CN108143447B - Aortic dissection distal end breach plugging device - Google Patents

Aortic dissection distal end breach plugging device Download PDF

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Publication number
CN108143447B
CN108143447B CN201711431365.XA CN201711431365A CN108143447B CN 108143447 B CN108143447 B CN 108143447B CN 201711431365 A CN201711431365 A CN 201711431365A CN 108143447 B CN108143447 B CN 108143447B
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bare stent
bare
distal
tube
disc
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CN108143447A (en
Inventor
马连彩
许尚栋
崔跃
张宝祥
于学保
李君涛
刘冰
尚再艳
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Beijing Tuoyi Medical Technology Service Co.,Ltd.
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Individual
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623Introducing or retrieving devices therefor

Abstract

The invention discloses an aortic dissection distal laceration plugging device which comprises a naked stent system and a plugging device. The bare bracket is accurately positioned and released by the bare bracket dispenser, and the axial length of the bare bracket can be limited and fixed by the limiting rod; the stopper consists of a large disc, a small disc and a short waist, wherein the large disc and the small disc are both arc-shaped when viewed from top, a circle of hooks pointing to the circle center are arranged on the inner side of the small disc, the cross section of the short waist is different in shape, and the contact surface of the short waist and the large disc is sewn and wrapped by flexible blood-impermeable materials. The invention is used for plugging the distal laceration of the aortic dissection, can match the shape of the dissection laceration, reduces the occurrence of internal leakage and the risk of falling off of the plugging device, can reduce the damage of the large and small disks to the inner wall of the blood vessel, can adapt to the pathological structure of the branch blood vessel near the laceration, and reduces the physical damage of the large disk positioned in the false cavity to the inner wall of the false cavity.

Description

Aortic dissection distal end breach plugging device
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to an aortic dissection distal laceration plugging device.
Background
At present, aortic diseases become cardiovascular diseases seriously threatening human health, wherein aortic dissection is a more catastrophic disease, and refers to a true-false two-lumen separation state that blood in an aortic lumen enters an aortic media from a torn part of the aortic media to separate the aortic media and expands along the major axis of the aorta to form an aortic wall.
At present, the aortic dissection for minimally invasive interventional therapy has been widely applied clinically due to the advantages of small trauma, short operation time and small blood transfusion amount. However, the aortic dissection usually has a plurality of lacerations distributed beside the important branch artery, the intraluminal treatment covers the first laceration with a stent-type artificial blood vessel to prevent blood from entering the false lumen, and reduces the pressure in the false lumen, so as to prevent thrombosis of the false lumen, but because the distal lacerations are not closed, there are still risks of blood reflux, long-term non-healing of the postoperative distal false lumen, and rupture caused by continuous enlargement of the false lumen.
In recent years, clinical attempts have been made to use an atrioventricular septal defect occluder to occlude the distal laceration. The commonly used occluder comprises double discs and a waist, wherein the double discs of the occluder are respectively arranged in the true and false cavities during use, the middle waist straddles the lacerated opening, and the filler in the double discs is used for blood occlusion. However, the method still has the following defects:
1. the shapes and sizes of the far-end crevasses of the interlayers are different and are usually presented in the shapes of a circle, a diamond, a triangle, a trapezoid and the like, the designed shape of the connecting waist of the left and right discs of the existing occluder is not matched with the crevasses, and gaps still exist at the connecting waist for blood to pass through;
2. the plugging device is not anchored enough on the interlayer inner membrane, and still has the risks of falling off, untight plugging of a crevasse and the like;
3. the double discs of the common occluder are in a plane circular shape, and the risk of physical injury of the inner wall of a long-term blood vessel caused by mismatching of the shape of the lumen structure of the blood vessel of a human body exists.
Disclosure of Invention
In order to solve the problems, the invention provides an aortic dissection distal end breach plugging device with a novel structure, which aims to solve the problems that a distal end breach of an aortic dissection is arranged in an open manner, a false cavity is not easy to form thrombus due to reverse blood flow, and the like, so that an accurate and effective breach plugging effect is achieved. Meanwhile, the invention also provides a releasing device which is used for solving the problems that the existing clinical grid woven support cannot be accurately positioned, the radial supporting force is small and the like.
