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WO2019144870A1 - Appareil d'obturation de déchirure de dissection aortique - Google Patents

Appareil d'obturation de déchirure de dissection aortique Download PDF

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Publication number
WO2019144870A1
WO2019144870A1 PCT/CN2019/072728 CN2019072728W WO2019144870A1 WO 2019144870 A1 WO2019144870 A1 WO 2019144870A1 CN 2019072728 W CN2019072728 W CN 2019072728W WO 2019144870 A1 WO2019144870 A1 WO 2019144870A1
Authority
WO
WIPO (PCT)
Prior art keywords
occlusion
aortic
occluding
clamping
blocking
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2019/072728
Other languages
English (en)
Chinese (zh)
Inventor
王永胜
吴俊飞
刘兴治
郭伟
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Wei Qiang Medical Technology Co Ltd
Original Assignee
Hangzhou Wei Qiang Medical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hangzhou Wei Qiang Medical Technology Co Ltd filed Critical Hangzhou Wei Qiang Medical Technology Co Ltd
Publication of WO2019144870A1 publication Critical patent/WO2019144870A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening

Definitions

  • the invention belongs to the technical field of medical instruments, and relates to a occlusion device, in particular to a occlusion device for aortic dissection treatment.
  • Aortic dissection aneurysm refers to one or more ruptures of the intima in the aortic lumen.
  • the blood in the lumen is separated by blood pressure to separate the inner and outer layers of the aorta, and active blood is formed between the walls.
  • the cavity and the pseudo-cavity expand and bulge to form an aortic dissection aneurysm.
  • the Stanford classification defines the dissection of the ascending aorta and aorta as a type A dissection aneurysm that will only define the type B dissection aneurysm with the dissection of the descending aorta.
  • the condition of type B dissection aneurysm is relatively stable.
  • the treatment plan can choose aortic endovascular repair, medical conservative treatment, surgical treatment, and aortic endovascular repair has become the preferred treatment for type B dissection.
  • endovascular repair of type B dissection aneurysms generally does not treat the distal end of the dissection; although the classic endovascular repair procedure is encouraging, the presence of the distal rupture and the blood flow in the false lumen are still Can lead to the occurrence of long-term aortic adverse events.
  • the distal end of the B-type dissection is mostly located around the visceral artery, if the traditional stent graft is used, it may lead to insufficient blood supply in the visceral area, which may endanger the patient's life safety; if open laparotomy + artificial blood vessel replacement is performed, It is traumatic and often difficult to be accepted by patients.
  • the condition of type B dissection aneurysm is relatively stable.
  • the treatment plan can choose aortic endovascular repair, medical conservative treatment, surgical treatment, and aortic endovascular repair has become the preferred treatment for type B dissection.
  • endovascular repair of type B dissection aneurysms generally does not treat the distal end of the dissection; although the classic endovascular repair procedure is encouraging, the presence of the distal rupture and the blood flow in the false lumen are still Can lead to the occurrence of long-term aortic adverse events.
  • the distal end of the B-type dissection is mostly located around the visceral artery, if the traditional stent graft is used, it may lead to insufficient blood supply in the visceral area, which may endanger the patient's life safety; if open laparotomy + artificial blood vessel replacement is performed, It is traumatic and often difficult to be accepted by patients.
  • the technical problem to be solved by the present invention is to provide an aortic dissection seal that is firmly fixed at the position of the break and designed according to the shape of the break, which can effectively prevent displacement and endoleak, in view of the defects of the prior art. Plugging device.
  • An aortic dissection occlusion device comprising a first occlusion portion, a second occlusion portion, and a tightening mechanism for tightening the first occlusion portion and the second occlusion portion;
  • the tightening mechanism includes a tightening member disposed on or between the first plugging portion and the second plugging portion, and a locking member for locking a tightening state of the tightening member .
