length of the flexible hook until all the flexible hooks are exposed, thereby avoiding the disadvantage that the release position cannot be adjusted after the implant is suddenly released.
  • the operator can withdraw the body and adjust the distal position of the tube.
  • the implant is fixed on the inner sheath core tube. And the relative movement between the implant and the outer sheath tube does not occur, effectively preventing the implant from being released in advance from the outer sheath tube.
  • the portion near the proximal end of the implant is still fixed to the inner sheath core tube by the hook unit.
  • the distal end of the outer sheath tube can be re-recovered into the cavity between the outer sheath tube and the inner sheath core tube by driving the outer sheath tube to move axially distally relative to the inner sheath core tube, and then the tube The body is withdrawn from the patient and replaced with an appropriately sized implant.
  • the delivery system includes a handle housing, a slider, a tube body, and a hooking unit, the tube body including an outer sheath tube, an inner sheath core tube, and an inner sheath tube;
  • Figure 2a is a cross-sectional view of the hook unit and the tube body of Figure 1 in a section parallel to the axial direction;
  • 2b is a schematic structural view of another embodiment of a tubular body
  • FIG. 3a to 3c are schematic views showing the structure of the hooking unit of FIG. 1.
  • the hooking unit includes three hooking members and a tightening member, wherein FIG. 3a is a front view of the hooking unit not received in the tubular body.
  • Figure 3b is a front view of the hooking unit housed in the pipe body, and
  • Figure 3c is a cross-sectional view of the hooking unit not received in the pipe body in a section parallel to the axial direction;
  • FIG. 4a to 4c are schematic structural views of the hooking member of Fig. 3a, wherein Fig. 4a is a front view, Fig. 4b is a schematic view of the hooking member at another angle, and Fig. 4c is a side view;
  • FIG. 5a and 5b are schematic structural views of another embodiment of a hooking unit, wherein FIG. 5a is a front view and FIG. 5b is a side view;
  • Figure 5c is a cross-sectional view of another embodiment of the hooking unit in a section parallel to the axial direction;
  • FIG. 5d and 5e are schematic views of another embodiment of the hooking unit and the tube body of Fig. 1, wherein Fig. 5d is a cross-sectional view in a section parallel to the axial direction, and Fig. 5e is a view in Fig. 5d Partial enlarged view;
  • Figure 6 is a cross-sectional view of the hooking unit, the tube body and the lumen bracket in a section parallel to the axial direction when the hooking unit of Figure 1 is fixed to the inner sheath core tube;
  • Figure 7 is a schematic view of the hooking unit of Figure 1 no longer fixing the lumen stent to the inner sheath core tube;
  • FIG. 8a and 8b are schematic views of the process of the tube delivery lumen stent of Fig. 1, wherein Fig. 8a is a schematic view of the process of releasing the lumen stent portion from the outer sheath tube after reaching the lesion site, and Fig. 8b is an adjustment tube body. Schematic diagram of the process at the remote location;
  • FIG. 9a and FIG. 9b are schematic diagrams showing the process of recovering the lumen stent to the outer sheath tube of FIG. 1.
  • FIG. 9a is a schematic view showing the release of the lumen stent portion from the outer sheath tube
  • FIG. 9b is a schematic diagram of the lumen stent recovery to a schematic diagram of the process in the outer sheath;
  • 10a to 10c are schematic views of a hooking unit in a transport system according to a second embodiment, the transport system includes a tube body, a hooking unit, a handle housing and a slider, and the hooking unit includes three hooking members, wherein 10a is a front view of the hooking unit not received in the pipe body; FIG. 10b is a front view of a hooking member in FIG. 10a, and FIG. 10c is a front view of the hooking member in FIG. 10a received in the pipe body;
  • FIG. 10d to 10g are schematic views of another embodiment of the hooking unit, wherein FIG. 10d is a front view of the hooking unit not received in the tube body, and FIG. 10e is a hooking unit of FIG. 10d received in the tube.
  • Figure 10f is a schematic view of the hooking unit when the lumen stent is fixed on the inner sheath core tube;
  • Figure 10g is a schematic view of the lumen stent released from the outer sheath tube;
  • Figure 10h is a front elevational view of another embodiment of the hooking unit.
  • Figure 11 is a cross-sectional view of another embodiment of the hook unit in a section parallel to the axial direction;
  • FIG. 12a and 12b are schematic views of another embodiment of a hooking unit, wherein FIG. 12a is a front view and FIG. 12b is a side view;
  • FIG. 13a and 13b are schematic views of a transport system provided by a third embodiment.
  • the transport system includes a tube body, a hooking unit and a limiting member.
  • FIG. 13a is a front view
  • FIG. 13b is a tube body, a hooking unit and a limit. a cross-sectional view of a portion of the bit member in a section parallel to the axial direction;
  • FIG. 14a and 14b are schematic structural views of a transport system according to a fourth embodiment.
  • the transport system includes a handle housing, a slider, a tube body and a hooking unit.
  • the hooking unit includes a hooking member, wherein FIG. 14a is a tube body and a hook.
  • Hanging unit main view, FIG. 14b is a cross-sectional view of a portion of the tube body and the hooking unit of FIG. 14a in a section parallel to the axial direction;
  • FIG. 15a to 15c are schematic structural views of a conveying system according to a fifth embodiment.
  • the conveying system includes a handle housing, a slider, a tube body and three hooking units.
  • FIG. 15a is a front view of the tube body and the hooking unit.
  • Figure 15b is a cross-sectional view of the tube body and the hooking unit in a section parallel to the axial direction, and
  • Figure 15c is a schematic view showing a partial release of the lumen bracket from the tube body in Figure 15b;
  • Figure 16 is a schematic view showing the structure of a conveying system including a plurality of hooking units.
  • an element when referred to as being “fixed” to another element, it can be directly on the other element or the element can be present. When an element is considered to be “connected” to another element, it can be directly connected to the other element or.
  • the end near the operator is usually referred to as the proximal end, and the end far from the operator is referred to as the distal end.
