WO2023109315A1 - Stent delivery device and stent delivery system - Google Patents

Stent delivery device and stent delivery system Download PDF

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Publication number
WO2023109315A1
WO2023109315A1 PCT/CN2022/126976 CN2022126976W WO2023109315A1 WO 2023109315 A1 WO2023109315 A1 WO 2023109315A1 CN 2022126976 W CN2022126976 W CN 2022126976W WO 2023109315 A1 WO2023109315 A1 WO 2023109315A1
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WO
WIPO (PCT)
Prior art keywords
stent
sleeve
stent delivery
delivery device
release
Prior art date
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PCT/CN2022/126976
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French (fr)
Chinese (zh)
Inventor
曹洋
张宇
王金耀
高凌岳
朱清
Original Assignee
上海拓脉医疗科技有限公司
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Application filed by 上海拓脉医疗科技有限公司 filed Critical 上海拓脉医疗科技有限公司
Publication of WO2023109315A1 publication Critical patent/WO2023109315A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve

Definitions

  • the invention relates to the technical field of medical devices, in particular to a stent delivery device and a stent delivery system.
  • Transjugular Intrahepatic Portosystemic Shunt is a minimally invasive treatment technique that implants a stent between the portal vein and the hepatic vein to establish a portosystemic shunt channel to reduce portal vein pressure. Treatment of related complications such as intractable ascites, rupture and bleeding of esophageal and gastric varices caused by portal hypertension.
  • a TIPS covered stent usually includes a bare segment and a covered segment. Among them, the length of the bare segment is about 20mm, which is used for positioning in the portal vein, so as to ensure that the blood perfusion of the portal vein to other branches is not affected; Prevent bile erosion.
  • the introduction path of the TIPS covered stent system is: first enter the inferior vena cava through the jugular vein, then enter the hepatic vein through the inferior vena cava, and then lead out from the puncture port of the hepatic vein and enter the portal vein after passing through the liver parenchyma. After positioning, withdraw the stent system as a whole until the golden developing ring at the junction of the bare segment and the covered segment coincides with the puncture port of the portal vein, and the operating system releases the covered segment of the stent in the liver. At this time, the bare stent segment is still bound in the liver. On the post-release device, after the covered segment of the stent is completely released in the liver, the post-release device is operated to release the bare stent segment into the portal vein.
  • the stent delivery device in the prior art releases the stent, there will inevitably be a certain "jump forward" phenomenon, and the stent will more or less deviate from the expected position after the stent is released, while the TIPS covered stent generally has a bare During the release, the bare segment has been released in advance and "floats" in the portal vein, and is impacted by the blood flow of the portal vein. At the same time, there is a significant difference in the radial support force between the covered segment and the bare segment, and the covered segment is released when it is released. Due to the uneven extrusion force of the liver parenchyma, the stent is prone to displacement. If the covered segment enters the portal vein, it will cause the risk of blocking the portal vein branch.
  • a stent delivery device is used to deliver a stent, comprising: an inner tube, an outer tube, a limiting sleeve and a releasing sleeve.
  • the limit sleeve and the release sleeve are sleeved on the outside of the inner tube, the outer tube is sleeved on the outside of the limit sleeve and the release sleeve, and the limit sleeve Located on the distal side of the release sleeve.
  • the distal end of the release sleeve is provided with a binding wire, and the binding wire is used to bind the bare section of the stent to the outside of the limit sleeve, and the release sleeve is arranged to move towards the position under the action of external force.
  • the proximal end of the outer tube is moved until the binding wire releases the binding of the bare segment.
  • the binding wire when the stent is clinically implanted, can bind the bare section of the stent to the outside of the limiting sleeve, thereby binding the bare section, and when the covered section of the stent is first released, the bare section itself will Unable to self-expand, the stent cannot "jump forward", which can effectively avoid the displacement of the stent due to "jump forward", thereby reducing the risk of blocking the portal vein branch and ensuring the precise release of the stent.
  • the limiting sleeve is provided with a wire passing hole along the direction from its proximal end to the distal end, and the outer side wall of the limiting sleeve is provided with a limiting groove communicating with the wire passing hole .
  • the binding wire can pass through the wire passing hole and is configured to be able to be pulled out from the wire passing hole under the action of an external force.
  • the thread passing holes and the limiting grooves are evenly distributed along the circumferential direction of the limiting sleeve, and the binding wires are evenly distributed along the circumferential direction of the releasing sleeve and extend in the axial direction.
  • the wire hole is a blind hole.
  • the limiting groove communicates with the lumen of the limiting sleeve.
  • one or more limiting grooves are provided in the axial direction.
  • the outer wall of the limiting sleeve is respectively provided with a plurality of limiting grooves in the axial and circumferential directions, and the plurality of limiting grooves are evenly spaced in the axial and circumferential directions. .
  • the proximal end of the release sleeve is provided with a release wire, and the release wire is configured to be able to pull the release sleeve to move under the action of an external force.
  • a reinforcing part is formed at the proximal end of the limiting sleeve, and an outer wall of at least one of the reinforcing part and the releasing sleeve is a wear-increasing structure.
  • the stent delivery device further includes a tapered guide detachably connected to the port at the distal end of the outer tube, and the distal end of the inner tube is connected to the tapered guide.
  • the stent delivery device further includes: a handle, an ejection head, and an elastic member.
  • the handle is connected to the proximal end of the outer tube, the ejector head and the elastic member are arranged in the outer tube, the distal end of the ejector head is used to abut against the proximal end of the bracket, the Both ends of the elastic member are respectively connected with the handle and the ejector head.
  • the proximal end of the inner tube passes through the ejector head and is connected with the handle.
  • the distal end of the ejector head is provided with a bracket installation boss, and/or the proximal end of the ejector head is provided with an elastic member installation boss.
  • the installation boss of the elastic member has a tube hole, and the proximal end of the inner tube passes through the tube hole to connect with the handle.
  • the bare segment is a mesh structure, including a plurality of stent segments distributed sequentially along the axial direction, and the vertices of two adjacent stent segments are interlocked.
  • the number of the wire passing holes, the number of the binding wires, and the number of the limit slots in the circumferential direction are the same as the number of vertices of each stent segment.
  • a stent delivery system comprising a stent and a stent delivery device as described above.
  • the binding wire when the stent is clinically implanted, can bind the bare section of the stent to the outside of the limiting sleeve, thereby binding the bare section.
  • the covered section of the stent is released first, the bare section itself Unable to self-expand, the stent cannot "jump forward", which can effectively avoid the displacement of the stent due to "jump forward", thereby reducing the risk of blocking the portal vein branch and ensuring the precise release of the stent.
  • Fig. 1 is a partial structural schematic diagram of a stent delivery system provided by an embodiment of the present invention
  • Fig. 2 is a schematic structural diagram of a limit sleeve provided by an embodiment of the present invention
  • Fig. 3 is a sectional view of the limit sleeve shown in Fig. 2;
  • Fig. 4 is a schematic structural diagram of a limit sleeve provided by another embodiment of the present invention.
  • Fig. 5 is a sectional view of the limit sleeve shown in Fig. 4;
  • Fig. 6 is a schematic structural diagram of a release sleeve provided by an embodiment of the present invention.
  • FIG. 7 is a schematic diagram of a partial structure of a bare segment provided by an embodiment of the present invention.
  • FIGS. 8 to 11 are schematic diagrams of the implantation process of the stent delivery system provided by an embodiment of the present invention.
  • Fig. 12 is a schematic structural diagram of an ejector head provided by an embodiment of the present invention.
  • frame conveying device 100, inner tube; 200, outer tube; 300, limit sleeve; 310, wire hole; 320, limit groove; 330, lumen; 340, reinforcement; 400, release sleeve ; 410, binding wire; 420, release wire; 500, tapered guide head; 600, ejection head; 610, bracket installation boss; 620, elastic member installation boss; 630, through hole; 700, elastic member; 800, Stent; 810, bare segment; 811, stent segment; 812, apex; 820, covered segment; 830, developing ring; A1, liver; A2, inferior vena cava; A3, right hepatic vein; A4, puncture channel; A5, portal vein.
  • first and second are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features.
  • the features defined as “first” and “second” may explicitly or implicitly include at least one of these features.
  • “plurality” means at least two, such as two, three, etc., unless otherwise specifically defined.
  • the first feature may be in direct contact with the first feature or the first and second feature may be in direct contact with the second feature through an intermediary. touch.
  • “above”, “above” and “above” the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature.
  • “Below”, “beneath” and “beneath” the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply mean that the first feature is less horizontally than the second feature.
  • an embodiment of the present invention provides a stent delivery device 10, the stent delivery device 10 includes: an inner tube 100, an outer tube 200, a limiting sleeve 300 and a releasing sleeve 400; the limiting sleeve 300 .
  • the release sleeve 400 is sleeved on the outside of the inner tube 100 .
  • the outer tube 200 is sleeved on the outside of the limiting sleeve 300 and the release sleeve 400 .
  • the limiting sleeve 300 is located at the distal side of the release sleeve 400 .
  • the distal end of the release sleeve 400 is provided with a binding wire 410
  • the binding wire 410 is used to bind the bare section 810 of the stent 800 to the outside of the limiting sleeve 300
  • the release sleeve 400 can be used under the action of external force Move downward toward the proximal end of the outer tube 200 until the tethering wire 410 unconstrains the bare segment 810 .
  • each component of the stent delivery device refers to the end of the components first entering the patient's liver A1
  • the proximal end of each component of the stent delivery device refers to the end close to the operator.
  • the stent delivery device is applied in the medical field, and is used to deliver the medical stent to the diseased part of the patient.