  • the surfaces of the first blocking portion and the second blocking portion are respectively an inner disk surface, and the surfaces away from the inner disk surface are respectively outer a surface of the first occluding portion or/and the second occluding portion, wherein a fitting portion for abutting against a wall surface of the aorta is provided, the tightening mechanism tightening the first occlusion And the second occluding portion, the abutting portion abuts against the aortic wall surface and closes the aortic rupture.
  • the affixing portion is a proximal abutting portion provided at least around an edge of the aortic rupture
  • the abutting portion is a distal abutting portion that forms a gap ring with a gap between the aortic rupture;
  • the bonding portion is a bonding surface covering the aortic rupture.
  • the abutting portion is a flat block structure, or the abutting portion forms at least one flat annular structure.
  • the inner surface of the first blocking portion and the second blocking portion are each a planar structure or a curved surface structure.
  • the inner surface of the first occlusion portion and the second occlusion portion are each at least one of a flat surface, a tapered surface, and a curved surface. Or a combination thereof;
  • the inner disk surface of the first blocking portion and the second blocking portion is an irregular structure.
  • the abutting portion is the entire inner disk surface of the first occluding portion or/and the second occluding portion; or the fitting The portion of the inner wall surface of the first occlusion portion or/and the second occlusion portion is arched toward the aortic wall to form an annular structure or a planar structure.
  • the first occluding portion is provided with a first clamping portion; or/and the second occluding portion is provided with a second clamping portion;
  • the first clamping portion or/and the second clamping portion each cooperate with the opposing inner disk surface to clamp the aortic wall surface in a tightened state.
  • the first clamping portion is provided on an inner disk surface or/and an outer disk surface of the first blocking portion, or the first sealing portion The first clamping portion is disposed between the inner disk surface and the outer disk surface;
  • the second clamping portion is disposed on the inner disk surface or/and the outer disk surface of the second blocking portion, or the second portion is disposed between the inner disk surface and the outer disk surface of the second blocking portion Clamping portion
  • the first clamping portion or the second clamping portion each cooperates with the opposing inner disk surface to clamp the aortic wall surface in a tightened state.
  • the first clamping portion and the second clamping portion are respectively disposed at the same time, and the two are oppositely disposed to form a clamping of the aortic wall surface.
  • first clamping portion and the second clamping portion are respectively staggered, and each of them cooperates with the opposite inner disk surface to clamp the aortic wall surface.
  • the first clamping portion and the second clamping portion are at least one protrusion or arched toward or away from the direction of the aortic rupture. To form a clamping force.
  • the first clamping portion and the first occluding portion are integrally formed; the second clamping portion and the first portion
  • the second plugging portion is an integrally formed integral structure;
  • first clamping portion is fixedly connected or detachably connected to the first sealing portion;
  • second clamping portion is fixedly connected or detachably connected to the second sealing portion.
  • the first occlusion portion and/or the second occlusion portion are provided with at least one anchoring member, and the tightening mechanism tightens the first occlusion portion and The second occlusion portion drives the anchor to penetrate the wall of the aorta.
  • the first occluding portion and/or the second occluding portion are provided with at least one ring of anchors continuously or intermittently.
  • the first occlusion portion and the second occlusion portion are each a single-layer disc having only one layer or each of the plurality of seals A multi-layer disk formed by stacking the cells.
  • adjacent occlusion units in the multi-layer disc are at least partially adhered to each other without a gap, or adjacent seals in the multi-layer disc There is a gap between the blocking units that does not fit.
  • a waist portion is provided between the first occlusion portion and the second occlusion portion, and the first occlusion portion and the second portion
  • the occlusion portion is formed as an integrally formed integral structure, a fixed connection structure or a detachable fixed connection structure by a waist connection provided therebetween;
  • first occlusion portion and the second occlusion portion are independent split structures, and the two are detachable together by the tightening mechanism.
  • the tightening member and the locking member of the tightening mechanism are respectively connected to the first occlusion portion or the second occlusion portion, respectively
  • the irreversible locking or reversible locking between the tightening member and the locking member tightens the first occluding portion and the second occluding portion to seal the aortic rupture.