  • proximal and distal are defined herein as a common term in the field of interventional medicine. Specifically, in the field of interventional medicine, “distal” refers to the end away from the operator during the surgical procedure, and “proximal” refers to the end that is close to the operator during the surgical procedure. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning meaning The terminology used in the description is for the purpose of describing the particular embodiments, and is not intended to limit the invention.
  • a delivery system 100 is provided in the first embodiment for delivering an implant to a lesion in a lumen of a human body.
  • the delivery system 100 includes a tubular body 10, a hooking unit 20, and a handle including a handle housing 30 and a slider 33.
  • the handle housing 30 includes a first housing 31 and a second housing (not shown) that are axially symmetrically disposed.
  • the number of the sliders 33 is two.
  • the two sliders 33 are respectively disposed on the first housing 31 and the second housing of the handle housing 30 and are symmetrical to each other.
  • the implant is a lumen stent 200.
  • the tube body 10 includes a hollow inner sheath tube 11 extending axially through the handle housing 30, a hollow inner sheath core tube 13 extending through the inner sheath tube 11 and distally extending from the inner sheath tube 11, and movably sleeved on the inner sheath tube 11
  • An outer sheath tube 12 having a cavity between the outer and inner sheath core tubes 13 and a hollow tip 14 disposed at the distal end of the inner sheath core tube 13 and impervious to X-rays.
  • the compressed lumen stent 200 is loaded into the cavity between the distal end of the inner sheath core tube 13 and the distal end of the outer sheath tube 12 and is in frictional contact with the outer surface of the inner sheath core tube 13.
  • the outer sheath tube 12 can be moved in the axial direction relative to the inner sheath core tube 13 by the slider 33 on the operating handle, and the outer sheath tube 12 can be withdrawn proximally, eventually causing the lumen holder 200 from the outer sheath tube 12 Released among them.
  • the handle can be of other construction as long as the handle can drive the outer sheath tube 12 to move axially relative to the inner sheath core tube 13.
  • the delivery system 100 further includes a fluid guide assembly 15 that is fixedly mounted to the handle housing 30.
  • the liquid guiding assembly 15 includes a hollow hose 151 for conveying a rinsing liquid or a contrast agent, a connecting head 152 connecting the hose 151 and the inner sheath tube 11, and a three-way valve 153 connecting the hose 151 at one end.
  • the lumen of the hose 151 of the fluid guiding assembly 15 communicates with the cavity between the outer sheath tube 12 and the inner sheath tube 11.
  • the syringe Before the surgery, the syringe is connected to the three-way valve 153 to introduce the rinse liquid to flush the outside of the inner sheath tube 11 or to discharge the air between the outer sheath tube 12 and the inner sheath tube 11.
  • the syringe can also be connected to the three-way valve 153 before or during surgery, and the contrast agent can be injected for contrast.
  • the inner sheath tube 11 extends axially through the proximal end face and the distal end face of the handle housing 30.
  • the inner sheath tube 11 is fixedly coupled to the inner sheath core tube 13 located inside the inner sheath tube 11.
  • the manner of fixing the connection may be a technical means commonly used in the art such as welding, bonding, sewing, hot-melting or screwing, and will not be described in detail herein.
  • the inner sheath tube 11 is made of a polymer material having toughness. It can be understood that in other embodiments, the inner sheath tube 11 can also be made of a metal material.
  • the inner sheath tube 11 can also be a combination of a tube body made of a polymer material and a tube body made of a metal material.
  • the tube portion of the inner sheath tube 11 near the distal end is housed in the outer sheath tube 12, and is made of a tough polymer material to facilitate the passage of the inner sheath tube 11 in the curved human lumen.
  • the tube portion of the inner sheath tube 11 near the proximal end is located inside the handle housing 30 and is made of a metal material to improve the support of the proximal end of the inner sheath tube 11.
  • the tubular body 10 may not include the inner sheath tube 11.
  • the tube body 10 includes a hollow inner sheath core tube 13 axially penetrating the handle housing 30, an outer sheath tube 12 movably sleeved outside the inner sheath core tube 13, and a sheath disposed at the inner sheath The distal end of the core tube 13 and the X-ray opaque hollow Tip head 14.
  • the inner sheath core tube 13 includes a first tube body 131 near the proximal end and a second tube body 132 axially connected to the distal end of the first tube body 131, and the diameter of the first tube body 131 is larger than that of the second tube body 132 diameter.
  • the compressed lumen stent 200 can be received in the cavity between the outer sheath tube 12 and the second tubular body 132 and in frictional contact with the second tubular body 132.
  • the hooking unit 20 is disposed on the second tubular body 132 and detachably coupled to the lumen support 200 (see FIG. 2a). It can be understood that the first tube body 131 and the second tube body 132 can be made of different materials.
  • the first tube body 131 is made of a tough polymer material
  • the second tube body 132 is made of a metal material to ensure distal flexibility and proximal support of the inner sheath core tube 13.
  • the first tube body 131 and the second tube body 132 can also be made of the same material.
  • the first tube body 131 and the second tube body 132 are each made of a polymer material having toughness.
  • the inner sheath core tube 13 may also include a third tube (not shown). The third pipe body may be sleeved on the pipe body portion of the first pipe body 131 near the proximal end.
  • the third tube body may also be axially connected to the proximal end of the first tube body 131.
  • the hardness of the third pipe body is higher than the hardness of the first pipe body 131 to enhance the straightness and improve the proximal support of the inner sheath core pipe 13.
  • the outer sheath tube 12 is sleeved on the outer part of the inner sheath tube 11 and the inner sheath core tube 13, and can be driven by the handle relative to the inner sheath tube 11 and the inner sheath core tube 13 at the axis.
  • the side wall of the outer sheath tube 12 adjacent to the proximal end is fixedly connected with the slider 33, whereby when the drag slider 33 is advanced distally or retracted proximally, the outer sheath tube 12 can be driven to perform the same direction. Axial movement.