  • the medical stent can be a medical stent such as an intestinal stent, a vascular stent, and the vascular stent can be a stent 800 including only a bare section 810 , or a TIP covered stent 800 including a bare section 810 and a covered section 820 . Referring to Fig. 1, the part circled by the dotted line in Fig.
  • the TIP covered stent 800 is the TIP covered stent 800
  • the length of the bare section 810 is about 20mm, and it is sleeved on the outside of the position-limiting sleeve 300 for positioning in the portal vein to ensure Branch blood perfusion is not affected.
  • the covered section 820 has a length of about 40 mm to 80 mm and is sheathed outside the release sleeve 400 for positioning in the liver parenchyma to effectively prevent bile erosion.
  • Ring 830 such as a gold developer ring.
  • the bare segment 810 is a mesh structure, including a plurality of stent segments 811 distributed sequentially along the axial direction, and the vertices 812 of two adjacent stent segments 811 are interlocked.
  • the stent 800 including the covering segment 820 includes a plurality of stent segments distributed sequentially along the axial direction, and two adjacent stent segments are distributed at intervals and connected by connecting rods.
  • the material, structure and working process of the stent delivery device 10 will be described below taking the TIP stent graft 800 as an example.
  • the inner tube 100, outer tube 200, limit sleeve 300 and release sleeve 400 of the stent delivery device are plastic materials with biodegradability, safety and certain hardness, such as PE (Polyethene, polyethylene ) material, which can meet the requirement that the stent delivery device itself can be bent correspondingly with the blood vessel during the implantation process.
  • PE Polyethene, polyethylene
  • the inner tube 100, the outer tube 200, the limiting sleeve 300 and the releasing sleeve 400 can all be circular tubes.
  • the tethering wire 410 on the release sleeve 400 is made of biodescriptive, safe and hard metal, such as nickel-titanium.
  • the TIP covered stent 800 is first assembled into the stent accommodating cavity formed between the outer tube 200 and the inner tube 100 of the stent delivery device. Specifically, the TIP stent-graft 800 is placed outside the inner tube 100 and the bare section 810 of the TIP stent-graft 800 is aligned with the limit sleeve 300; then the binding wire 410 of the sleeve 400 is released and the bare section 810 bound to the outside of the limiting sleeve 300 ; then the outer tube 200 is placed outside the inner tube 100 , and the limiting sleeve 300 , the releasing sleeve 400 and the TIP stent graft 800 are all assembled into the outer tube 200 .
  • the stent delivery device 10 enters the inferior vena cava A2 through the patient's jugular vein approach, adjusts its direction, enters the right hepatic vein A3, and then introduces the portal vein A5 through the artificial channel established by puncture in advance.
  • the stent delivery device 10 after the stent delivery device 10 enters the designated position of the portal vein A5, the stent delivery device 10 is withdrawn as a whole, and the withdrawal is stopped when the developing ring 830 of the TIP covered stent 800 completely overlaps with the puncture port of the portal vein A5. Then withdraw the outer tube 200, and stop after the TIP covered stent 800 is completely released from the outer tube 200. At this time, the covered segment 820 of the TIP covered stent 800 has been released in the puncture channel A4 of the liver A1, but The bare section 810 of the TIP stent-graft 800 is still bound by the binding wire 410 to the outside of the limiting sleeve 300 .
  • the release sleeve 400 is then pulled towards the proximal end of the outer tube 200, the binding wire 410 is withdrawn to the proximal end as a whole following the release sleeve 400, the bare section 810 is freed from the binding of the binding wire 410, and the bare section 810 is released in the portal vein A5, and finally, the stent delivery device 10 is withdrawn from the human body.
  • the binding wire 410 can bind the bare section 810 of the stent 800 to the outside of the limiting sleeve 300 , thereby binding the bare section 810 .
  • the coated section 820 of the stent 800 is released first, the bare section 810 cannot self-expand and expand, and the stent 800 cannot "jump forward", which can effectively avoid the displacement of the stent 800 due to "jump forward”. Reduce the risk of blocking the A5 branch of the portal vein, and ensure accurate release of the stent 800 .
  • the limit sleeve 300 is provided with a wire passing hole 310 along the direction from its proximal end to the distal end, and the outer wall of the limit sleeve 300 is provided with a thread passing hole 310 .
  • the hole 310 communicates with the limiting groove 320 , and the binding wire 410 can pass through the wire passing hole 310 and can be pulled out from the wire passing hole 310 under the action of an external force.
  • the binding wire 410 can pass through the wire hole 310 and the mesh of the bare section 810 , so as to bind the bare section 810 in the limiting groove 320 , and further play the role of binding the bare section 810 .
  • the limiting groove 320 can accommodate a part of the bare section 810 in the radial direction without increasing the diameter of the outer tube 100 .
  • the outer wall of the limiting sleeve 300 refers to the side wall of the limiting sleeve 300 parallel to its own axis, not the proximal and distal end surfaces of the limiting sleeve 300 .
  • each vertex 812 of each stent segment 811 of the bare segment 810 can be effectively constrained.
  • the number of thread passing holes 310, binding wires 410, and limit grooves 320 in the circumferential direction may be the same as the number of vertices 812 of each bracket segment 811.
  • each bracket segment 811 has 6 vertices 812, Then, the number of thread passing holes 310 , binding wires 410 , and the limiting slots 320 in one circle in the circumferential direction can all be six. As another example, each bracket segment 811 has 12 vertices 812 , so the number of thread passing holes 310 , binding wires 410 , and limiting slots 320 in the circumferential direction can all be 12.
  • the wire passing hole 310 is a blind hole, that is, the wire passing hole 310 penetrates the proximal end of the limiting sleeve 300 but does not penetrate the distal end of the limiting sleeve 300 .
  • the binding wire 410 can be confined in the proximal end of the thread passing hole 310 , and the bare section 810 can be effectively bound.
  • the limiting groove 320 communicates with the lumen 330 of the limiting sleeve 300 .
  • Such arrangement can not only ensure that the limiting groove 320 has enough space to limit the bare section 810, but also can observe whether the limiting sleeve 300 and the inner tube 100 are assembled in place.
  • the limiting sleeve 300 and the inner tube 100 can be integrally formed.
  • limiting grooves 320 there are multiple limiting grooves 320 , and the plurality of limiting grooves 320 are evenly spaced in the axial and circumferential directions.
  • a plurality of limiting grooves 320 are provided at intervals along the axial direction of the limiting sleeve 300 , and the structure of multiple discontinuous grooves can ensure the strength of the limiting sleeve 300 .
  • a limit groove 320 can also be continuously opened along the axial direction of the limit sleeve 300.
  • the single continuous groove structure is convenient to open, and the structure of the limit groove 320 can be adjusted according to the actual situation during application. Make specific settings.
  • the distance between two adjacent limiting grooves 320 needs to be determined according to the distance between two adjacent bracket segments 811 of the bare segment 810. Otherwise, the bracket segment 811 of the bare segment 810 cannot be smoothly bound on the outer surface of the limiting sleeve 300 .
  • the limiting grooves 320 may be distributed along the axial direction of the limiting sleeve 300 , so that the binding wire 410 can limit the bare section 810 in the limiting grooves 320 with less force.
  • a release wire 420 is provided at the proximal end of the release sleeve 400 , and the release wire 420 can pull the release sleeve 400 to move under the action of an external force.
  • the release wire 420 is pulled, and the tie wire 410 is retracted proximally along with the release sleeve 400 as a whole, and the bare section 810 is released from the bondage of the tie wire 410.
  • the release of the bare segment 810 is facilitated by the arrangement of the release wire 420 .
  • the wire diameter of the releasing wire 420 may be smaller than that of the binding wire 410 .
  • the release wire 420 is made of a metal material with biodegradability, safety and certain hardness, such as nickel-titanium material, stainless steel.
  • the number of release wires 420 can be specifically set according to actual conditions, for example, 1, 2, 3, etc. are set.
  • a reinforced portion 340 is formed at the proximal end of the limiting sleeve 300 , and the outer wall of the reinforced portion 340 is a wear-increasing structure; and/or, the release sleeve 400
  • the outer wall is a wear-increasing structure.
  • the reinforcement part 340 can increase the strength of the limiting sleeve 300; in addition, the increased wear structure on the reinforcement part 340 and the release sleeve 400 can increase the strength of the reinforcement part 340 when the coating section 820 of the TIP stent coating 800 is released.
  • the friction between the outer surface of the release sleeve 400 and the inner surface of the covered section 820 can provide a part of resistance to the release of the TIP covered stent 800, which can effectively weaken the "forward jump" phenomenon when the TIP covered stent 800 is released, ensuring The release position of the TIP stent graft 800 is precise. It can be understood that the wire hole 310 penetrates to the proximal end surface of the reinforcement part 340 .
  • the abrasive structure is a frosted structure.
  • a plurality of protrusions may also be provided on the outer walls of the reinforcement part 340 and the release sleeve 400 to form a wear-increasing structure.
  • the stent delivery device 10 further includes a tapered guide 500 detachably connected to the distal port of the outer tube 200 , and the distal end of the inner tube 100 is connected to the tapered guide 500 .
  • the tapered guide head 500 can play a guiding role during the implantation process of the stent delivery device.
  • the tapered guide head 500 is fitted to the distal port of the outer tube 200 through an interference fit, which facilitates the retraction of the outer tube 200 .
  • the stent delivery device 10 also includes: a handle (not shown in the drawings), an ejection head 600 and an elastic member 700; the handle is connected to the proximal end of the outer tube 200, and the ejection head 600 and the elastic member 700 are arranged on Inside the outer tube 200, the distal end of the ejection head 600 is used to abut against the proximal end of the bracket 800, and the two ends of the elastic member 700 are respectively connected to the handle and the ejection head 600; the proximal end of the inner tube 100 passes through the ejection head 600 and the handle connect.