  • the reversible locking is: the tightening member and the locking member of the tightening mechanism are respectively associated with the first occluding portion or the first The two occlusion portions are connected, and the two splicing portions tighten the first occlusion portion and the second occlusion portion to seal the aortic artery.
  • the tightening member is disposed on the first occlusion portion or the waist lumen corresponding to the first occlusion portion, the locking The corresponding position is disposed on the second occlusion portion or only in the corresponding waist portion of the middle portion of the second occlusion portion, and the relative position of the tightening member and the locking member is satisfied: the two are screwed Thereafter, the first occlusion portion and the second occlusion portion are tightened to seal the aortic rupture.
  • the irreversible locking is: the tightening member is a wire or a rod fixedly disposed on the first occluding portion, the locking member In order to correspond to the hollow clamping sleeve disposed on the second sealing portion, the wire or the pull rod is clamped and locked in the clamping sleeve.
  • the reversible locking is: the tightening member is a wire or a rod fixedly disposed on the first occluding portion, the locking member Corresponding to the hollow axial sleeve disposed on the second plugging portion, the pull wire or the pull rod is provided with a locking joint, the pull wire or the rod diameter is smaller than the inner diameter of the sleeve, and the outer diameter of the locking joint is larger than the sleeve The inner diameter of the tube; the locking joint is pressed against the sleeve to press the cable or the tie rod at the end face of the sleeve.
  • the reversible locking is: the tightening member and the locking member of the tightening mechanism are respectively disposed at the first occlusion portion or the On the second occlusion portion, the first occlusion portion and the second occlusion portion are tightened to close the aortic rupture.
  • At least one layer of a blocking film for closing the aortic rupture is disposed on the first occlusion portion and/or the second occlusion portion;
  • At least one layer of the flow blocking film is disposed in the inner cavity of the first occlusion portion and/or the second occlusion portion.
  • the first occlusion portion and the second occlusion portion are respectively placed on both sides of the aortic rupture, and the tightening mechanism is placed in the first occlusion portion and the second occlusion portion, and the first occlusion portion and the first occlusion portion
  • the two blocking portions are tightened toward each other to reduce the spacing between the two, so that the first blocking portion and the second blocking portion are simultaneously clamped on both sides of the aortic wall surface to achieve a closed break.
  • the tightening mechanism is tightened, the clamping force of the first blocking portion and the second sealing portion to the breaking portion is increased, and the blocking device can be firmly fixed at the breaking point.
  • the sealing device according to the shape of the breaking according to the present invention is designed. The blocking device can effectively prevent the occurrence of displacement and endoleak.
  • FIG. 1A is a schematic structural view of a first embodiment of Embodiment 1 of the present invention.
  • FIG. 1B is a schematic structural view of a second embodiment of Embodiment 1 of the present invention.
  • Figure 2 is a partially enlarged plan view showing the distal end of the first occluding portion of the first embodiment of the present invention
  • Figure 3 is a partial enlarged view of the center of the proximal end of the second occlusion portion according to Embodiment 1 of the present invention.
  • Figure 4 is a cross-sectional view showing the apparatus of the first embodiment of the present invention after release
  • 5A-5E are schematic diagrams showing a process of using the device according to Embodiment 1 of the present invention.
  • Figure 6A is a structural diagram of Embodiment 2 of the present invention.
  • FIG. 6B is a schematic structural view of the tightening process of the device of FIG. 6A;
  • Figure 7 is a partial enlarged view of the distal end of the first occluding portion of Embodiment 2 of the present invention.
  • Figure 8 is a partial enlarged view of the center of the proximal end of the second occlusion portion according to Embodiment 2 of the present invention.
  • Figure 9A is a cross-sectional view of the device according to Embodiment 2 of the present invention after release;
  • Figure 9B is a partial enlarged view of M in Figure 9A;
  • Figure 10A is a schematic structural view of Embodiment 3 of the present invention.