  • the outer sheath tube 12 is made of a tough polymer material or a metal material. It can be understood that, in other embodiments, a stiffer reinforcing tube (not shown) may be placed on the outer side of the outer sheath tube 12 near the proximal end, or a stiffer tube and outer sheath tube having a higher hardness may be placed. The proximal ends of 12 are axially connected. The reinforcing tube is also provided with a chute, whereby the firmness of the joint of the outer sheath tube 12 with the slider 33 can be enhanced, and the passage of the outer sheath tube 12 in the handle housing 30 can be improved.
  • the tube body of the inner sheath core tube 13 near the proximal end is housed in the inner sheath tube 11.
  • the tube body of the inner sheath tube 13 housed in the inner sheath tube 11 and the inner sheath tube 11 are fixed together by a common connection method in the field such as welding, bonding, sewing, hot-melting or screwing to improve the inner sheath core.
  • the compressed lumen stent 200 is loaded into a cavity formed between the inner sheath core tube 13 and the outer sheath tube 12 which is not surrounded by the inner sheath tube 11.
  • the distal end of the inner sheath core tube 13 is connected to a radiopaque hollow Tip head 14 which may be connected by injection molding or bonding.
  • the lumen of the inner sheath core tube 13 communicates with the lumen of the Tip head 14.
  • the inner sheath core tube 13 and the inner cavity of the Tip head 14 are for receiving and passing through a guide wire (not shown).
  • the hooking unit 20 is disposed on the outer surface of the tubular body in which the inner sheath core tube 13 is not wrapped by the inner sheath tube 11.
  • the hooking unit 20 includes a hollow tubular fastening member 21 fixed to the inner sheath core tube 11 and three flexible hook members 22 connected to the fastening member 21.
  • the three flexible hooks 22 are symmetrically disposed about the central axis of the inner sheath core tube 13. Since the outer sheath tube 12 is axially movable relative to the inner sheath core tube 13, the free end of the flexible hook member 22 is movably received in the cavity formed between the outer sheath tube 12 and the inner sheath core tube 13.
  • the hooking member 22 has a tendency to expand outward in the radial direction of the inner sheath core tube 13, and the inner wall of the outer sheath tube 12 suppresses the tendency of the hooking member 22 to expand outward in the radial direction of the inner sheath core tube 13, so that the hook The pendant 22 remains hooked.
  • the hooks 22 can limit the relative movement between the lumen support 200 and the inner sheath core tube 13.
  • the hooking unit 20 When the outer sheath tube 12 is axially moved relative to the inner sheath core tube 13, the hooking unit 20 is released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13, and the inner wall of the outer sheath tube 12 is hooked.
  • the restraining effect of the tendency of the hanger 22 to expand outward in the radial direction of the inner sheath core tube 13 disappears, and the hook member 22 is deployed outward in the radial direction of the inner sheath core tube 13 to return to the naturally unfolded state shown in Fig. 3a, and The lumen stent 200 is separated. That is, the hooking unit 20 is released from the hooking of the lumen holder 200.
  • the hooking member 22 includes a fixing portion 221 connected to the outer surface of the inner sheath core tube 13, and is connected to the fixing portion 221. Deformation section 222.
  • the fixing portion 221 is provided between the tightening member 21 and the outer surface of the inner sheath core tube 13. That is, the fastening member 21 is sleeved on the outside of the fixing portion 221 and restricts the movement of the fixing portion 221.
  • one end of the deforming portion 222 is connected to the fixing portion 221, and the other end is a free end.
  • the free end of the deformed portion 222 extends in a direction away from the axial direction of the inner sheath core tube 13. That is, the deformed portion 222 has a free end that extends in a direction away from the axial direction of the inner sheath core tube 13.
  • the free end of the deformed portion 222 can be bent relative to the fixed portion 221 .
  • the deformation portion 222 is made of a flexible material, preferably made of a material having elasticity.
  • the deformation portion 222 is made of a nickel-titanium alloy having a shape memory function.
  • the fixing portion 221 is also made of a nickel-titanium alloy, that is, the entire hook member 22 is made of a nitinol material by integral molding.
  • the length L1 of the deformation portion 222 along the axial direction of the inner sheath core tube 13 ranges from 3 to 50. Millimeter.
  • the detachable connection between the deformed portion 222 and the lumen support 200 is more reliable, and the deformed portion 222 is neither scratched after being released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13.
  • the blood vessels also do not affect the separation of the deformation portion 222 from the lumen 200.
  • the length L1 of the deformed portion 222 along the axial direction of the inner sheath core tube 13 is 6 mm.
  • the length L2 of the fixing portion 221 in the axial direction of the inner sheath core tube 13 ranges from 2 to 10 mm. Therefore, the fixing portion 221 does not affect the flexibility of the tube body 10, facilitates the passage of the tube body 10 in the human body to distort the blood vessel, and does not reduce the connection strength between the fixing portion 221 and the fastening member 21, and thus does not Affects the connection reliability of the lumen stent 200 and the inner sheath core tube 13.
  • the length L2 of the fixing portion 221 in the axial direction of the inner sheath core tube 13 is 6 mm.
  • the angle between the extending direction of the deforming portion 222 and the direction from the proximal end to the distal end of the inner sheath core tube 13 The range is from 0 to 180 degrees, preferably less than or equal to 90 degrees. In the present embodiment, the angle ⁇ between the extending direction of the deformed portion 222 and the direction from the proximal end to the distal end of the fixed portion 221 ranges from 0 degrees to 180 degrees.
  • the connection reliability of the detachable connection between the lumen holder 200 and the deformation portion 222 can be ensured, and after the lumen holder 200 is released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13,
  • the dissociation between the deformed portion 222 and the lumen support 200 is separated.
  • the angle between the extending direction of the deforming portion 222 and the direction from the proximal end to the distal end of the inner sheath core tube 13 and the extending direction of the deforming portion 222 and the proximal end to the distal end of the fixing portion 221 The angle ⁇ between the directions is the same, both being 90 degrees.