  • a handle not shown in the drawings
  • an ejection head 600 and an elastic member 700 are arranged on Inside the outer tube 200, the distal end of the ejection head 600 is used to abut against the proximal end of the bracket 800, and the two ends of the elastic member 700 are respectively connected to the handle and the ejection head 600; the proximal end of the inner tube 100 passes through the ejection head 600 and the handle
  • the proximal end of the covering segment 820 is hindered by the distal end of the ejection head 600 and is "pushed" out of the outer tube 200.
  • the covering segment 820 has been released in the puncture channel A4 of the liver A1.
  • the ejection head 600 is provided with a through hole 630 along the direction from the proximal end to the distal end thereof, and the through hole 630 is used for releasing the release wire 420 .
  • the through holes 630 may be distributed along the axial direction of the ejection head 600 .
  • the elastic member 700 may be a spring, and the elastic member is mainly to facilitate the front end of the stent delivery device to adapt to a curved blood vessel.
  • the proximal end of the ejector head 600 is provided with an elastic member installation boss 620 , and the distal end of the elastic member 700 can be sleeved on the elastic member installation boss 620 .
  • the elastic member installation boss 620 has a tube hole, and the proximal end of the inner tube 100 passes through the tube hole to be connected with the handle. The proximal end of the inner tube 100 passes through the elastic member installation boss 620, and then passes through the elastic member 700 to be connected with the handle.
  • the distal end of the ejection head 600 is provided with a bracket installation boss 610 .
  • the proximal end of the covered segment 820 of the TIP covered stent 800 is sleeved on the outside of the bracket installation boss 610 .
  • the distal end of the release sleeve 400 is provided with a binding wire 410, and the outer diameter of the release sleeve 400 is larger than the outer diameter of the limiting sleeve 300, so that the binding wire 410 can bind the bare segment of the stent in a limited position. outside of the casing.
  • a stent delivery system which includes a stent 800 and any one of the above-mentioned stent delivery devices 10 .
  • the binding wire 410 of the stent delivery device 10 is used to bind the bare section 810 of the stent 800 to the outside of the limit sleeve 300 of the stent delivery device 10, and the release sleeve 400 can move towards the proximal end of the outer tube 200 under the action of external force. Move until the tethering wire 410 unbinds the bare segment 810 .
  • the stent may be a medical stent such as an intestinal stent or a blood vessel stent, wherein the blood vessel stent may be a stent including only a bare segment, or a TIP covered stent including a bare segment and a covered segment.
  • the part circled by the dotted line in Fig. 1 is the TIP covered stent 800, the length of the bare section 810 is about 20mm, and it is sleeved on the outside of the position-limiting sleeve 300 for positioning in the portal vein to ensure Branch blood perfusion is not affected.
  • the covered section 820 has a length of about 40 mm to 80 mm and is sheathed outside the release sleeve 400 for positioning in the liver parenchyma to effectively prevent bile erosion.
  • Ring 830 such as a gold developer ring.
  • the bare segment 810 is a mesh structure, including a plurality of stent segments 811 distributed sequentially along the axial direction, and the vertices 812 of two adjacent stent segments 811 are interlocked; the stent 800 of the covered segment 820 includes A plurality of stent segments are distributed sequentially along the axial direction, and two adjacent stent segments are distributed at intervals and connected by connecting rods.
  • the tethering wire 410 can bind the bare section 810 of the membrane stent 800 to the outside of the spacer sleeve 300, thereby constraining the bare section 810, and releasing the stent 800 first.
  • the coated section 820 is used, the bare section 810 cannot self-expand, and the stent 800 cannot "jump forward", which can effectively avoid the displacement of the stent 800 due to "jump forward", thereby reducing the chance of blocking the A5 branch of the portal vein. risk, ensure accurate release of the stent 800.

Abstract

A stent delivery device (10) and a stent delivery system. The stent delivery device (10) comprises an inner tube (100), an outer tube (200), a restraining sheath (300), and a release sheath (400). The restraining sheath (300) and the release sheath (400) sleeve the inner tube (100), the outer tube (200) sleeves the restraining sheath (300) and the release sheath (400), and the restraining sheath (300) is located on the distal end side of the release sheath (400). The distal end of the release sheath (400) is provided with restraining wires (410), the restraining wires (410) being used for restraining a bare section (810) of a stent (800) outside the restraining sheath (300). The release sheath (400) is configured to move towards the proximal end of the outer tube (200) under an external force until the restraining wires (410) no longer restrain the bare section (810).

Description

支架输送装置及支架输送系统Stent delivery device and stent delivery system
相关申请的交叉引用Cross References to Related Applications
本申请要求于2021年12月14日提交中国专利局,申请号为202111528102.7,名称为“支架输送装置及支架输送系统”的中国专利申请的优先权,在此将其全文引入作为参考。This application claims the priority of the Chinese patent application with application number 202111528102.7 and titled "Stent delivery device and stent delivery system" submitted to the China Patent Office on December 14, 2021, which is hereby incorporated by reference in its entirety.
技术领域technical field
本发明涉及医疗器械技术领域,特别是涉及一种支架输送装置及支架输送系统。The invention relates to the technical field of medical devices, in particular to a stent delivery device and a stent delivery system.
背景技术Background technique
经颈静脉肝内门体分流术(Transjugular Intrahepatic Portosystemic Shunt,TIPS),是一种在门静脉和肝静脉之间植入支架建立门-体分流通道,达到降低门静脉压力的微创治疗技术,用于治疗由于门静脉高压引起的顽固性腹水、食管胃底静脉曲张破裂出血等相关并发症。Transjugular Intrahepatic Portosystemic Shunt (TIPS) is a minimally invasive treatment technique that implants a stent between the portal vein and the hepatic vein to establish a portosystemic shunt channel to reduce portal vein pressure. Treatment of related complications such as intractable ascites, rupture and bleeding of esophageal and gastric varices caused by portal hypertension.
在经颈静脉肝内门体分流术时,需预先进行经颈静脉肝内穿刺以建立人工通道,随后沿该通道将TIPS覆膜支架输送并释放在目标位置,从而建立门-体分流通道,以达到降低门静脉血流压力的效果。TIPS覆膜支架通常包括裸段和覆膜段。其中,裸段的长度约为20mm,用于定位在门静脉中,保证门静脉向其他分支的血流灌注不受影响;覆膜段的长度约为40mm~80mm,用于定位在肝脏实质中,有效防止胆汁侵蚀。TIPS覆膜支架系统的导入路径为:先经颈静脉入路进入下腔静脉,然后经下腔静脉进入肝静脉,再从肝静脉穿刺口导出并通过肝脏实质后进入门静脉,待支架系统到达指定位置后,整体回撤支架系统,直至裸段与覆膜段的交界处的黄金显影环与门静脉穿刺口重合,操作系统释放支架覆膜段于肝脏中,此时,裸支架段依然被束缚在后释放装置上,待支架覆膜段完全释放于肝脏中后,操作后释放装置,将裸支架段释放于门静脉。In transjugular intrahepatic portosystemic shunt, it is necessary to perform transjugular intrahepatic puncture in advance to establish an artificial channel, and then deliver and release the TIPS-covered stent along the channel to establish a portosystemic shunt channel. In order to achieve the effect of reducing portal venous blood pressure. A TIPS covered stent usually includes a bare segment and a covered segment. Among them, the length of the bare segment is about 20mm, which is used for positioning in the portal vein, so as to ensure that the blood perfusion of the portal vein to other branches is not affected; Prevent bile erosion. The introduction path of the TIPS covered stent system is: first enter the inferior vena cava through the jugular vein, then enter the hepatic vein through the inferior vena cava, and then lead out from the puncture port of the hepatic vein and enter the portal vein after passing through the liver parenchyma. After positioning, withdraw the stent system as a whole until the golden developing ring at the junction of the bare segment and the covered segment coincides with the puncture port of the portal vein, and the operating system releases the covered segment of the stent in the liver. At this time, the bare stent segment is still bound in the liver. On the post-release device, after the covered segment of the stent is completely released in the liver, the post-release device is operated to release the bare stent segment into the portal vein.
现有技术中的支架输送装置在释放支架时,不可避免会出现一定的“前跳”现象,支架释放完毕后或多或少地会偏离预期位置,而TIPS覆膜支架一般具有20mm长度的裸段,在释放时,裸段已经提前释放出来并“飘”在门静脉中,受到门静脉血流的冲击,同时覆膜段与裸段的径向支撑力有着显著差别,且覆膜段在释放时受到肝脏实质的不均挤压力,从而导致支架极易出现移位,若覆膜段进入门静脉中,将会引起堵塞门静脉分支的风险。When the stent delivery device in the prior art releases the stent, there will inevitably be a certain "jump forward" phenomenon, and the stent will more or less deviate from the expected position after the stent is released, while the TIPS covered stent generally has a bare During the release, the bare segment has been released in advance and "floats" in the portal vein, and is impacted by the blood flow of the portal vein. At the same time, there is a significant difference in the radial support force between the covered segment and the bare segment, and the covered segment is released when it is released. Due to the uneven extrusion force of the liver parenchyma, the stent is prone to displacement. If the covered segment enters the portal vein, it will cause the risk of blocking the portal vein branch.
发明内容Contents of the invention
基于此,有必要针对现有的支架输送装置使得TIP覆膜支架易出现“前跳”现象的技术问题,提供一种支架输送装置及支架输送系统。Based on this, it is necessary to provide a stent delivery device and a stent delivery system for the technical problem that the existing stent delivery device makes the TIP covered stent prone to "jump forward".