In order to realize the purpose, the invention provides the following technical scheme:
an aortic dissection distal laceration plugging device comprises a bare stent system 1 and a plugging device 7, wherein the bare stent system 1 comprises a bare stent 101 and a limiting rod 102; the bare stent 101 is a net structure formed by metal wires; the far end of the limiting rod 102 is flush and fixedly connected with the far end of the bare stent 101, the near end of the limiting rod 102 is hooked on a metal wire at the near end of the bare stent 101 through a barb, the length of the bare stent 101 is limited through the fixed length of the limiting rod 102, and the bare stent 101 is ensured not to be axially elongated in a narrow true lumen of an aortic dissection so as to provide enough radial supporting force to expand the true lumen and reduce a false lumen; the occluder 7 comprises a small disc 701, a hook 702, a large disc 703, a short waist 704 and a linear mark 705; the short waist 704 spans over the metal wire of the bare stent 101, and two ends of the short waist are fixedly connected with the small disc 701 and the large disc 703 respectively, wherein the small disc 701 is positioned on the inner side of the bare stent 101, and the large disc 703 is positioned on the outer side of the bare stent 101; the linear mark 705 made of an X-ray opaque material is arranged at the edge of the connection surface between the large disk 703 and the small disk 701 and at the edge of the connection surface between the large disk 703 and the short waist 704; one side of the short waist 704 of the small disc 701 is provided with a circle of hooks 702 extending in the opposite direction of the disc center, the hooks 702 are semicircular and tangent to the disc surface of the small disc 701, and the hooks 702 hook the metal wires of the bare bracket 101.
Further, the diameter of the metal wire of the bare stent 101 is 0.2-0.6 mm; the limiting rod 102 is made of a hard material and has a length of 20-100 mm.
Furthermore, the plugging device 7 is a net structure formed by metal wires with the wire diameter of 0.2-0.6 mm; the diameters of the large disc 703 and the small disc 701 are 10-25 mm, and the diameter of the large disc 703 is not smaller than that of the small disc 701; the length of the short waist 704 is 2-5 mm.
Further, the section of the short waist 704 is circular, rhombic, triangular or trapezoidal, the short waist 704 is in arc transition connection with the large disc 703 and the small disc 701, and flexible blood-impermeable materials are sewn and wrapped on the cross sections of the short waist 704, the large disc 703 and the small disc 701.
Further, the center of the short waist 704 is concentrically disposed with the small disc 701, and the short waist 704 is concentrically disposed with the large disc 703 or non-concentrically disposed.
Further, the occlusion device further comprises a bare stent dispenser, the bare stent system 1 is conveyed and released by the bare stent dispenser, the bare stent dispenser comprises a pull-back line control device 2, a core tube system 3, a bare stent proximal end control device 4, a bare stent distal end control device 5 and an outer sheath tube system 6, wherein the pull-back line control device 2 comprises a pull-back line 201, a pull-back line double-layer tube 202 and a pull-back line handle 203, the core tube system 3 comprises a guide head 301, a core tube 302 and a core tube handle 303, the bare stent proximal end control device 4 comprises a bare stent proximal end fixing needle 401, a bare stent proximal end fixing cap 402, a bare stent proximal end control rod 403, a bare stent proximal end limiting pin 404 and a bare stent proximal end control handle 405, and the bare stent distal end control device 5 comprises a bare stent distal end pressing tube 501, a bare stent distal end filling tube 502, a bare stent distal end limiting pin 503, a bare stent distal, A bare stent distal end pressing tube handle 504 and a bare stent distal end filling tube handle 505, and the outer sheath tube system 6 comprises an outer sheath tube 601 and an outer sheath tube handle 602.
Further, the pull-back line 201 is located in the pull-back line double-layer tube 202 and connected to the pull-back line handle 203, the outer side of the pull-back line double-layer tube 202 is sleeved with the sheath tube 601, the end point of the pull-back line 201 is connected to the barb of the limiting rod 102, and the pull-back line 201 and the barb of the limiting rod 102 are controlled to release from each other in the pull-back direction.