  • Figure 10B is a cross-sectional view taken along line A-A of Figure 10A;
  • Figure 10C is a left side view of Figure 10A;
  • Figure 11 is an enlarged plan view showing the distal end of the first occluding portion of Embodiment 3 of the present invention.
  • Figure 12 is an enlarged view of the proximal end of the second occlusion portion according to Embodiment 3 of the present invention.
  • Figure 13 is a cross-sectional view showing the apparatus of the third embodiment of the present invention after release
  • Figure 14 is a structural diagram of Embodiment 4 of the present invention.
  • Figure 15 is an enlarged plan view showing the center of the first plugging portion of Embodiment 4 of the present invention.
  • Figure 16 is an enlarged plan view showing the vicinity of the center of the first plugging portion according to Embodiment 4 of the present invention.
  • Figure 17 is a central enlarged view of the second plugging portion of Embodiment 4 of the present invention.
  • Figure 18 is a cross-sectional view showing the apparatus of the fourth embodiment of the present invention after release
  • Figure 19 is a schematic view showing the structure of the tightening member of the tightening mechanism of the embodiment 4 of the present invention when entering the locking member;
  • Figure 20 is a schematic structural view of the tightening member of the tightening mechanism of the embodiment 4 of the present invention after entering the locking member;
  • Figure 21 is a schematic structural view of Embodiment 5 of the present invention.
  • Figure 22 is a first embodiment of the anchoring member according to Embodiment 6 of the present invention.
  • Figure 23 is a second embodiment of the embodiment of the present invention in which an anchor member is provided.
  • the distal end and the proximal end of the present invention are relative to the operator, the end of the occlusion device closer to the operator being the proximal end and the end remote from the operator being the distal end.
  • an aortic dissection occlusion device includes a first occlusion portion 110 and a second occlusion portion 120 and for the first occlusion portion 110 and the second occlusion portion 120.
  • a tightening mechanism 140 for clamping and closing the aortic rupture is tightened; the tightening mechanism 140 includes a tightening member 141 disposed on or between the first occluding portion 110 and the second occluding portion 120,
  • the locking member 142 that locks the tightening state of the tightening member 141, the first blocking portion 110 and the second blocking portion 120 are respectively located on both sides of the aortic breach.
  • the surfaces of the first blocking portion 110 and the second blocking portion 120 are respectively an inner disk surface 101 and a surface away from the inner disk surface 101 respectively.
  • the disk surface for attaching the aortic wall surface is the inner disk surface 101
  • the disk surface away from the aortic wall surface is the outer disk surface 102, respectively
  • the inner disk surface 101 of the second blocking portion 120 is provided with a bonding portion 103 that is in contact with the aortic wall surface.
  • the portion 103 compresses the aortic wall surface to close the aortic rupture, and the abutting portion 103 abuts against the aortic wall surface and closes the aortic rupture to further strengthen the clamping force.
  • the inner surface of the first blocking portion 110 and the second blocking portion 120 are opposite to the aortic wall surface, and are referred to as an inner disk surface 101, and the first blocking portion 110 and the second blocking portion 120 are referred to as an inner disk surface 101.
  • the upper disc surface away from the aortic wall surface is the outer disc surface 102, the inner disc surface 101 is adjacent to the aortic wall surface, and the outer disc surface 102 is away from the aortic wall surface.
  • the main function thereof is for pressing the aortic side wall on both sides of the rupture, and the first occluding portion 110 and the second occluding portion 120 are opposite.
  • At least one of the inner disc faces 101 has a structure that can close the aortic rupture. Therefore, in the present invention, the inner disc surface 101 of the first occluding portion 110 and the second occluding portion 120 need only have a surface attached to the aorta.
  • the bonding portion 103 that closes the aortic rupture is combined, and other shapes are not limited.