一种支架输送装置,用于输送支架,包括:内管、外管、限位套管及释放套管。A stent delivery device is used to deliver a stent, comprising: an inner tube, an outer tube, a limiting sleeve and a releasing sleeve.
所述限位套管、所述释放套管套设于所述内管的外部,所述外管套设于所述限位套管、所述释放套管的外部,所述限位套管位于所述释放套管的远端侧。The limit sleeve and the release sleeve are sleeved on the outside of the inner tube, the outer tube is sleeved on the outside of the limit sleeve and the release sleeve, and the limit sleeve Located on the distal side of the release sleeve.
所述释放套管的远端设置有束缚丝,所述束缚丝用于将支架的裸段束缚于所述限位套管的外部,所述释放套管设置为在外力的作用下朝着所述外管的近端运动直至所述束缚丝解除对所述裸段的束缚。The distal end of the release sleeve is provided with a binding wire, and the binding wire is used to bind the bare section of the stent to the outside of the limit sleeve, and the release sleeve is arranged to move towards the position under the action of external force. The proximal end of the outer tube is moved until the binding wire releases the binding of the bare segment.
上述支架输送装置,在临床植入支架时,束缚丝可将支架的裸段束缚于限位套管的外部,从而对裸段进行束缚,在先行释放支架的覆膜段时,裸段自身便无法自膨展开,支架也就无法“前跳”,可有效避免支架由于“前跳”所导致的移位,进而可降低堵塞门静脉分支的风险,确保支架精准释放。The above-mentioned stent delivery device, when the stent is clinically implanted, the binding wire can bind the bare section of the stent to the outside of the limiting sleeve, thereby binding the bare section, and when the covered section of the stent is first released, the bare section itself will Unable to self-expand, the stent cannot "jump forward", which can effectively avoid the displacement of the stent due to "jump forward", thereby reducing the risk of blocking the portal vein branch and ensuring the precise release of the stent.
在其中一个实施例中,所述限位套管沿自身近端至远端的方向设置有过丝孔,所述限位套管的外侧壁开设有与所述过丝孔相通的限位槽。In one of the embodiments, the limiting sleeve is provided with a wire passing hole along the direction from its proximal end to the distal end, and the outer side wall of the limiting sleeve is provided with a limiting groove communicating with the wire passing hole .
所述束缚丝可穿设于所述过丝孔中且设置为在外力的作用下能够从所述过丝孔拉出。The binding wire can pass through the wire passing hole and is configured to be able to be pulled out from the wire passing hole under the action of an external force.
在其中一个实施例中,所述过丝孔、所述限位槽及所述束缚丝的数量为多个,且一一对应。In one of the embodiments, there are multiple wire passing holes, the limiting grooves, and the binding wires in one-to-one correspondence.
所述过丝孔、所述限位槽均沿所述限位套管的周向均匀分布,所述束缚丝沿所述释放套管的周向均匀分布且沿轴向方向延伸。The thread passing holes and the limiting grooves are evenly distributed along the circumferential direction of the limiting sleeve, and the binding wires are evenly distributed along the circumferential direction of the releasing sleeve and extend in the axial direction.
在其中一个实施例中,所述过丝孔为盲孔。In one embodiment, the wire hole is a blind hole.
在其中一个实施例中,所述限位槽与所述限位套管的管腔相通。In one of the embodiments, the limiting groove communicates with the lumen of the limiting sleeve.
在其中一个实施例中,所述限位槽在轴向上设置1个或多个。In one of the embodiments, one or more limiting grooves are provided in the axial direction.
在其中的一个实施例中,所述限位套管的外侧壁沿轴向和周向分别开设有多个所述限位槽,多个所述限位槽在轴向和周向上均匀间隔分布。In one of the embodiments, the outer wall of the limiting sleeve is respectively provided with a plurality of limiting grooves in the axial and circumferential directions, and the plurality of limiting grooves are evenly spaced in the axial and circumferential directions. .
在其中的一个实施例中,所述释放套管的近端设置有释放丝,所述释放丝设置为能够在外力的作用下拉动所述释放套管运动。In one of the embodiments, the proximal end of the release sleeve is provided with a release wire, and the release wire is configured to be able to pull the release sleeve to move under the action of an external force.
在其中一个实施例中,所述限位套管的近端形成有加强部,所述加强部和所述释放套管至少一个的外壁为增磨结构。In one of the embodiments, a reinforcing part is formed at the proximal end of the limiting sleeve, and an outer wall of at least one of the reinforcing part and the releasing sleeve is a wear-increasing structure.
在其中一个实施例中,所述支架输送装置还包括可拆卸地连接于所述外管远端端口处的锥形导头,所述内管的远端与所述锥形导头连接。In one of the embodiments, the stent delivery device further includes a tapered guide detachably connected to the port at the distal end of the outer tube, and the distal end of the inner tube is connected to the tapered guide.
在其中一个实施例中,所述支架输送装置还包括:手柄、顶出头以及弹性件。In one of the embodiments, the stent delivery device further includes: a handle, an ejection head, and an elastic member.
所述手柄与所述外管的近端连接,所述顶出头与所述弹性件设置于所述外管内,所述顶出头的远端用于与所述支架的近端抵接,所述弹性件的两端分别与所述手柄、所述顶出头连接。The handle is connected to the proximal end of the outer tube, the ejector head and the elastic member are arranged in the outer tube, the distal end of the ejector head is used to abut against the proximal end of the bracket, the Both ends of the elastic member are respectively connected with the handle and the ejector head.
所述内管的近端穿出所述顶出头与所述手柄连接。The proximal end of the inner tube passes through the ejector head and is connected with the handle.
在其中一个实施例中,所述顶出头的远端设置有支架安装凸台,和/或所述顶出头的近端设置有弹性件安装凸台。In one of the embodiments, the distal end of the ejector head is provided with a bracket installation boss, and/or the proximal end of the ejector head is provided with an elastic member installation boss.
在其中一个实施例中,所述弹性件安装凸台具有走管孔,所述内管的近端穿出所述走管孔与所述手柄连接。In one of the embodiments, the installation boss of the elastic member has a tube hole, and the proximal end of the inner tube passes through the tube hole to connect with the handle.
在其中一个实施例中,所述裸段为网孔结构,包括沿轴向依次分布的多个支架段,相邻两个支架段的顶点互锁。In one embodiment, the bare segment is a mesh structure, including a plurality of stent segments distributed sequentially along the axial direction, and the vertices of two adjacent stent segments are interlocked.
在其中一个实施例中,所述过丝孔的数量,所述束缚丝的数量,以及周向方向上一周的所述限位槽的数量,与每一支架段的顶点数目相同。In one of the embodiments, the number of the wire passing holes, the number of the binding wires, and the number of the limit slots in the circumferential direction are the same as the number of vertices of each stent segment.
一种支架输送系统,包括支架以及如上述任一所述的支架输送装置。A stent delivery system, comprising a stent and a stent delivery device as described above.
上述支架输送系统,在临床植入支架时,束缚丝可将支架的裸段束缚于限位套管的外部,从而对裸段进行束缚,在先行释放支架的覆膜段时,裸段自身便无法自膨展开,支架也就无法“前跳”,可有效避免支架由于“前跳”所导致的移位,进而可降低堵塞门静脉分支的风险,确保支架精准释放。The above-mentioned stent delivery system, when the stent is clinically implanted, the binding wire can bind the bare section of the stent to the outside of the limiting sleeve, thereby binding the bare section. When the covered section of the stent is released first, the bare section itself Unable to self-expand, the stent cannot "jump forward", which can effectively avoid the displacement of the stent due to "jump forward", thereby reducing the risk of blocking the portal vein branch and ensuring the precise release of the stent.
附图说明Description of drawings
图1为本发明一实施例提供的支架输送系统的局部结构示意图;Fig. 1 is a partial structural schematic diagram of a stent delivery system provided by an embodiment of the present invention;
图2为本发明一实施例提供的限位套管的结构示意图;Fig. 2 is a schematic structural diagram of a limit sleeve provided by an embodiment of the present invention;
图3为图2示出的限位套管的剖面图;Fig. 3 is a sectional view of the limit sleeve shown in Fig. 2;
图4为本发明另一实施例提供的限位套管的结构示意图;Fig. 4 is a schematic structural diagram of a limit sleeve provided by another embodiment of the present invention;
图5为图4示出的限位套管的剖面图;Fig. 5 is a sectional view of the limit sleeve shown in Fig. 4;
图6为本发明一实施例提供的释放套管的结构示意图;Fig. 6 is a schematic structural diagram of a release sleeve provided by an embodiment of the present invention;
图7为本发明一实施例提供的裸段的局部结构示意图;FIG. 7 is a schematic diagram of a partial structure of a bare segment provided by an embodiment of the present invention;
图8至图11为本发明一实施例提供的支架输送系统的植入流程示意图;8 to 11 are schematic diagrams of the implantation process of the stent delivery system provided by an embodiment of the present invention;
图12为本发明一实施例提供的顶出头的结构示意图。Fig. 12 is a schematic structural diagram of an ejector head provided by an embodiment of the present invention.
其中,说明书附图中的标号说明如下:Wherein, the label description in the accompanying drawings of the description is as follows:
10、架输送装置;100、内管;200、外管;300、限位套管;310、过丝孔;320、限位槽;330、管腔;340、加强部;400、释放套管;410、束缚丝;420、释放丝;500、锥形导头;600、顶出头;610、支架安装凸台;620、弹性件安装凸台;630、通孔;700、弹性件;800、支架;810、裸段;811、支架段;812、顶点;820、覆膜段;830、显影环;A1、肝脏;A2、下腔静脉;A3、肝右静脉;A4、穿刺通道;A5、门静脉。10, frame conveying device; 100, inner tube; 200, outer tube; 300, limit sleeve; 310, wire hole; 320, limit groove; 330, lumen; 340, reinforcement; 400, release sleeve ; 410, binding wire; 420, release wire; 500, tapered guide head; 600, ejection head; 610, bracket installation boss; 620, elastic member installation boss; 630, through hole; 700, elastic member; 800, Stent; 810, bare segment; 811, stent segment; 812, apex; 820, covered segment; 830, developing ring; A1, liver; A2, inferior vena cava; A3, right hepatic vein; A4, puncture channel; A5, portal vein.