Further, the guide head 301 is connected to the bare stent proximal fixing needle 401, and the bare stent proximal fixing needle 401 is inserted into a corresponding hole of the bare stent proximal fixing cap 402 to hook the proximal end of the bare stent 101; the bare stent proximal end limiting pin 404 penetrates through the tube wall of the bare stent proximal end control rod 403 and extends into part of the tube wall of the core tube 302; when the bare stent proximal end limiting pin 404 is pulled out, the bare stent proximal end control handle 405 is pulled down, and the bare stent proximal end fixing needle 401 is released to release the proximal end of the bare stent 101.
Further, the distal end of the bare stent 101 is tightly pressed between the bare stent proximal control rod 403 and the bare stent distal pressure tube 501, and is adjacent to the bare stent distal filling tube 502; the bare stent far-end limiting pin 503 penetrates through the tube wall of the bare stent far-end pressing tube 501 and the tube wall of the bare stent far-end filling tube 502 and extends into the tube wall of the bare stent near-end control rod 403; when the bare stent distal end limiting pin 503 is pulled out to the tube wall position of the bare stent distal end filling tube 502, the relative positions of the bare stent distal end filling tube 502 and the bare stent distal end pressing tube 501 are fixed, and the bare stent 101 is driven to move forward by pushing forward; when the bare stent distal end limiting pin 503 is completely pulled out, the bare stent distal end pressing tube handle 504 is pulled down to drive the bare stent distal end pressing tube 501, so as to release the distal end of the bare stent 101.
Further, the plugging device is used by one bare stent system 1 in cooperation with a plurality of plugging devices 7 for plugging a plurality of distal lacerations.
The invention discloses an aortic dissection distal laceration plugging device, which has the beneficial effects that: 1. the length of the naked stent is controllable. The length of the bare support can be controlled through the limiting rod and the limiting rod barb, so that the bare support is compressed to the length of the limiting rod, and the bare support is prevented from being excessively elongated and being incapable of providing enough radial supporting force;
2. the bare stent is accurately positioned. The near-end and far-end control devices of the bare stent delivery device can realize the adjustment of the axial position of the bare stent at any time in the release process, and realize the accurate release.
3. The stopper is firmly anchored. And (3) implanting the occluder after releasing the bare stent, wherein the anchoring hooks on the inner side of the small disk of the occluder can hook the metal wires on the four sides of the diamond hole of the bare stent, so as to prevent the small disk of the occluder from falling into the false cavity.
4. Is suitable for different crevasses and morphological structures. The shape of the short waist section of the plugging device can be selected according to the shape of the crevasse so as to adapt to crevasses with different shapes; for the laceration positioned near the branch arteries such as renal artery, mesenteric artery and the like, the relative position between the large disc and the short waist of the used occluder can be determined according to the actual situation. So as to reduce the complications of falling off, untight sealing and the like caused by the mismatching of the design shape.
5. Adapting to the vascular tubular structure. The large disc and the small disc of the occluder are arc-shaped in plan view, the arc radius of the occluder is determined according to the radius of the implanted aorta, and the risk of damage to the inner wall of the blood vessel caused by the mismatching of the shapes of the large disc, the small disc and the arc-shaped lumen can be reduced.
6. And a good plugging effect can be realized. The short waist side surface and the left and right cross sections of the occluder are wrapped in a sealing mode by flexible blood impermeable materials, and the occluders with different shapes and short waists are used for the crevasses with different shapes, so that blood in the false cavity is prevented from flowing into the true cavity from the crevasses to the greatest extent, and a good occlusion effect is achieved.