  • the inner disk surface 101 of the first blocking portion 110 and the second blocking portion 120 are each a planar structure or a curved surface structure, and the structures thereof may be the same or different.
  • the planar structure means that the inner disk surface 101 has a planar shape
  • the curved surface structure means that the inner disk surface 101 of the first blocking portion 110 and the second sealing portion 120 are each at least one of a tapered surface and a curved surface. Or a combination thereof; the planar structure and the curved surface structure are relatively regular disk-like structures.
  • the inner disk surface 101 of the first occluding portion 110 and the second occluding portion 120 may also have an irregular structure.
  • the irregular structure refers to an irregular structure in which the inner disk surface 101 of the first occluding portion 110 and the second occluding portion 120 can be formed in any shape or combination.
  • the plugging portion 103 is mainly used for sealing. According to the position of the bonding portion 103, there are the following embodiments:
  • the first embodiment of the fitting portion 103 is that the abutting portion 103 is a proximal fitting portion provided at least around the edge of the aortic rupture; this embodiment means that the closure starts from the aortic rupture, that is,
  • the conforming portion 103 extends outwardly from the aortic rupture, and the extension width is different according to different embodiments.
  • the inner disk surface 101 has a planar structure
  • the entire inner surface 101 is a bonding portion 103
  • the bonding portion 103 is a flat surface.
  • the bonding portion 103 is a part of the inner disk surface 101
  • the bonding portion 103 has at least one annular structure formed around the aortic rupture. If the plurality of annular structures are plural, the annular structures are preferably on the same plane. .
  • the bonding portion 103 is a distal bonding portion that forms a gap ring with a gap between the aortic ruptures.
  • the bonding portion 103 and the bonding portion 103 are There is a gap between the aortic ruptures to form a gap ring.
  • the inner disc surface 101 does not fit the aortic wall surface, and the fitting portion 103 may be a plane extending outward from the gap ring, or may be one or A plurality of annular structures surrounding the aorta.
  • the bonding unit 103 is a bonding surface that covers the aortic rupture.
  • the abutting portion 103 is the entire plane covering the aortic rupture
  • the affixing portion 103 is the entire inner disk surface 101 of the first occluding portion 110 or/and the second occluding portion 120.
  • the bonding portion 103 is the inner disk surface 101 of the first blocking portion 110, or the bonding portion 103 is the inner disk surface 101 of the second sealing portion 120.
  • the abutting portion 10 is a flat block structure, or the abutting portion 103 forms at least one flat annular structure so that the arching can form a uniform pressure or clamping force against the aortic rupture.
  • the flat block structure refers to arching to form a flat unitary structure to form a sufficient area to form an effective grip on the aortic wall surface.
  • Each of the first occluding portion 110 and the second occluding portion 120 is a single-layer disc having only one layer or a multi-layer disc each formed by a plurality of occluding units.
  • the adjacent plugging units in the multi-layer disc are at least partially adhered to each other without a gap
  • the partial fitting refers to the contact formed by the adjacent plugging unit through a partial surface, a line and a point, except for partial fitting. It is also possible to form all the fittings, that is, the adjacent blocking units are all bonded together without a gap, for example, as shown in FIG. 1A. In this way, the multi-layer disc can strengthen the overall strength and hardness and maintain its overall disc-like structure.
  • the gap between the adjacent plugging units in the multi-layer disc is not adhered. In this manner, except that the edges are connected or the edges are not connected, the adjacent plugging units are There is no contact at all. In this way, the remaining clearance can increase the axial compression space by increasing the tightening mechanism, and increase the corresponding closing clamping force, as shown in Fig. 1B.
  • the first occlusion portion 110 and the second occlusion portion 120 are configured in two cases. One is that a waist portion 130 is disposed between the first occlusion portion 110 and the second occlusion portion 120.
  • the blocking portion 110 and the second blocking portion 120 are connected by a waist portion 130 disposed therebetween to form an integral structure, and may be an integrally formed integral structure or a fixed connecting structure.