  • the diameter D of the polygonal circumscribed circle formed by the line connecting the free ends of each deformation portion 222 is smaller than
  • the lumen support 200 is 90% of the diameter of the circumscribed circle of the polygon formed by the line connecting the hooks 22 before being compressed.
  • the diameter of the circumscribed circle of the polygon formed by the line connecting the free ends of each deformation portion 222 is 3 Up to 50 mm.
  • the connection between the deformed portion 222 and the lumen 200 is more reliable, and the deformed portion 222 is released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13, and the blood vessel is not scratched. Nor does it affect the separation of the deformation portion 222 from the lumen support 200.
  • the lumen support 200 has a diameter of 12 mm.
  • the diameter of the polygonal circumcircle composed of the line connecting the free ends of each of the deformed portions 222 is smaller than the inner diameter of the outer sheath tube 12.
  • the diameter of the circumscribed circle of the polygon formed by the line connecting the free ends of each deformation portion 222 is 3.5 mm. .
  • the hollow tubular fastening member 21 is sleeved on the outer surface of the inner sheath core tube 13.
  • the fastening member 21 may be made of a polymer material or a metal material and fixedly connected to the outer surface of the inner sheath core tube 13 by adhesion, interference fit, stitching, hot melt or welding (for example, laser spot welding).
  • the fastening member 21 is fixed to the outer surface of the inner sheath core tube 13 by adhesion.
  • the fixing portion 221 of the hooking member 22 is located between the tightening member 21 and the outer surface of the inner sheath core tube 13.
  • the tightening member 21 limits the relative movement between the fixed portion 221 and the outer surface of the inner sheath core tube 13.
  • the inner diameter of the tightening member 21 is greater than or equal to the outer diameter of the inner sheath core tube 13.
  • the diameter of the hoop member 21 is smaller than the inner diameter of the outer sheath tube 12.
  • the diameter of the hoop member ranges from 1 to 30 mm, and the length of the hoop member 21 in the axial direction of the inner sheath core tube 13 is larger than the length of the fixed portion 221 in the axial direction of the inner sheath core tube 13.
  • the length of the hoop member 21 in the axial direction of the inner sheath core tube 13 ranges from 2 to 10 mm. In the present embodiment, the length of the hoop member 21 along the axial direction of the inner sheath core tube 13 is 5 mm.
  • the fastening member 21 and the fixing portion 221 of the hooking member 22 can have other connection manners.
  • the clamping member 21 is a sleeve 210 having a certain wall thickness, and the tube wall of the sleeve 210 has a blind hole 211 in the axial direction.
  • the length of the tightening member 21 in the axial direction of the inner sheath core tube 13 is larger than the length of the fixing portion 221 in the axial direction of the inner sheath core tube 13.
  • the fastening member 21 may also be a sleeve 210 having a certain wall thickness, and the tube wall of the sleeve 210 has a through hole 212 in the axial direction.
  • the length of the tightening member 21 in the axial direction of the inner sheath core tube 13 is smaller than the length of the fixing portion 221 in the axial direction of the inner sheath core tube 13.
  • the ball 2211 is formed by laser spot welding of the fixing portion 221 away from the end of the deforming portion 222, and the diameter of the ball 2211 is larger than the diameter of the through hole 212 to ensure the fixing portion. 221 does not fall off the self-tightening member 21.
  • the hoop member 21 can also be made of a resilient material.
  • the hoop member 21 can be a sleeve of resilient material.
  • the fastening member 21 is sleeved on the outer surface of the inner sheath core tube 13.
  • the fixing portion 221 of the hooking member 22 is provided between the fastening member 21 and the inner sheath core tube 13.
  • the portion of the inner sheath tube 11 near the distal end and the inner sheath core tube 13 have a space for receiving the tightening member 21.
  • the portion near the proximal end of the hoop member 21 is provided in the gap between the inner sheath tube 11 and the inner sheath core tube 13.
  • the tightening member 21 holds the inner sheath core tube 13 to restrict the movement of the fixing portion 221 of the hooking member 22.
  • the distal end surface of the tightening member 21 is flush with the distal end surface of the inner sheath tube 11, and the fixing portion 221 of the hooking member 22 can be better fixed.
  • the hoop member 21 may also be a hollow sleeve made of a heat shrinkable material.
  • the fixing portion 221 of the hooking member 22 is provided between the fastening member 21 and the outer surface of the inner sheath core tube 13.
  • the lumen stent 200 needs to be loaded into the body 10 of the delivery system 100 prior to implantation in the patient, and then delivered by the delivery system 100 to the lesion in the patient.
  • the loading process of the lumen stent 200 is as follows: the lumen stent 200 is placed over the outer surface of the inner sheath core tube 13, and the deformed portion 222 of the hook member 22 is hooked to the hollow of the proximal end of the lumen stent 200 ( That is, the skeleton at the crest is such that the lumen stent 200 is fixed over the outer surface of the inner sheath core tube 13.
  • the outer sheath tube 12 is driven to move axially distally relative to the inner sheath core tube 13 by pushing the slider 33 distally.
  • the lumen stent 200 is gradually compressed from the proximal end to the distal end and received in a cavity between the outer sheath tube 12 and the inner sheath core tube 13.
  • the slider 33 is further pushed toward the distal end, and the deformed portion 222 of the hooking member 22 is bent relative to the fixing portion 221 and formed with the fixing portion 221.
  • the hook is received in a cavity between the outer sheath tube 12 and the inner sheath core tube 13.
  • the slider 33 is continued to be pushed distally until the entire lumen holder 200 is received in the cavity between the outer sheath tube 12 and the inner sheath core tube 13.
  • the lumen stent 200 is fixed to the inner sheath core tube 13 by the hook unit 20, and the hook unit 20 limits the lumen bracket 200. Relative movement with the inner sheath core tube 13. And since the free end of the deformed portion 222 has a tendency to expand outward in the radial direction of the inner sheath core tube 13, the inner wall of the outer sheath tube 12 suppresses the tendency of the free end to expand outward in the radial direction of the inner sheath core tube 13, The hooks 22 remain hook-shaped.