Drawings
FIG. 1 is a schematic view of a combination of a bare stent and an occluder of an aortic dissection distal laceration occlusion device of the present invention;
fig. 2 is a combined top view of a bare stent and an occluder of an aortic dissection distal laceration occlusion device of the invention, wherein fig. 2(a) is an overall top view, and fig. 2(b) is a partial enlarged view of a combined part of the bare stent and the occluder;
fig. 3 is a schematic structural view of a short lumbar cylindrical surface of an occluder of an aortic dissection distal end rupture occluding device of the present invention in a diamond shape;
FIG. 4 is a schematic structural diagram of an occluder of an aortic dissection distal breach occluding device according to the present invention when the aortic dissection distal breach is located near the branch artery opening;
FIG. 5 is an overall schematic view of a bare stent dispenser of an aortic dissection distal breach closure device of the present invention;
FIG. 6 is a schematic view of a control device for a pullback wire of a bare stent delivery device of an aortic dissection distal breach occlusion device of the present invention;
FIG. 7 is a schematic view of a proximal control device of a bare stent delivery device of an aortic dissection distal breach occlusion device of the present invention;
FIG. 8 is a schematic view of a bare stent distal control device of a bare stent delivery device of an aortic dissection distal breach occlusion device of the present invention;
FIG. 9 is a schematic diagram of the movement process of the retraction wire traction limiting rod of the aortic dissection distal laceration occlusion device of the present invention;
description of reference numerals:
1-bare stent system, 101-bare stent, 102-limiting rod, 2-pullback wire control device, 201-pullback wire, 202-pullback wire double-layer tube, 203-pullback wire handle, 3-core tube system, 301-guide head, 302-core tube, 303-core tube handle, 4-bare stent proximal end control device, 401-bare stent proximal end fixing needle, 402-bare stent proximal end fixing cap, 403-bare stent proximal end control rod, 404-bare stent proximal end limiting pin, 405-bare stent proximal end handle, 5-bare stent distal end control device, 501-bare stent distal end pressing tube, 502-bare stent distal end filling tube, 503-bare stent distal end limiting pin, 504-bare stent distal end pressing tube handle, 505-bare stent distal end filling tube handle, 6-sheath system, 601-sheath system, 602-sheath handle, 7-occluder, 701-small disk, 702-hook, 703-large disk, 704-short waist, 705-linear marker, 8-aortic dissection true cavity, 9-aortic dissection false cavity, 10-branch artery.
Detailed Description
In order to make the implementation objects, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be described in more detail below with reference to the accompanying drawings in the embodiments of the present invention. In the drawings, the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The described embodiments are only some, but not all embodiments of the invention. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The "proximal" and "distal" directions are described below as the direction of blood flow in the aorta from the proximal to the distal position.
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
The invention discloses an aortic dissection distal laceration plugging device which mainly comprises a naked stent system 1 and a plugging device 7. Wherein the content of the first and second substances,
as shown in fig. 1, the bare stent system 1 includes a bare stent 101 and a stopper rod 102, wherein,
the bare support 101 is a net-shaped structure formed by metal wires, 2-4 limiting rods 102 are axially and uniformly distributed on the inner side of the bare support 101, the far end of each limiting rod 102 is flush and fixedly connected with the far end of the bare support 101, and the near end of each limiting rod 102 is hooked on the metal wire on the near end of the bare support 101 through a barb, so that the length of the bare support 101 is limited through the fixed length of the limiting rods 102, the bare support 101 is ensured not to be axially elongated in a narrow true cavity of an interlayer, and sufficient radial supporting force is provided to expand the true cavity and reduce a false cavity;
the metal wire of the bare stent 101 can be a memory metal wire, the wire diameter is 0.2-0.6 mm, and the mesh structure can be arranged into a diamond shape, for example;
the limiting rod 102 is made of a hard material and has a length of 20-100 mm. The occluding device 7 comprises a small disc 701, a hook 702, a large disc 703, a short waist 704 and a line-like mark 705, wherein,
the short waist 704 spans over the metal wire of the bare bracket 101, and two ends of the short waist are fixedly connected with the small disc 701 and the large disc 703 respectively, wherein the small disc 701 is positioned at the inner side of the bare bracket 101, and the large disc 703 is positioned at the outer side of the bare bracket 101;
the edges of the connection surfaces of the large disk 703 and the small disk 701 and the edges of the connection surfaces of the large disk 703 and the short waist 704 are provided with linear marks 705 made of X-ray opaque materials;
one side of the short waist 704 of the small disc 701 is provided with a circle of hooks 702 extending reversely to the disc center, the shape of the hooks 702 is arranged to be semicircular arc and tangent to the disc surface of the small disc 701, and the hooks 702 hook the metal wire of the bare bracket 101, so that the small disc 701 is prevented from crossing the rhombic meshes through the short waist 704 and slipping off; the diameter of the inner curved side of the hook 702 is the same as the wire diameter of the wire of the bare stent 101;
the number of the hooks 702 can be set to be 4-8, and the hooks are uniformly distributed along the circumference;
the same as the naked stent 101, the occluder 7 can be a net structure formed by metal wires, and the diameter of the wires can be set to be 0.2-0.6 mm;
the large disc 703 and the small disc 701 are both circular, and the diameter of the large disc 703 is not smaller than that of the small disc 701;
the diameter range of the large disc 703 and the small disc 701 is 10-25 mm, and the length of the short waist 704 is 2-5 mm.