具体实施方式Detailed ways
为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施例的限制。In order to make the above objects, features and advantages of the present invention more comprehensible, specific implementations of the present invention will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present invention, so the present invention is not limited by the specific embodiments disclosed below.
在本发明的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。In describing the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Back", "Left", "Right", "Vertical", "Horizontal", "Top", "Bottom", "Inner", "Outer", "Clockwise", "Counterclockwise", "Axial" , "radial", "circumferential" and other indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, which are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying the referred device or Elements must have certain orientations, be constructed and operate in certain orientations, and therefore should not be construed as limitations on the invention.
此外,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本发明的描述中,“多个”的含义是至少两个,例如两个,三个等,除非另有明确具体的限定。In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present invention, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.
在本发明中,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系,除非另有明确的限定。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。In the present invention, unless otherwise clearly specified and limited, terms such as "installation", "connection", "connection" and "fixation" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection , or integrated; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise specified limit. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
在本发明中,除非另有明确的规定和限定,第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触,或第一和第二特征通过中间媒介间接接触。而且,第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方,或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和 “下面”可以是第一特征在第二特征正下方或斜下方,或仅仅表示第一特征水平高度小于第二特征。In the present invention, unless otherwise clearly specified and limited, the first feature may be in direct contact with the first feature or the first and second feature may be in direct contact with the second feature through an intermediary. touch. Moreover, "above", "above" and "above" the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. "Below", "beneath" and "beneath" the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply mean that the first feature is less horizontally than the second feature.
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present. As used herein, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions are for the purpose of illustration only and are not intended to represent the only embodiments.
如图1所示,本发明一实施例提供了一种支架输送装置10,该支架输送装置10包括:内管100、外管200、限位套管300及释放套管400;限位套管300、释放套管400套设于内管100的外部,外管200套设于限位套管300、释放套管400的外部,限位套管300位于释放套管400的远端侧。如图6所示,释放套管400的远端设置有束缚丝410,束缚丝410用于将支架800的裸段810束缚于限位套管300的外部,释放套管400能够在外力的作用下朝着外管200的近端运动直至束缚丝410解除对裸段810的束缚。As shown in Figure 1, an embodiment of the present invention provides a stent delivery device 10, the stent delivery device 10 includes: an inner tube 100, an outer tube 200, a limiting sleeve 300 and a releasing sleeve 400; the limiting sleeve 300 . The release sleeve 400 is sleeved on the outside of the inner tube 100 . The outer tube 200 is sleeved on the outside of the limiting sleeve 300 and the release sleeve 400 . The limiting sleeve 300 is located at the distal side of the release sleeve 400 . As shown in Figure 6, the distal end of the release sleeve 400 is provided with a binding wire 410, the binding wire 410 is used to bind the bare section 810 of the stent 800 to the outside of the limiting sleeve 300, the release sleeve 400 can be used under the action of external force Move downward toward the proximal end of the outer tube 200 until the tethering wire 410 unconstrains the bare segment 810 .
需要说明的是,支架输送装置的各个部件的远端是指部件中最先进入患者肝脏A1的一端,支架输送装置的各个部件的近端指的是靠近操作者的一端。It should be noted that the distal end of each component of the stent delivery device refers to the end of the components first entering the patient's liver A1, and the proximal end of each component of the stent delivery device refers to the end close to the operator.
该支架输送装置应用于医疗领域中,用来将医用支架输送至患者的病变部位。医用支架可以为肠道支架、血管支架等医用支架,其中血管支架可以为只包括裸段810的支架800,也可以包括裸段810与覆膜段820的TIP覆膜支架800。参见图1,图1中虚线所圈的部位为TIP覆膜支架800,裸段810的长度约为20mm,套设于限位套管300的外部,用于定位在门静脉中,保证门静脉向其他分支的血流灌注不受影响。覆膜段820的长度约为40mm~80mm,套设于释放套管400的外部,用于定位在肝脏实质中,有效防止胆汁侵蚀,其中裸段810与覆膜段820的交界处设置有显影环830,例如黄金显影环。具体地,参见图7,裸段810为网孔结构,包括沿轴向依次分布的多个支架段811,且相邻两个支架段811的顶点812互锁。包括覆膜段820的支架800包括沿轴向依次分布的多个支架段,且相邻两个支架段间隔分布并通过连接杆连接。下文便以TIP覆膜支架800为例就该支架输送装置10的材质、结构及工作过程给予一一描述。The stent delivery device is applied in the medical field, and is used to deliver the medical stent to the diseased part of the patient. The medical stent can be a medical stent such as an intestinal stent, a vascular stent, and the vascular stent can be a stent 800 including only a bare section 810 , or a TIP covered stent 800 including a bare section 810 and a covered section 820 . Referring to Fig. 1, the part circled by the dotted line in Fig. 1 is the TIP covered stent 800, the length of the bare section 810 is about 20mm, and it is sleeved on the outside of the position-limiting sleeve 300 for positioning in the portal vein to ensure Branch blood perfusion is not affected. The covered section 820 has a length of about 40 mm to 80 mm and is sheathed outside the release sleeve 400 for positioning in the liver parenchyma to effectively prevent bile erosion. Ring 830, such as a gold developer ring. Specifically, referring to FIG. 7 , the bare segment 810 is a mesh structure, including a plurality of stent segments 811 distributed sequentially along the axial direction, and the vertices 812 of two adjacent stent segments 811 are interlocked. The stent 800 including the covering segment 820 includes a plurality of stent segments distributed sequentially along the axial direction, and two adjacent stent segments are distributed at intervals and connected by connecting rods. The material, structure and working process of the stent delivery device 10 will be described below taking the TIP stent graft 800 as an example.
作为一种示例,该支架输送装置的内管100、外管200、限位套管300及释放套管400为具有生物形容性、安全性以及一定硬度的塑性材质,例如PE(Polyethene,聚乙烯)材质,该类材质可以满足支架输送装置在植入过程中自身可以随着血管进行相应弯曲的需求。另外,内管100、外管200、限位套管300及释放套管400均可为圆管。As an example, the inner tube 100, outer tube 200, limit sleeve 300 and release sleeve 400 of the stent delivery device are plastic materials with biodegradability, safety and certain hardness, such as PE (Polyethene, polyethylene ) material, which can meet the requirement that the stent delivery device itself can be bent correspondingly with the blood vessel during the implantation process. In addition, the inner tube 100, the outer tube 200, the limiting sleeve 300 and the releasing sleeve 400 can all be circular tubes.
作为一种示例,该释放套管400上的束缚丝410为具有生物形容性、安全性以及一定硬度的金属材质,例如镍钛材质。As an example, the tethering wire 410 on the release sleeve 400 is made of biodescriptive, safe and hard metal, such as nickel-titanium.
下面参考图8至图11对支架输送装置10的工作过程给予描述。The working process of the stent delivery device 10 will be described below with reference to FIGS. 8 to 11 .
应用时,先将TIP覆膜支架800装配至支架输送装置的外管200与内管100间所形成的支架容纳腔中。可具体为,先将TIP覆膜支架800套于内管100的外部并将TIP覆膜支架800的裸段810与限位套管300对齐;然后释放套管400的束缚丝410将裸段810束缚于限位套管300的外部;之后再将外管200套在内管100的外部,此时限位套管300、释放套管400及TIP覆膜支架800均装配至外管200内。需要说明的是,限位套管300、释放套管400和外管200的管壁之间均具有间隙,且该间隙的宽度大于或等于TIP覆膜支架800的壁厚,以容纳TIP覆膜支架800。In application, the TIP covered stent 800 is first assembled into the stent accommodating cavity formed between the outer tube 200 and the inner tube 100 of the stent delivery device. Specifically, the TIP stent-graft 800 is placed outside the inner tube 100 and the bare section 810 of the TIP stent-graft 800 is aligned with the limit sleeve 300; then the binding wire 410 of the sleeve 400 is released and the bare section 810 bound to the outside of the limiting sleeve 300 ; then the outer tube 200 is placed outside the inner tube 100 , and the limiting sleeve 300 , the releasing sleeve 400 and the TIP stent graft 800 are all assembled into the outer tube 200 . It should be noted that there is a gap between the walls of the limiting sleeve 300, the release sleeve 400 and the outer tube 200, and the width of the gap is greater than or equal to the wall thickness of the TIP stent graft 800 to accommodate the TIP graft. Bracket 800.
参见图8,临床植入时,支架输送装置10经患者的颈静脉入路进入下腔静脉A2,调整方向后进入肝右静脉A3,随后通过预先穿刺建立的人工通道导入门静脉A5。Referring to FIG. 8 , during clinical implantation, the stent delivery device 10 enters the inferior vena cava A2 through the patient's jugular vein approach, adjusts its direction, enters the right hepatic vein A3, and then introduces the portal vein A5 through the artificial channel established by puncture in advance.