  • the outer sheath tube 12 is driven relative to the distal end by withdrawing the slider 33 (see FIG. 1).
  • the inner sheath core tube 13 moves axially toward the proximal end.
  • the inner wall of the outer sheath tube 12 has a tendency to suppress the tendency of the free end of the deformed portion 222 to expand outward in the radial direction of the inner sheath core tube 13.
  • the deformation portion 222 made of an elastic material is released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13.
  • the deformed portion 222 is restored to the deployed state due to its own elasticity, and is automatically separated from the hooked lumen bracket 200.
  • the lumen stent 200 is no longer connected to the inner sheath core tube 13, and when the outer sheath tube 12 continues to move axially proximally relative to the inner sheath core tube 13, the lumen stent 200 is released from the outer sheath tube 12, and Rely on its own superelastic expansion and attach to the vessel wall.
  • the entire tubular body 10 can be directly retracted, and the position of the distal end of the tubular body 10 can be adjusted, and With the aid of digital imaging, it is observed through the development mark on the lumen stent 200 until the distal end of the tubular body 10 is adjusted to a more desirable release position.
  • the lumen support 200 is always fixed by the hook unit 20 due to the suppression of the tendency of the inner wall of the outer sheath tube 12 to the free end of the deformation portion 222 along the radially outward direction of the inner sheath core tube 13.
  • the tube body 10 On the sheath core tube 13, at this time, the tube body 10 is withdrawn, and the relative movement between the outer sheath tube 12 and the lumen holder 200 does not occur, thereby avoiding the relative movement between the outer sheath tube 12 and the lumen holder 200, resulting in the tube.
  • the cavity holder 200 is released in advance.
  • the use process of the delivery system 100 provided by this embodiment includes the following steps:
  • the first step percutaneous puncture into the guide wire to the lesion
  • the second step transporting the tube body 10 pre-installed with the lumen stent 200 along the guide wire to the lesion;
  • the third step keeping the position of the handle housing 30 unchanged, the outer sheath tube 12 connected to the slider 33 is driven to move proximally by the retracting slider 33. Thereby, the outer sheath tube 12 moves axially relative to the inner sheath core tube 13 and the lumen holder 200, and the lumen holder 200 is gradually released from the outer sheath tube 12. With the aid of medical imaging, it is evaluated whether the initial release position of the lumen stent 200 meets the clinical requirements by the development marker on the lumen stent 200.
  • the fourth step if the initial release position of the lumen stent 200 is ideal, the slider 33 can be continuously withdrawn to the proximal end, and the outer sheath tube 12 is driven to move axially relative to the inner sheath core tube 13 until the lumen stent 200 is completely released from the outer sheath tube 12.
  • Step 5 If the initial release position of the lumen support 200 is not satisfactory, the outer sheath tube 12 can be stopped, the relative position of the slider 33 and the handle housing 30 can be kept unchanged, the entire tube 10 can be retracted, and the tube body can be adjusted. 10 remote location.
  • the position of the distal end of the tubular body 10 since the lumen stent 200 is fixed to the inner sheath core tube 13 by the hooking unit 20, between the lumen stent 200 and the outer sheath tube 12 and the inner sheath core tube 13 No relative movement occurs, effectively preventing the lumen stent 200 from being released early from the outer sheath tube 12.
  • the sixth step when the distal end of the tubular body 10 is adjusted to a more desirable release position, the slider 33 on the handle housing 30 is again withdrawn, and the outer sheath tube 12 is driven to move axially proximally relative to the inner sheath core tube 13.
  • the hooking member 22 is released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13
  • the deformed portion 222 of the hooking member 22 is restored to its natural unfolded state due to its elasticity, and is automatically separated from the hooked lumen bracket 200.
  • the lumen stent 200 is no longer connected to the inner sheath core tube 13.
  • the lumen stent 200 is completely released from the outer sheath tube 12, since the lumen stent 200 has superelasticity, the stent can be naturally inflated and attached to the lesion. Vascular wall.
  • Step 7 Keep the position of the slider 33 unchanged, and then withdraw the handle housing 30 to drive the inner sheath core tube 13 to move proximally relative to the outer sheath tube 12. After the hooking member 22 of the outer surface of the inner sheath core tube 13 is received in the outer sheath tube 12, the entire delivery system 100 is withdrawn and the tube body 10 is withdrawn from the patient.
  • the delivery system provided by this embodiment has at least the following beneficial effects:
  • the inner wall of the outer sheath tube has an inhibitory effect on the unfolding tendency of the free end of the hooking unit, even when passing through a relatively curved body lumen portion
  • the hooking member is also not detached from the lumen bracket, which avoids the gap between the rigid protrusion of the prior art and the inner wall of the outer sheath tube, resulting in the risk of the lumen bracket falling off from the rigid protrusion.
  • the lumen stent is fixed on the inner sheath core tube by the hooking unit, and the lumen stent can be gradually released from the outer sheath tube, thereby avoiding the disadvantage that the release position cannot be adjusted after the lumen stent is suddenly released.
  • the operator can withdraw the tubular body and adjust the distal position of the tubular body.
  • the lumen stent is fixed on the inner sheath core tube. And the relative movement between the lumen stent and the outer sheath tube does not occur, effectively preventing the lumen stent from being released in advance from the outer sheath tube.
  • each of the hooks has a U-shaped structure composed of double strands.
  • the hooking unit comprises a hollow tubular fastening member and three hooking members connected to the fastening member.
  • the hook has a fixing portion connected to the fastening member and a deformation portion connected to the fixing portion.
  • Each hook consists of two straight rods and a circular rod connected between the two straight rods.
  • the radial distance H between the two straight rods ranges from 0.05 to 10 mm.
  • the reliability of the detachable connection between the lumen bracket and the hooking member is not reduced, and the automatic disengagement separation between the lumen bracket and the hooking member when the lumen stent is released is not affected.