As shown in fig. 2(a), it is a top view of the bare stent system 1 in cooperation with the occluder 7; as shown in fig. 2(b), a partial enlarged view of the occluder 7 is shown, in which a large disk 703 and a small disk 701 are provided as concentric arcs. When the blood-permeable short waist part 704 is used cooperatively, the short waist part 704 is arranged into a columnar structure, and flexible blood-impermeable materials are sewn and wrapped on the cylindrical surface and the cross section in contact with the large disc 703 and the small disc 701;
the section of the short waist 704 can be set into different shapes, including circle, diamond, triangle, trapezoid, etc., the short waist 704 and the large disc 703 and the small disc 701 are connected in an arc transition manner, the design can enable the crevasse plugging device to be more attached to the circular vascular lumen, and the planar shape of the plugging device is prevented from damaging the vascular intima.
In a preferred embodiment of the invention, as shown in fig. 3, the cross-section of the short waist 704 is configured as a diamond for use with a diamond-shaped distal dissection of the aortic dissection. Similarly, the four rhombic cylindrical surfaces of the short waist 704 and the two contact surfaces of the large disc 703 and the small disc 701 are respectively sewn and wrapped with flexible blood-impermeable materials, so that the far-end laceration of the interlayer can be completely plugged.
In this embodiment, the center of the short waist 704 is concentrically disposed with both the large disk 703 and the small disk 701. In another preferred embodiment of the invention, shown in figure 4, the distal dissection of the aortic dissection is located in the vicinity of the branch artery above it, with the short waist 704 of the occluder 7 lying at the edge of the disk face of the large disk 703, ensuring that the centre of the large disk 703 lies above the dissection in use. The large disc 703 is positioned in the false cavity 9, the small disc 701 is positioned in the true cavity 8, and the hook 702 on the small disc 701 hooks the rhombic net-shaped memory metal wire of the bare stent 101 to realize position fixation.
In this embodiment, the short waist 704 is concentric with the small disc 701 and is located at a position below the large disc 703, i.e. is not concentrically disposed.
Fig. 5-8 are schematic views of a bare stent dispenser of an aortic dissection distal breach occlusion device of the present invention.
Fig. 5 is an overall schematic view of a bare stent presenter. The bare stent system 1 is delivered and released by the bare stent dispenser, which mainly comprises a back-drawing wire control device 2, a core tube system 3, a bare stent proximal end control device 4, a bare stent distal end control device 5, an outer sheath tube system 6, and the like, wherein,
the pull-back wire control device 2 comprises a pull-back wire 201, a pull-back wire double-layer tube 202 and a pull-back wire handle 203;
the core tube system 3 comprises a guide head 301, a core tube 302 and a core tube handle 303;
the bare stent proximal control device 4 comprises a bare stent proximal fixing needle 401, a bare stent proximal fixing cap 402, a bare stent proximal control rod 403, a bare stent proximal limit pin 404 and a bare stent proximal control handle 405;
the bare stent distal end control device 5 comprises a bare stent distal end pressing tube 501, a bare stent distal end filling tube 502, a bare stent distal end limiting pin 503, a bare stent distal end pressing tube handle 504 and a bare stent distal end filling tube handle 505;
the outer sheath catheter system 6 includes an outer sheath catheter 601 and an outer sheath catheter handle 602.