参见图9及图10,待支架输送装置10进入门静脉A5指定位置后,将支架输送装置10整体回撤,待TIP覆膜支架800的显影环830与门静脉A5穿刺口完全重合,停止回撤。随后回撤外管200,待TIP覆膜支架800完全从外管200中释放出后停止,此时,TIP覆膜支架800的覆膜段820已经被释放在肝脏A1的穿刺通道A4中,但是TIP覆膜支架800的裸段810依然被束缚丝410束缚于限位套管300的外部。9 and 10, after the stent delivery device 10 enters the designated position of the portal vein A5, the stent delivery device 10 is withdrawn as a whole, and the withdrawal is stopped when the developing ring 830 of the TIP covered stent 800 completely overlaps with the puncture port of the portal vein A5. Then withdraw the outer tube 200, and stop after the TIP covered stent 800 is completely released from the outer tube 200. At this time, the covered segment 820 of the TIP covered stent 800 has been released in the puncture channel A4 of the liver A1, but The bare section 810 of the TIP stent-graft 800 is still bound by the binding wire 410 to the outside of the limiting sleeve 300 .
参见图11,随后朝着外管200的近端拉动释放套管400,束缚丝410跟随释放套管400整体向近端回撤,裸段810从束缚丝410的束缚中解脱出来,裸段810被释放于门静脉A5中,最后,从人体中撤出支架输送装置10。Referring to FIG. 11 , the release sleeve 400 is then pulled towards the proximal end of the outer tube 200, the binding wire 410 is withdrawn to the proximal end as a whole following the release sleeve 400, the bare section 810 is freed from the binding of the binding wire 410, and the bare section 810 is released in the portal vein A5, and finally, the stent delivery device 10 is withdrawn from the human body.
上述支架输送装置,在临床植入支架800时,束缚丝410可将支架800裸段810束缚于限位套管300的外部,从而对裸段810进行束缚。在先行释放支架800的覆膜段820时,裸段810自身便无法自膨展开,支架800也就无法“前跳”,可有效避免支架800由于“前跳”所导致的移位,进而可降低堵塞门静脉A5分支的风险,确保支架800精准释放。In the above-mentioned stent delivery device, when the stent 800 is clinically implanted, the binding wire 410 can bind the bare section 810 of the stent 800 to the outside of the limiting sleeve 300 , thereby binding the bare section 810 . When the coated section 820 of the stent 800 is released first, the bare section 810 cannot self-expand and expand, and the stent 800 cannot "jump forward", which can effectively avoid the displacement of the stent 800 due to "jump forward". Reduce the risk of blocking the A5 branch of the portal vein, and ensure accurate release of the stent 800 .
在本发明的一些实施例中,参见图2至图5,限位套管300沿自身近端至远端的方向设置有过丝孔310,限位套管300的外侧壁开设有与过丝孔310相通的限位槽320,束缚丝410可穿设于过丝孔310中且在外力的作用下能够从过丝孔310拉出。束缚丝410可穿设过丝孔310与裸段810的网孔中,从而将裸段810束缚于限位槽320中,进而起到束缚裸段810的作用。如此,限位槽320可以沿径向容纳一部分的裸段810,无需增大外管100的直径。In some embodiments of the present invention, referring to FIG. 2 to FIG. 5 , the limit sleeve 300 is provided with a wire passing hole 310 along the direction from its proximal end to the distal end, and the outer wall of the limit sleeve 300 is provided with a thread passing hole 310 . The hole 310 communicates with the limiting groove 320 , and the binding wire 410 can pass through the wire passing hole 310 and can be pulled out from the wire passing hole 310 under the action of an external force. The binding wire 410 can pass through the wire hole 310 and the mesh of the bare section 810 , so as to bind the bare section 810 in the limiting groove 320 , and further play the role of binding the bare section 810 . In this way, the limiting groove 320 can accommodate a part of the bare section 810 in the radial direction without increasing the diameter of the outer tube 100 .
需要说明的是,限位套管300的外侧壁是指限位套管300中与自身轴线平行的侧壁,并非指限位套管300的近端端面及远端端面。It should be noted that the outer wall of the limiting sleeve 300 refers to the side wall of the limiting sleeve 300 parallel to its own axis, not the proximal and distal end surfaces of the limiting sleeve 300 .
在本实施例中,如图2至图5所示,过丝孔310、限位槽320及束缚丝410的数量为多个,且一一对应。过丝孔310、限位槽320均沿限位套管300的周向均匀分布,束缚丝410沿释放套管400的周向均匀分布且沿轴向方向延伸。如此,可以对裸段810每个支架段811的各个顶点812进行有效束缚。其中过丝孔310、束缚丝410以及周向方向上一周的限位槽320的数量可与每一支架段811的顶点812数目相同,示例地,若每个支架段811具有6个顶点812,则过丝孔310、束缚丝410以及周向方向上一周的限位槽320的数量可均为6个。再示例地,每个支架段811具有12个顶点812,则过丝孔310、束缚丝410以及周向方向上一周的限位槽320的数量可均为12个。In this embodiment, as shown in FIG. 2 to FIG. 5 , there are multiple wire passing holes 310 , limiting grooves 320 and binding wires 410 , which correspond to each other. The wire passing holes 310 and the limiting grooves 320 are evenly distributed along the circumferential direction of the limiting sleeve 300 , and the binding wires 410 are evenly distributed along the circumferential direction of the releasing sleeve 400 and extend along the axial direction. In this way, each vertex 812 of each stent segment 811 of the bare segment 810 can be effectively constrained. The number of thread passing holes 310, binding wires 410, and limit grooves 320 in the circumferential direction may be the same as the number of vertices 812 of each bracket segment 811. For example, if each bracket segment 811 has 6 vertices 812, Then, the number of thread passing holes 310 , binding wires 410 , and the limiting slots 320 in one circle in the circumferential direction can all be six. As another example, each bracket segment 811 has 12 vertices 812 , so the number of thread passing holes 310 , binding wires 410 , and limiting slots 320 in the circumferential direction can all be 12.
在本实施例中,如图3及图5所示,过丝孔310为盲孔,即过丝孔310贯通限位套管300的近端,未贯通限位套管300的远端。如此,待束缚丝410穿过过丝孔310的近端及裸段810的网孔之后可限位于过丝孔310的近端中,可对裸段810进行有效束缚。In this embodiment, as shown in FIG. 3 and FIG. 5 , the wire passing hole 310 is a blind hole, that is, the wire passing hole 310 penetrates the proximal end of the limiting sleeve 300 but does not penetrate the distal end of the limiting sleeve 300 . In this way, after passing through the proximal end of the thread passing hole 310 and the mesh of the bare section 810 , the binding wire 410 can be confined in the proximal end of the thread passing hole 310 , and the bare section 810 can be effectively bound.
在本实施例中,如图2及图4所示,限位槽320与限位套管300的管腔330相通。如此设置,既可以保证限位槽320具有足够的空间对裸段810进行限位,也可以观察限位套管300与内管100是否装配到位。可选地,限位套管300与内管100可一体成型。In this embodiment, as shown in FIG. 2 and FIG. 4 , the limiting groove 320 communicates with the lumen 330 of the limiting sleeve 300 . Such arrangement can not only ensure that the limiting groove 320 has enough space to limit the bare section 810, but also can observe whether the limiting sleeve 300 and the inner tube 100 are assembled in place. Optionally, the limiting sleeve 300 and the inner tube 100 can be integrally formed.
在本实施例中,如图2及图4所示,限位槽320的数量为多个,且多个限位槽320在轴向和周向上均匀间隔设置。沿限位套管300的轴向间隔开设多个限位槽320,多个间断的槽结构可以保证限位套管300的强度。当然了,在其他一些实施例中,也可沿限位套管300的轴向连续开设一个限位槽320,单一连续的槽结构便于开设,应用时可以根据实际情况对限位槽320的结构进行具体设置。需要说明的是,当沿限位套管300的轴向开设多个限位槽320时,相邻的两个限位槽320的间距需要根据裸段810相邻两个支架段811的间距进行设定,否则裸段810的支架段811无法平顺地束缚在限位套管300的外表面上。作为一种示例,限位槽320可沿限位套管300的轴向分布,如此可以使得束缚丝410能够以更小的力度将裸段810限位于限位槽320中。In this embodiment, as shown in FIG. 2 and FIG. 4 , there are multiple limiting grooves 320 , and the plurality of limiting grooves 320 are evenly spaced in the axial and circumferential directions. A plurality of limiting grooves 320 are provided at intervals along the axial direction of the limiting sleeve 300 , and the structure of multiple discontinuous grooves can ensure the strength of the limiting sleeve 300 . Of course, in some other embodiments, a limit groove 320 can also be continuously opened along the axial direction of the limit sleeve 300. The single continuous groove structure is convenient to open, and the structure of the limit groove 320 can be adjusted according to the actual situation during application. Make specific settings. It should be noted that when multiple limiting grooves 320 are provided along the axial direction of the limiting sleeve 300, the distance between two adjacent limiting grooves 320 needs to be determined according to the distance between two adjacent bracket segments 811 of the bare segment 810. Otherwise, the bracket segment 811 of the bare segment 810 cannot be smoothly bound on the outer surface of the limiting sleeve 300 . As an example, the limiting grooves 320 may be distributed along the axial direction of the limiting sleeve 300 , so that the binding wire 410 can limit the bare section 810 in the limiting grooves 320 with less force.