  • the radial distance H between the two straight rods is 3 mm.
  • the central angle R of the circular arc rod ranges from 90 degrees to 180 degrees.
  • the central angle R is defined as the angle between the center of the arcuate rod and the two lines between the intersection of the two straight rods and the circular rod.
  • the hooking member can be flexible, bendable, and can be, for example, a wire.
  • the hooking member can also be made of a resilient material.
  • the hooking member is woven from nickel-titanium wire.
  • Each hook can be individually woven.
  • a hook having a U-shaped structure is woven on the woven mold bar each time using a nickel-titanium wire.
  • a total of three hooks are woven and heat-set separately. Three separate hooks are then placed on the outer surface of the inner sheath core tube and symmetrically disposed about the central axis of the inner sheath core tube.
  • the tightening member is sleeved on the outer surface of the inner sheath core tube, and the straight rod of the hook member is restrained between the inner surface of the tight band member and the outer surface of the inner sheath core tube to limit the hooking member and the inner sheath core Relative movement between tubes.
  • the three hooks may also be woven from the same nickel titanium wire (see Figure 10c).
  • the weaving method is as follows: three hooks having a U-shaped structure are sequentially woven on the woven mold bar using the same nickel-titanium wire, and the distal end of one straight rod of the first hooking member and one of the third hooking member are respectively The distal end of the straight rod is connected by common means such as hinge, welding, bonding, etc., and then subjected to high-temperature heat setting treatment to obtain three hook pieces connected to each other.
  • the nickel-titanium wire used in the weaving of the hooks has a wire diameter ranging from 0.05 mm to 2 mm.
  • the wire diameter of the nickel-titanium wire is related to the diameter of the lumen stent.
  • a nickel-titanium wire having a wire diameter of 0.15 mm is used to woven a hook.
  • the heat setting process can also be performed such that at least a portion of the free end of the deformation portion of the hook has a certain angle with the plane where the fixed portion is located, and the angle range is 60 degrees to 120 degrees, preferably 90 degrees.
  • the angle between the plane where the circular rod is located and the plane where the two straight rods are located is 90 degrees.
  • Figure 10f shows the state in which the hooking unit of the embodiment is housed in the outer sheath tube: the free end of the hooking member is bent toward the proximal end, and the arcuate rod of the hooking member is attached to the proximal end face of the tightening member. .
  • the circular arc rod of the hooking member is not only restricted by the inner wall of the outer sheath tube, but also the radial movement of the circular arc rod along the conveying system, and is also close to the axial end of the circular rod along the axial direction of the conveying system. The limit of the end-to-end movement.
  • FIG 10g shows the state in which the delivery system reaches the lesion and the lumen stent is fully released.
  • the outer sheath tube is retracted from the distal end to the proximal end relative to the inner sheath core tube, and the inner wall of the outer sheath tube disappears in the radial direction of the hooking member, and the deformation portion of the hooking member is along the stent diameter under the action of elasticity or external force.
  • the direction is reversed away from the inner sheath core tube, thereby releasing the connection with the lumen stent, and the lumen stent is attached to the stent under the self-expansion force to complete the release.
  • At least one receiving space for receiving the free end of the deformation portion may be disposed on the outer surface of the outer surface of the tubular member.
  • a plurality of grooves are provided on the outer surface of the tubular body of the hollow tubular hoop member near the proximal end.
  • the volume of each groove is equal to or slightly larger than the volume of one arc bar. Therefore, each groove can correspondingly accommodate a heat-set arcuate rod.
  • the arcuate rod fits into the recess, but is not caught by the recess or affects the release of the lumen bracket.
  • the hooks may also be cut from a nickel-titanium tube (see Figure 11).
  • the wall thickness of the nickel-titanium tube ranges from 0.05 mm to 2 mm.
  • Each of the hooks can be individually cut by a nickel-titanium tube, or a plurality of hooks can be cut at a time by the same nickel-titanium tube.
  • the fixing portion and the deformation portion of each hooking piece may be integrally cut by a nickel-titanium tube and then heat-set.
  • the fixing portion and the deforming portion of each of the hooking members may be separately cut and heat-set by a nickel-titanium tube, and then the fixing portion and the deforming portion may be fixedly connected by welding or bonding.
  • the fixing portion and the deformation portion of the hooking member may be made of the same material or different materials, and the deformation portion may be detachably connected to the lumen bracket as long as the deformation portion is made of a material having elasticity.
  • the hooking member may further have other shapes such as an L shape, an S shape or a V shape, or be a strip or a sheet as long as the deformation portion is made of a material having elasticity, that is, The purpose of detachable connection to the lumen stent can be achieved.
  • each of the hooking units may include only two hooks. It will be appreciated that in other embodiments, each of the hooking units may also include a greater number of hooks to increase the secure reliability of the hooking unit to the lumen support. However, in order for the diameter of the storage body to pass smoothly through the curved body lumen, the number of hooks should be less than or equal to twelve.
  • each hooking unit includes four hooking members, and four hooking members surround the inner sheath core tube. The center axis is symmetrically set.
  • the delivery system includes a tubular body 40, a handle housing 46, a slider 47, and a hooking unit 50.
  • the tube body 40 includes an inner sheath tube 41, an outer sheath tube 42, an inner sheath core tube 43, and a Tip head 44.
  • the stopper 45 is provided on the outer surface of the inner sheath core tube 43.
  • the stopper 45 is protruded from the outer surface of the inner sheath core tube 43 in the axial direction away from the inner sheath core tube 43.
  • the stopper 45 is fixed to the outer surface of the inner sheath core tube 43 near the distal end, and is closer to the distal end of the inner sheath core tube 43 than the hook unit 50.
  • the outer sheath core tube 43 is provided with a stopper 45 which is convex from the outer surface of the inner sheath core tube 43 in the axial direction away from the inner sheath core tube 43.