Fig. 6 is a schematic view of the control device for the pullback wire of the bare stent dispenser. The diameter of the pull-back wire 201 is 0.1-0.3 mm, and the pull-back wire is positioned in the pull-back wire double-layer pipe 202 and connected with the pull-back wire handle 203. The distance between two lumens of the double-layer tube 202 of the pull-back line is slightly larger than the line diameter of the pull-back line 201, and the outer side of the double-layer tube is sleeved with the outer sheath tube 601. The number of the pull-back wires 201 is the same as that of the limiting rods 102 of the bare stent system 1, the end points of the pull-back wires are connected with the barbs of the limiting rods 102, and the pull-back wires 201 can be disengaged from the barbs of the limiting rods 102 by controlling the pull-back directions.
Fig. 7 is a schematic view of a bare stent proximal control device of a bare stent dispenser. The guide head 301 is connected with a proximal fixing needle 401 of the bare stent, and the proximal fixing needle 401 of the bare stent is inserted into a corresponding hole of a proximal fixing cap 402 of the bare stent to hook the proximal end of the bare stent 101. The bare stent proximal limiting pin 404 penetrates through the tube wall of the bare stent proximal control rod 403 and extends into a part of the tube wall of the core tube 302. When the bare stent proximal end stopper pin 404 is pulled out, the bare stent proximal end control handle 405 is pulled down, and the bare stent proximal end fixing needle 401 is released to release the proximal end of the bare stent 101.
The number of the bare stent near-end fixing needles 401 is 4-6, the diameter is 0.5-1 mm, the bare stent near-end fixing cap 402 is provided with axial holes the same as the number of the bare stent near-end fixing needles 401, and the diameter of the axial holes is slightly larger than that of the bare stent near-end fixing needles 401. Fig. 8 is a schematic view of the remote control of a bare stent presenter. The distal end of the bare stent 101 is compressed between the bare stent proximal control rod 403 and the bare stent distal pressure tube 501, adjacent to the bare stent distal filling tube 502. The bare stent far-end limiting pin 503 penetrates through the tube wall of the bare stent far-end pressing tube 501 and the tube wall of the bare stent far-end filling tube 502 and extends into the tube wall of the bare stent near-end control rod 403. When the bare stent distal end limiting pin 503 is pulled out to the tube wall position of the bare stent distal end filling tube 502, the relative positions of the bare stent distal end filling tube 502 and the bare stent distal end pressing tube 501 are fixed, and the bare stent 101 can be driven to move forwards by pushing forwards. When the bare stent distal end limiting pin 503 is completely pulled out, the bare stent distal end pressing tube handle 504 is pulled down to drive the bare stent distal end pressing tube 501 to release the distal end of the bare stent 101.
The proximal end position of the bare stent distal end filling tube 502 is 5-10 mm shorter than the bare stent distal end pressing tube 501, and the thickness of the bare stent distal end filling tube is 0.5-1.5 mm.
The moving process of the restraint rod 102 drawn by the pullback wire 201 is shown in fig. 9, wherein fig. 9(a) is a schematic diagram of the pullback wire about to be released, fig. 9(b) is a schematic diagram of the pullback wire releasing, and fig. 9(c) is a schematic diagram of the pullback wire releasing completion.
During the use, at first pulling the sheath pipe makes naked support system 1 expose completely, operation naked support distal end controlling means 5 makes naked support 101 axial shorten, and pull back pull wire handle 203 is gone up with drawing naked support gag lever post 102 barb to move down simultaneously, until the gag lever post 102 barb catches on naked support 101 near-end, the length and the diameter of naked support 101 are fixed. At this time, the pull-back wire handle 203 is continuously pulled down to disengage from the barb of the stop lever 102, and the proximal end and the distal end of the bare stent 101 are respectively released.