在本发明的一些实施例中,如图6所示,释放套管400的近端设置有释放丝420,释放丝420能够在外力的作用下拉动释放套管400运动。待TIP覆膜支架800完全从外管200中释放出来后,拉动释放丝420,束缚丝410便跟随释放套管400整体向近端回撤,裸段810从束缚丝410的束缚中解脱出来,通过释放丝420的设置,便于裸段810的释放。其中,释放丝420的丝径可小于束缚丝410的丝径。可选地,释放丝420为具有生物形容 性、安全性以及一定硬度的金属材质,例如镍钛材质、不锈钢。关于释放丝420的数目,可以根据实际情况进行具体设置,例如设置1根、2根、3根等。In some embodiments of the present invention, as shown in FIG. 6 , a release wire 420 is provided at the proximal end of the release sleeve 400 , and the release wire 420 can pull the release sleeve 400 to move under the action of an external force. After the TIP covered stent 800 is completely released from the outer tube 200, the release wire 420 is pulled, and the tie wire 410 is retracted proximally along with the release sleeve 400 as a whole, and the bare section 810 is released from the bondage of the tie wire 410. The release of the bare segment 810 is facilitated by the arrangement of the release wire 420 . Wherein, the wire diameter of the releasing wire 420 may be smaller than that of the binding wire 410 . Optionally, the release wire 420 is made of a metal material with biodegradability, safety and certain hardness, such as nickel-titanium material, stainless steel. The number of release wires 420 can be specifically set according to actual conditions, for example, 1, 2, 3, etc. are set.
在本发明的一些实施例中,如图2至图5所示,限位套管300的近端形成有加强部340,加强部340的外壁为增磨结构;和/或,释放套管400的外壁为增磨结构。加强部340可以增大限位套管300的强度;另外,加强部340及释放套管400上的增磨结构,在TIP支架覆膜800的覆膜段820释放时,可以增大加强部340及释放套管400的外表面与覆膜段820的内表面间的摩擦作用,能够给TIP覆膜支架800释放提供一部分阻力,可有效减弱TIP覆膜支架800释放时“前跳”现象,保证TIP覆膜支架800释放位置精确。可以理解的是,过丝孔310贯穿至加强部340的近端端面。In some embodiments of the present invention, as shown in FIGS. 2 to 5 , a reinforced portion 340 is formed at the proximal end of the limiting sleeve 300 , and the outer wall of the reinforced portion 340 is a wear-increasing structure; and/or, the release sleeve 400 The outer wall is a wear-increasing structure. The reinforcement part 340 can increase the strength of the limiting sleeve 300; in addition, the increased wear structure on the reinforcement part 340 and the release sleeve 400 can increase the strength of the reinforcement part 340 when the coating section 820 of the TIP stent coating 800 is released. And the friction between the outer surface of the release sleeve 400 and the inner surface of the covered section 820 can provide a part of resistance to the release of the TIP covered stent 800, which can effectively weaken the "forward jump" phenomenon when the TIP covered stent 800 is released, ensuring The release position of the TIP stent graft 800 is precise. It can be understood that the wire hole 310 penetrates to the proximal end surface of the reinforcement part 340 .
可选地,增磨结构为磨砂结构。当然了,在其他的一些实施例中,也可以在加强部340及释放套管400的外壁上设置多个凸起来形成增磨结构。Optionally, the abrasive structure is a frosted structure. Certainly, in some other embodiments, a plurality of protrusions may also be provided on the outer walls of the reinforcement part 340 and the release sleeve 400 to form a wear-increasing structure.
如图1所示,支架输送装置10还包括可拆卸地连接于外管200远端端口处的锥形导头500,内管100的远端与锥形导头500连接。锥形导头500可以在支架输送装置的植入过程中起到导向的作用。可选地,锥形导头500通过过盈配合的方式装配至外管200远端端口处,如此便于外管200的回撤。As shown in FIG. 1 , the stent delivery device 10 further includes a tapered guide 500 detachably connected to the distal port of the outer tube 200 , and the distal end of the inner tube 100 is connected to the tapered guide 500 . The tapered guide head 500 can play a guiding role during the implantation process of the stent delivery device. Optionally, the tapered guide head 500 is fitted to the distal port of the outer tube 200 through an interference fit, which facilitates the retraction of the outer tube 200 .
如图1所示,支架输送装置10还包括:手柄(附图中未示出)、顶出头600以及弹性件700;手柄与外管200的近端连接,顶出头600与弹性件700设置于外管200内,顶出头600的远端用于与支架800的近端抵接,弹性件700的两端分别与手柄、顶出头600连接;内管100的近端穿出顶出头600与手柄连接。当回撤外管200时,覆膜段820的近端受到顶出头600远端的阻碍而被“顶”出外管200,待TIP覆膜支架800完全从外管200中释放出后停止,此时,覆膜段820已经被释放在肝脏A1的穿刺通道A4中。作为一种示例,顶出头600沿自身近端至远端的方向设置有通孔630,该通孔630用于走释放丝420。其中,该通孔630可沿顶出头600的轴向分布。As shown in Figure 1, the stent delivery device 10 also includes: a handle (not shown in the drawings), an ejection head 600 and an elastic member 700; the handle is connected to the proximal end of the outer tube 200, and the ejection head 600 and the elastic member 700 are arranged on Inside the outer tube 200, the distal end of the ejection head 600 is used to abut against the proximal end of the bracket 800, and the two ends of the elastic member 700 are respectively connected to the handle and the ejection head 600; the proximal end of the inner tube 100 passes through the ejection head 600 and the handle connect. When the outer tube 200 is withdrawn, the proximal end of the covering segment 820 is hindered by the distal end of the ejection head 600 and is "pushed" out of the outer tube 200. After the TIP covered stent 800 is completely released from the outer tube 200, it stops. , the covering segment 820 has been released in the puncture channel A4 of the liver A1. As an example, the ejection head 600 is provided with a through hole 630 along the direction from the proximal end to the distal end thereof, and the through hole 630 is used for releasing the release wire 420 . Wherein, the through holes 630 may be distributed along the axial direction of the ejection head 600 .
可选地,弹性件700可以为弹簧,弹性件主要是能够是为了便于支架输送装置的前端适应弯曲的血管。其中,如图12所示,顶出头600的近端设置有弹性件安装凸台620,弹性件700的远端可以套于弹性件安装凸台620上。弹性件安装凸台620具有走管孔,内管100的近端穿出走管孔与手柄连接。内管100的近端穿出弹性件安装凸台620,之后穿出弹性件700与手柄连接。Optionally, the elastic member 700 may be a spring, and the elastic member is mainly to facilitate the front end of the stent delivery device to adapt to a curved blood vessel. Wherein, as shown in FIG. 12 , the proximal end of the ejector head 600 is provided with an elastic member installation boss 620 , and the distal end of the elastic member 700 can be sleeved on the elastic member installation boss 620 . The elastic member installation boss 620 has a tube hole, and the proximal end of the inner tube 100 passes through the tube hole to be connected with the handle. The proximal end of the inner tube 100 passes through the elastic member installation boss 620, and then passes through the elastic member 700 to be connected with the handle.
可选地,顶出头600的远端设置有支架安装凸台610。TIP覆膜支架800的覆膜段820的近端套于支架安装凸台610的外部。Optionally, the distal end of the ejection head 600 is provided with a bracket installation boss 610 . The proximal end of the covered segment 820 of the TIP covered stent 800 is sleeved on the outside of the bracket installation boss 610 .
在其他实施例中,释放套管400的远端设置有束缚丝410,释放套管400的外径大于限位套管300的外径,从而束缚丝410可以将支架的裸段束缚于限位套管的外部。In other embodiments, the distal end of the release sleeve 400 is provided with a binding wire 410, and the outer diameter of the release sleeve 400 is larger than the outer diameter of the limiting sleeve 300, so that the binding wire 410 can bind the bare segment of the stent in a limited position. outside of the casing.
本发明另一实施例提供了一种支架输送系统,该支架输送系统包括支架800以及上述任一项向所述的支架输送装置10。支架输送装置10的束缚丝410用于将支架800的裸段810束缚于支架输送装置10的限位套管300的外部,释放套管400能够在外力的作用下朝着外管200的近端运动直至束缚丝410解除对裸段810的束缚。Another embodiment of the present invention provides a stent delivery system, which includes a stent 800 and any one of the above-mentioned stent delivery devices 10 . The binding wire 410 of the stent delivery device 10 is used to bind the bare section 810 of the stent 800 to the outside of the limit sleeve 300 of the stent delivery device 10, and the release sleeve 400 can move towards the proximal end of the outer tube 200 under the action of external force. Move until the tethering wire 410 unbinds the bare segment 810 .
作为一种示例,支架可以为肠道支架、血管支架等医用支架,其中血管支架可以为只包括裸段的支架,也可以包括裸段与覆膜段的TIP覆膜支架。参见图1,图1中虚线所圈的部位为TIP覆膜支架800,裸段810的长度约为20mm,套设于限位套管300的外部,用于定位在门静脉中,保证门静脉向其他分支的血流灌注不受影响。覆膜段820的长度约为40mm~80mm,套设于释放套管400的外部,用于定位在肝脏实质中,有效防止胆汁侵蚀,其中裸段810与覆膜段820的交界处设置有显影环830,例如黄金显影环。具体地,参见图7,裸段810为网孔结构,包括沿轴向依次分布的多个支架段811,且相邻两个支架段811的顶点812互锁;覆膜段820的支架800包括沿轴向依次分布的多个支架段,且相邻两个支架段间隔分布并通过连接杆连接。As an example, the stent may be a medical stent such as an intestinal stent or a blood vessel stent, wherein the blood vessel stent may be a stent including only a bare segment, or a TIP covered stent including a bare segment and a covered segment. Referring to Fig. 1, the part circled by the dotted line in Fig. 1 is the TIP covered stent 800, the length of the bare section 810 is about 20mm, and it is sleeved on the outside of the position-limiting sleeve 300 for positioning in the portal vein to ensure Branch blood perfusion is not affected. The covered section 820 has a length of about 40 mm to 80 mm and is sheathed outside the release sleeve 400 for positioning in the liver parenchyma to effectively prevent bile erosion. Ring 830, such as a gold developer ring. Specifically, referring to FIG. 7 , the bare segment 810 is a mesh structure, including a plurality of stent segments 811 distributed sequentially along the axial direction, and the vertices 812 of two adjacent stent segments 811 are interlocked; the stent 800 of the covered segment 820 includes A plurality of stent segments are distributed sequentially along the axial direction, and two adjacent stent segments are distributed at intervals and connected by connecting rods.