  • the limiting member 45 abuts against the proximal end surface or the proximal end hollow of the lumen stent 200, preventing the lumen stent 200 from being inwardly directed to the inner sheath core tube 43 with respect to the inner sheath core tube 43.
  • the near end moves.
  • the number of the limiting members 45 may be multiple.
  • the plurality of stoppers 45 are evenly or unevenly spaced along the axial direction of the inner sheath core tube 43.
  • the limiting member 45 can be a shape protrusion, a tapered protrusion or a spherical protrusion or the like, or a tube that is sleeved on the surface of the inner sheath core tube 43.
  • the proximal end face or hollow of the abutment lumen stent 200 can also be achieved to prevent the lumen stent 200 from moving proximally relative to the inner sheath core tube 43.
  • the delivery system provided in this embodiment has at least the following beneficial effects:
  • the lumen stent is fixed to the inner sheath core tube by the hooking unit, and the lumen stent can be gradually released from the outer sheath tube.
  • the limiting member of the delivery system is disposed on the outer surface of the inner sheath core tube near the distal end, so that when the outer sheath tube moves axially relative to the inner sheath core tube, even if the lumen bracket is external Friction between the inner walls of the sheath does not cause the lumen stent to move proximally, thereby reducing the possibility of lumen stent accumulation and reducing the release resistance of the lumen stent.
  • the structure of the lumen stent delivery system provided in this embodiment is substantially the same as that of the lumen stent delivery system 100 provided in the first embodiment. The difference is that, in this embodiment, the position of the hooking unit on the tube body of the inner sheath core tube is different from the position of the hook unit of the first embodiment on the tube body of the inner sheath core tube.
  • the conveying system comprises a pipe body 60, a hooking unit 70, a handle casing (not shown) and a slider (not shown).
  • the tubular body 60 includes an inner sheath tube 61, an outer sheath tube 62, an inner sheath core tube 63, and a Tip head 64.
  • the hooking unit 70 is provided on the outer surface of the tube of the inner sheath core tube 63 near the distal end.
  • the hooking unit 70 includes a tightening member 71 and a hooking member 72. Referring to Figure 14b, when the hook 72 is received in the cavity between the outer sheath 62 and the inner sheath core 63, the free end of the hook 72 is bent toward the distal end and directed toward the distal end. Thus, when the lumen stent 200 is loaded into the cavity between the outer sheath tube 62 and the inner sheath core tube 63, the hook 72 hooks the distal end of the lumen stent 200.
  • the hook member 72 hooks the lumen bracket 200 near the distal hollow, preventing the lumen bracket 200 from approaching the proximal end of the inner sheath core tube 63. Move or stack.
  • the delivery system provided in this embodiment has at least the following beneficial effects:
  • the hooking unit of the delivery system is disposed on the outer surface of the inner sheath core tube near the distal end, so that when the outer sheath tube moves axially relative to the inner sheath core tube, even if the lumen bracket and the outer sheath tube Friction between the walls does not cause the lumen stent to move proximally, thereby reducing the possibility of lumen stent accumulation and reducing the release resistance of the lumen stent.
  • the structure of the lumen stent delivery system provided in this embodiment is substantially the same as that of the lumen stent delivery system 100 provided in the first embodiment. The difference is that, in the present embodiment, the number of the hooking units is different from the number of the hooking units 20 of the conveying system 100 provided in the first embodiment.
  • the transport system includes a tube body 80 and a plurality of hooking units.
  • the tube body 80 includes an inner sheath tube 81, an outer sheath tube 82, an inner sheath core tube 83, and a Tip head 84.
  • Three hooking units are provided on the outer surface of the inner sheath core tube 83. And three hooking units are evenly spaced along the axial direction of the inner sheath core tube 83.
  • the first hooking unit 91 is disposed above the outer surface of the inner sheath core tube 83 near the proximal end.
  • the first hooking unit 91 has three hooking members 911.
  • Each of the hooks 911 has a deformation portion 9111.
  • the deformed portion 9111 of the hooking member 911 extends toward the proximal end, and is inside.
  • the angle between the proximal end to the distal end of the sheath core tube 83 ranges from 0 degrees to 180 degrees.
  • the angle between the extending direction of the deformation portion 9111 and the direction from the proximal end to the distal end of the inner sheath core tube 83 ranges from 30 degrees to 90 degrees. Specifically, in the present embodiment, the angle between the extending direction of the deformed portion 9111 and the direction from the proximal end to the distal end of the inner sheath core tube 83 is 60 degrees.
  • the first hooking unit 91 can ensure that the lumen bracket 200 is fixed on the inner sheath core tube 83 during the process of withdrawing the tube body 80 or adjusting the distal end of the tube body 80, and no relative relationship occurs with the outer sheath tube 82. Move to avoid early release of lumen stent 200.
  • the third hooking unit 93 is disposed above the outer surface of the inner sheath core tube 83 near the distal end.
  • the third hooking unit 93 has three hooking members 931.
  • Each of the hooks 931 has a deformation portion 9311.
  • the deformation portion 9311 of the hooking member 931 extends distally, and the inner sheath core tube 83
  • the angle between the proximal to distal directions ranges from 0 to 180 degrees.
  • the angle between the deformation portion 9311 and the direction from the proximal end to the distal end of the inner sheath core tube 83 ranges from 90 degrees to 150 degrees. Specifically, in the present embodiment, the angle between the extending direction of the deformation portion 9311 and the direction from the proximal end to the distal end of the inner sheath core tube 83 is 120 degrees.
  • the lumen stent 200 is generated due to friction between the lumen stent 200 and the inner wall of the outer sheath tube 82. The trend of moving to the near end.
  • the third hooking unit 93 can prevent the lumen bracket 200 from moving to the proximal end, thereby reducing the possibility of the lumen stent 200 being stacked and reducing the release resistance of the lumen stent 200.
  • the second hooking unit 92 is disposed between the first hooking unit 91 and the third hooking unit 93, and the distance between the second hooking unit 92 and the first hooking unit 91 and the second hooking unit 92 to the third The distances of the hooking units 93 are equal.