The bare stent delivery device can realize the accurate positioning of the bare stent system 1, and can limit the length of the bare stent 101 according to the length of the limiting rod 102, so that the bare stent 101 is ensured to have enough radial supporting force, and the purpose of expanding a true cavity and extruding a false cavity is realized.
After the release of the bare stent system 1 is completed, the release of the occluding device 7 is performed. The occluder 7 is released through the diamond mesh and the far-end laceration of the interlayer of the bare stent 101 by a corresponding occluder dispenser in the order of the large disc 703, the short waist 704 and the small disc 701.
It should be appreciated that the main aortic dissection distal breach occlusion device of the present invention can be used with a bare stent system 1 in conjunction with multiple occluders 7 for the occlusion of multiple distal breaches.
Since most of the current intraluminal interventional procedures only block the proximal originating lacerations, no treatment is usually done for distal secondary lacerations. For most type B sandwich patients, if these secondary breaches are left untreated, blood flow continues to reflux into the false lumen, resulting in slow thrombosis and even a risk of rupture following continued dilatation. According to the aortic dissection distal laceration plugging device, the bare support is released through the releasing device, the axial length of the bare support can be fixed, the problem that the grid woven support cannot provide enough radial supporting force after being stretched after being pressed is solved, and the releasing position can be ensured to be more accurate. The setting of its plugging device also can be solved and risk such as damage to the pipe wall: on one hand, the design of the occluder with the arc-shaped large disc, the arc-shaped small disc and the short waist interface with different shapes can be perfectly matched with the shapes of the aortic lumen and the interlayer laceration, thereby reducing the risks of blood vessel damage and internal leakage; on one hand, the design of the small disc barb of the occluder can reduce the risk of falling off of the occluder; on the other hand, the relative position of the large disc and the short waist of the occluder is not fixed, so that the occluder can adapt to the pathological structure of a branch blood vessel near the laceration, and the physical damage of the large disc positioned in the false cavity to the inner wall of the false cavity is reduced.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims (9)

1. An aortic dissection distal laceration plugging device comprises a naked stent system (1) and a plugging device (7), and is characterized in that the naked stent system (1) comprises a naked stent (101) and a limiting rod (102);
the bare stent (101) is a net structure formed by metal wires;
the far end of the limiting rod (102) is flush with and fixedly connected with the far end of the bare stent (101), the near end of the limiting rod (102) is hooked on a metal wire at the near end of the bare stent (101) through a barb, the length of the bare stent (101) is limited through the fixed length of the limiting rod (102), and the bare stent (101) is ensured not to be axially elongated in a narrow true lumen of an aortic dissection so as to provide sufficient radial supporting force to expand the true lumen and reduce the false lumen;
the occluder (7) comprises a small disc (701), a hook (702), a large disc (703), a short waist (704) and a linear mark (705);
the center of the short waist (704) is concentrically arranged with the small disc (701), and the short waist (704) is concentrically arranged with the large disc (703) or eccentrically arranged;
the short waist (704) spans over the metal wire of the bare bracket (101), and two ends of the short waist are fixedly connected with the small disc (701) and the large disc (703) respectively, wherein the small disc (701) is positioned on the inner side of the bare bracket (101), and the large disc (703) is positioned on the outer side of the bare bracket (101);
the edges of the large disc (703) and the small disc (701) and the edges of the connecting surface of the large disc (703) and the short waist (704) are provided with the linear marks (705) made of X-ray opaque materials;
the small disc (701) is provided with a circle of hook (702) extending reversely from the disc center on one side of the short waist (704), the hook (702) is shaped like a semicircular arc and is tangent to the disc surface of the small disc (701), and the hook (702) hooks the metal wire of the bare support (101).
2. The aortic dissection distal laceration occlusion device of claim 1, wherein the wire diameter of the bare stent (101) is 0.2-0.6 mm; the limiting rod (102) is made of hard materials, and the length of the limiting rod is 20-100 mm.