上述支架800输送系统,在临床植入支架800时,束缚丝410可将膜支架800的裸段810束缚于限位套管300的外部,从而对裸段810进行束缚,在先行释放支架800的覆膜段820时,裸段810便自身无法自膨展开,支架800也就无法“前跳”,可有效避免支架800由于“前跳”所导致的移位,进而可降低堵塞门静脉A5分支的风险,确保支架800精准释放。The stent 800 delivery system mentioned above, when the stent 800 is clinically implanted, the tethering wire 410 can bind the bare section 810 of the membrane stent 800 to the outside of the spacer sleeve 300, thereby constraining the bare section 810, and releasing the stent 800 first. When the coated section 820 is used, the bare section 810 cannot self-expand, and the stent 800 cannot "jump forward", which can effectively avoid the displacement of the stent 800 due to "jump forward", thereby reducing the chance of blocking the A5 branch of the portal vein. risk, ensure accurate release of the stent 800.
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be noted that, for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims (15)

  1. 一种支架输送装置(10),用于输送支架(800),其特征在于,包括:内管(100)、外管(200)、限位套管(300)及释放套管(400);A stent delivery device (10), used to deliver a stent (800), characterized by comprising: an inner tube (100), an outer tube (200), a limiting sleeve (300) and a releasing sleeve (400);
    所述限位套管(300)、所述释放套管(400)套设于所述内管(100)的外部,所述外管(200)套设于所述限位套管(300)、所述释放套管(400)的外部,所述限位套管(300)位于所述释放套管(400)的远端侧;The limiting sleeve (300) and the releasing sleeve (400) are sleeved on the outside of the inner tube (100), and the outer tube (200) is sleeved on the limiting sleeve (300) . The outside of the release sleeve (400), the limit sleeve (300) is located on the distal side of the release sleeve (400);
    所述释放套管(400)的远端设置有束缚丝(410),所述束缚丝(410)用于将支架(800)的裸段(810)束缚于所述限位套管(300)的外部,所述释放套管(400)设置为在外力的作用下朝着所述外管(200)的近端运动直至所述束缚丝(410)解除对所述裸段(810)的束缚。The distal end of the release sleeve (400) is provided with a binding wire (410), and the binding wire (410) is used to bind the bare section (810) of the stent (800) to the limit sleeve (300) The release sleeve (400) is set to move towards the proximal end of the outer tube (200) under the action of an external force until the binding wire (410) releases the binding of the bare segment (810) .
  2. 根据权利要求1所述的支架输送装置,其特征在于,所述限位套管(300)沿自身近端至远端的方向设置有过丝孔(310),所述限位套管(300)的外侧壁开设有与所述过丝孔(310)相通的限位槽(320);The stent delivery device according to claim 1, characterized in that, the limit sleeve (300) is provided with a wire hole (310) along the direction from the proximal end to the distal end thereof, and the limit sleeve (300) ) is provided with a limiting groove (320) communicating with the wire passing hole (310) on the outer side wall;
    所述束缚丝(410)可穿设于所述过丝孔(310)中且设置为在外力的作用下能够从所述过丝孔(310)拉出。The binding wire (410) can pass through the wire passing hole (310) and is configured to be able to be pulled out from the wire passing hole (310) under the action of an external force.
  3. 根据权利要求2所述的支架输送装置,其特征在于,所述过丝孔(310)、所述限位槽(320)及所述束缚丝(410)的数量为多个,且一一对应;The stent delivery device according to claim 2, characterized in that the number of the wire passing holes (310), the limiting grooves (320) and the binding wires (410) are multiple, and correspond to each other ;
    所述过丝孔(310)、所述限位槽(320)均沿所述限位套管(300)的周向均匀分布且沿轴向方向延伸,所述束缚丝(410)沿所述释放套管(400)的周向均匀分布且沿轴向方向延伸。The wire passing holes (310) and the limiting grooves (320) are evenly distributed along the circumferential direction of the limiting sleeve (300) and extend along the axial direction, and the binding wire (410) is along the The release sleeves (400) are evenly distributed circumferentially and extend in the axial direction.
  4. 根据权利要求2所述的支架输送装置,其特征在于,所述过丝孔(310)为盲孔。The stent delivery device according to claim 2, characterized in that, the wire passing hole (310) is a blind hole.
  5. 根据权利要求2所述的支架输送装置,其特征在于,所述限位槽(320)与所述限位套管(300)的管腔(330)相通。The stent delivery device according to claim 2, characterized in that, the limiting groove (320) communicates with the lumen (330) of the limiting sleeve (300).
  6. 根据权利要求2所述的支架输送装置,其特征在于,所述限位套管(300)的外侧壁沿轴向和周向分别开设有多个所述限位槽(320),多个所述限位槽(320)在轴向和周 向上均匀间隔分布。The stent delivery device according to claim 2, characterized in that, the outer wall of the limiting sleeve (300) is respectively provided with a plurality of limiting grooves (320) in the axial direction and in the circumferential direction, and the plurality of limiting grooves (320) The limiting slots (320) are evenly distributed in the axial and circumferential directions.
  7. 根据权利要求1所述的支架输送装置,其特征在于,所述释放套管(400)的近端设置有释放丝(420),所述释放丝(420)设置为能够在外力的作用下拉动所述释放套管(400)运动。The stent delivery device according to claim 1, characterized in that, the proximal end of the release sleeve (400) is provided with a release wire (420), and the release wire (420) is configured to be able to be pulled under the action of an external force The release sleeve (400) moves.
  8. 根据权利要求1所述的支架输送装置,其特征在于,所述限位套管(300)的近端形成有加强部(340);所述加强部(340)和所述释放套管(400)至少一个的外壁为增磨结构。The stent delivery device according to claim 1, characterized in that, a reinforcing part (340) is formed at the proximal end of the limiting sleeve (300); the reinforcing part (340) and the releasing sleeve (400) ) at least one outer wall is a wear-increasing structure.
  9. 根据权利要求1-8任一项所述的支架输送装置,所述支架输送装置(10)还包括可拆卸地连接于所述外管(200)远端端口处的锥形导头(500),所述内管(100)的远端与所述锥形导头(500)连接。The stent delivery device according to any one of claims 1-8, the stent delivery device (10) further comprising a tapered guide (500) detachably connected to the distal port of the outer tube (200) , the distal end of the inner tube (100) is connected with the tapered guide (500).
  10. 根据权利要求1-8任一项所述的支架输送装置,所述支架输送装置(10)还包括:手柄、顶出头(600)以及弹性件(700);The stent delivery device according to any one of claims 1-8, the stent delivery device (10) further comprising: a handle, an ejection head (600) and an elastic member (700);
    所述手柄与所述外管(200)的近端连接,所述顶出头(600)与所述弹性件(700)设置于所述外管(200)内,所述顶出头(600)的远端用于与所述支架(800)的近端抵接,所述弹性件(700)的两端分别与所述手柄、所述顶出头(600)连接;The handle is connected to the proximal end of the outer tube (200), the ejector head (600) and the elastic member (700) are arranged in the outer tube (200), and the ejector head (600) The distal end is used to abut against the proximal end of the bracket (800), and the two ends of the elastic member (700) are respectively connected to the handle and the ejection head (600);
    所述内管(100)的近端穿出所述顶出头(600)与所述手柄连接。The proximal end of the inner tube (100) passes through the ejector head (600) and is connected with the handle.
  11. 根据权利要求10所述的支架输送装置,其特征在于,所述顶出头(600)的远端设置有支架安装凸台(610),和/或所述顶出头(600)的近端设置有弹性件安装凸台(620)。The stent delivery device according to claim 10, characterized in that, the distal end of the ejection head (600) is provided with a bracket installation boss (610), and/or the proximal end of the ejection head (600) is provided with The elastic member is installed with the boss (620).
  12. 根据权利要求11所述的支架输送装置,其特征在于,所述弹性件安装凸台(620)具有走管孔,所述内管(100)的近端穿出所述走管孔与所述手柄连接。The stent delivery device according to claim 11, characterized in that, the elastic member installation boss (620) has a tube hole, and the proximal end of the inner tube (100) passes through the tube hole and the tube hole. Handle connection.
  13. 根据权利要求3所述的支架输送系统,其特征在于,所述裸段(810)为网孔结构,包括沿轴向依次分布的多个支架段(811),相邻两个支架段(811)的顶点(812)互锁。The stent delivery system according to claim 3, wherein the bare segment (810) is a mesh structure, comprising a plurality of stent segments (811) distributed sequentially along the axial direction, and two adjacent stent segments (811) ) vertices (812) are interlocked.
  14. 根据权利要求13所述的支架输送系统,其特征在于,所述过丝孔(310)的数量,所述束缚丝(410)的数量,以及周向方向上一周的所述限位槽(320)的数量,与每一支架段(811)的顶点(812)数目相同。The stent delivery system according to claim 13, characterized in that, the number of the wire passing holes (310), the number of the binding wires (410), and the limiting groove (320) in the circumferential direction ) is the same as the number of vertices (812) of each stent segment (811).
  15. 一种支架输送系统,其特征在于,包括支架(800)以及如权利要求1-14任一项所述的支架输送装置(10)。A stent delivery system, characterized by comprising a stent (800) and the stent delivery device (10) according to any one of claims 1-14.
PCT/CN2022/126976 2021-12-14 2022-10-24 Stent delivery device and stent delivery system WO2023109315A1 (en)

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