  • the second hooking unit 92 has three hooking members 921. Each of the hooks 921 has a deformation portion 9211.
  • the deformed portion 9211 of the hooking member 921 extends distally, and the inner sheath core tube
  • the angle between the proximal to distal directions of 83 ranges from 0 degrees to 180 degrees. Specifically, in the present embodiment, the angle between the deformed portion 9211 and the direction from the proximal end to the distal end of the inner sheath core tube 83 is 90 degrees.
  • the second hooking unit 92 can cooperate with the first hooking unit 91 to ensure that during the withdrawal of the tubular body 80 or the distal end of the tubular body 80, the lumen stent 200 is It is fixed on the inner sheath core tube 83, and no relative movement occurs between the outer sheath tube 82 and the lumen bracket 200 is prevented from being released in advance.
  • the second hooking unit 92 can cooperate with the third hooking unit 93 to further prevent the lumen bracket 200 from accumulating and reduce the release resistance of the lumen bracket 200.
  • the outer sheath tube 82 can be driven relative to the inner sheath.
  • the core tube 83 is axially moved distally, and the tube stent 200, the second hooking unit 92, and the third hooking unit 93, which have been partially released, are re-accommodated between the outer sheath tube 82 and the inner sheath core tube 83. In the cavity.
  • a greater number of hooking units 90 may be provided on the outer surface of the inner sheath core tube 83 (see Figure 16).
  • the plurality of hooking units 90 are evenly or unevenly spaced along the axial direction of the inner sheath core tube 83.
  • the hooks of the plurality of hooking units 90 are not in contact with each other.
  • the number of hooking units 90 has a positive correlation with the axial length of the lumen support 200.
  • a delivery system having a plurality of hooking units 90 is particularly suitable for the delivery and release of bare stents of longer axial length.
  • the plurality of hooks of the plurality of hooking units are respectively hooked to the waveforms of different portions of the bare bracket.
  • the fixed relationship between the bare stent and the inner sheath core tube is more reliable, and the relative movement between the bare stent and the inner sheath core tube during the loading process can be effectively prevented.
  • the slider moves to pull the proximal sheath axially relative to the proximal end of the inner sheath core tube, so that the bare stent and the hook and the outer sheath tube are oppositely motion.
  • the inner wall of the outer sheath tube disappears from the tendency of the free end of the deformed portion of the hooking member to expand radially outward along the inner sheath core tube, and is made of an elastic material.
  • the hooking member is released from the cavity between the outer sheath tube and the inner sheath core tube, and the deformed portion of the hooking member is restored to the unfolded state due to its elasticity, and is automatically separated from the skeleton at the peak of the hooked bare bracket.
  • the plurality of hooking units are released one by one from the outer sheath tube and automatically separated from the skeleton of the hooked bare stent peak until the entire bare stent is completely released from the outer sheath tube.
  • the number of the hooking units and the tube of the hooking unit in the inner sheath core tube can be adjusted.
  • the locations on the outer surface of the body are such that the number and location of the hooking units accommodate the skeletal structure of the lumen stent.
  • the delivery system provided by this embodiment has at least the following beneficial effects:
  • the lumen stent With the withdrawal of the outer sheath tube, the lumen stent can be released piece by piece, and the released lumen stent relies on its own elastic expansion and attaches to the blood vessel wall, and does not affect the release and expansion of the remaining portion of the lumen stent.
  • the distal position of the tube body can be adjusted, and the advance release of the lumen stent is not caused during the adjustment process.
  • the lumen stent can be recovered into the outer sheath tube, withdrawn from the patient's body, and the appropriate size of the lumen stent can be replaced.
  • the delivery system provided by the invention is suitable for transporting a blood vessel stent, for example, for simultaneously opening aortic arch stenosis and left subclavian artery stenosis, placing a chimney bracket or a top hat bracket in the left subclavian artery, or conveying a tracheal stent and an esophageal stent to realize a product release position. Adjustment and recycling.

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Abstract

L'invention concerne un système de transport (100) d'un implant (200), le système de transport comprenant un tube de gaine interne (11), un tube central de gaine interne (13) pénétrant dans le tube de gaine interne (11) et une extrémité distale de ce dernier s'étendant à partir du tube de gaine interne (11), et un tube de gaine externe (12) gainé mobile à l'extérieur du tube de gaine interne (11) et présentant une cavité à partir du tube central de gaine interne (13). Le système de transport (100) comprend en outre au moins une unité de crochet (20) fixée sur une surface externe du tube central de gaine interne (13), l'unité de crochet (20) comprenant au moins deux éléments de crochet souples (22), chacun des éléments de crochet (22) comprenant une partie de fixation (221) reliée à la surface externe du tube central de gaine interne (13) et une partie de déformation (222) reliée à la partie de fixation (221), et une extrémité libre de la partie de déformation (222) pouvant être pliée par rapport à la partie de fixation (221), et, lorsqu'elle est logée dans une cavité entre le tube de gaine externe (12) et le tube central de gaine interne (13), l'extrémité libre étant adaptée à la partie de fixation (221) en vue de former un objet en forme de crochet. L'implant (200) est fixé au tube central de gaine interne (13) par l'intermédiaire de l'unité de crochet (20), ce qui permet de limiter le mouvement de l'implant (200). Ainsi, pendant le processus de transport de l'implant (200), aucun déplacement de l'implant (200) relativement au tube central de gaine interne (13) ne se produit. De plus, pendant le processus de libération, lorsqu'un réglage d'une position de libération de l'implant (200) est nécessaire, une libération de l'implant (200) à l'avance peut être évitée.
PCT/CN2017/114809 2016-12-08 2017-12-06 Système de transport d'implant WO2018103662A1 (fr)

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CN201611123762.6A CN108186176B (zh) 2016-12-08 2016-12-08 植入物的输送系统

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CN113440324B (zh) * 2020-03-26 2023-08-01 先健科技(深圳)有限公司 支架输送系统
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