3. The aortic dissection distal laceration plugging device of claim 1, wherein the occluder (7) is a net structure made of metal wires with wire diameter of 0.2-0.6 mm; the diameters of the large disc (703) and the small disc (701) are 10-25 mm, and the diameter of the large disc (703) is not smaller than that of the small disc (701); the length of the short waist (704) is 2-5 mm.
4. The distal aortic dissection closure device according to claim 1, wherein the short waist (704) has a circular, rhombic, triangular or trapezoidal cross section, the short waist (704) is connected with the large disc (703) and the small disc (701) in an arc transition manner, and the cross section of the contact between the short waist and the large disc (703) is sewn with a flexible blood-impermeable material.
5. The aortic dissection distal laceration plugging device of claim 1, wherein the plugging device further comprises a bare stent placer, the bare stent system (1) is conveyed and released by the bare stent placer, the bare stent placer comprises a pull-back wire control device (2), a core tube system (3), a bare stent proximal control device (4), a bare stent distal control device (5) and an outer sheath tube system (6), wherein the pull-back wire control device (2) comprises a pull-back wire (201), a pull-back wire double-layer tube (202) and a pull-back wire handle (203), the core tube system (3) comprises a guide head (301), a core tube (302) and a core tube handle (303), and the bare stent proximal control device (4) comprises a bare stent proximal fixing needle (401), a bare stent proximal fixing cap (402), a bare stent proximal control rod (403), The device comprises a bare stent proximal limiting pin (404) and a bare stent proximal control handle (405), the bare stent distal control device (5) comprises a bare stent distal pressing tube (501), a bare stent distal filling tube (502), a bare stent distal limiting pin (503), a bare stent distal pressing tube handle (504) and a bare stent distal filling tube handle (505), and the outer sheath tube system (6) comprises an outer sheath tube (601) and an outer sheath tube handle (602).
6. The aortic dissection distal laceration plugging device of claim 5, characterized in that the pull-back line (201) is located in the pull-back line double-layer tube (202) and connected with the pull-back line handle (203), the outer side of the pull-back line double-layer tube (202) is sleeved with an outer sheath tube (601), the end point of the pull-back line (201) is connected with the barb of the stop lever (102), and the pull-back line (201) and the barb of the stop lever (102) are controlled to be released.
7. The aortic dissection distal laceration occlusion device of claim 5, wherein the guiding head (301) is connected with the bare stent proximal fixing needle (401), and the bare stent proximal fixing needle (401) is inserted into the corresponding hole of the bare stent proximal fixing cap (402) to hook the proximal end of the bare stent (101); the bare bracket proximal end limiting pin (404) penetrates through the tube wall of the bare bracket proximal end control rod (403) and extends into part of the tube wall of the core tube (302); when the bare stent proximal end limiting pin (404) is pulled out, the bare stent proximal end control handle (405) is pulled down, and the bare stent proximal end fixing needle (401) is disengaged to release the proximal end of the bare stent (101).
8. The aortic dissection distal breach occlusion device of claim 5, wherein the bare stent (101) distal end is compressed between the bare stent proximal control rod (403) and the bare stent distal pressure tube (501), adjacent to the bare stent distal filling tube (502); the bare stent far-end limiting pin (503) penetrates through the tube wall of the bare stent far-end pressing tube (501) and the tube wall of the bare stent far-end filling tube (502) and extends into part of the tube wall of the bare stent near-end control rod (403); when the bare stent far-end limiting pin (503) is pulled out to the position of the tube wall of the bare stent far-end filling tube (502), the relative positions of the bare stent far-end filling tube (502) and the bare stent far-end pressing tube (501) are fixed, and the bare stent (101) is driven to move forwards by forward pushing; when the bare stent far-end limiting pin (503) is completely pulled out, the bare stent far-end pressing pipe handle (504) is pulled down to drive the bare stent far-end pressing pipe (501) so as to release the far end of the bare stent (101).
9. The aortic dissection distal breach occlusion device of claim 1, wherein the occlusion device is used by one bare stent system (1) in conjunction with multiple occluders (7) for occlusion of multiple distal breaches.
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