  • the waist portion 130 is a hollow columnar structure, and the inner disc surface 101 and the outer disc surface 102 of the first plugging portion 110 and the second plugging portion 120 extend toward each other to form a waist portion 130, so that the first plugging portion 110 and the second plugging portion 120 and
  • the waist portion 130 is an integrally formed integral structure; the waist portion 130 may also be a separate hollow columnar structure, and the first blocking portion 110 and the second sealing portion 120 are fixedly connected or detachably fixed by welding, bonding, fastening, and the like. Connected as a unitary fixed connection structure or detachable fixed connection structure. Another configuration is that the first occluding portion 110 and the second occluding portion 120 are separate and separate structures, and the two are detachable by the tightening mechanism 140.
  • first occluding portion 110 and the second occluding portion 120 are used for closing the aortic rupture, the first occluding portion 110 and the second occluding portion 120 are generally meshed in order to collect the entire device into the sheath.
  • Structure or frame structure The mesh structure or frame structure is formed by braided wire weaving or by cutting from a pipe or sheet.
  • the first occluding portion 110 and the second occluding portion 120 may be a flat disk mesh structure in which 18-288 wire diameters are the same or different wires are woven. As shown in FIG.
  • the centers of the first blocking portion 110 and the second blocking portion 120 are provided with the meeting points of the ends of the braided wires, and the ends of the braided wires pass through the confluent sleeve 112,
  • the 122 set is closed to prevent the end portion from sharply stabbing the aorta.
  • the first occlusion portion 110 meets the proximal end of the constriction portion 110 and is connected with the outer steel sleeve 112b and the inner steel sleeve 112a as the junction sleeve 112.
  • the meeting point 121 of the second plugging portion 120 faces the distal end and is connected with an outer steel sleeve 122b and an inner steel sleeve 122a as the junction sleeve 122.
  • the first blocking portion 110 and the second blocking portion 120 can be used to completely or completely block the aortic break. There is no need to add other auxiliary blocking components, but when the mesh is relatively large, at least one layer is required to be closed on the first occluding portion 110 and/or the second occluding portion 120 for closing the aortic rupture.
  • the flow blocking film 116 or the inner cavity of the first plugging portion 110 and/or the second plugging portion 120 is provided with at least one layer of the flow blocking film 116, and the blocking film is a sheet-like structure.
  • At least one layer of the flow blocking film 116 is attached to the outer wall surface of the first occluding portion 110 and/or the second occluding portion 120; or the first occluding portion 110 and/or the second sealing portion
  • At least one layer of the baffle film 116 is disposed in the inner cavity of the blocking portion 120, and the baffle film 116 disposed in the inner cavity may be directly attached to the inner wall surface or may be disposed in the middle portion of the inner cavity.
  • At least one blocking film 116 is disposed on the outer wall surface or the inner cavity of the blocking portion 110 and the second sealing portion 120. The blocking film 116 can occupy the entire disk laterally, and can also be in the first blocking portion 110 and the second sealing portion.
  • the main function of the baffle film 116 is to block the plug, so that a film-like structure made of a non-permeable material can be sewn to the first plugging portion 110 or/and the second plugging portion 120.
  • the material of the flow blocking film 116 may be selected from the group consisting of polyethylene terephthalate, expanded polytetrafluoroethylene material, polyurethane material or other high molecular polymer materials.
  • the tightening mechanism 140 In addition to the first occluding portion 110 and the second occluding portion 120, another important structure is the tightening mechanism 140.
  • the function of the tightening mechanism 140 is to axially close the first blocking portion 110 and the second blocking portion 120 after the first blocking portion 110 and the second blocking portion 120 are placed in position.
  • the first occluding portion 110 and the second occluding portion 120 are axially compressed on both sides of the aortic wall surface while being clamped to achieve a closed rupture.
  • the tightening member 141 and the locking member 142 of the tightening mechanism 140 are respectively connected to the first plugging portion 110 or the second plugging portion 120, that is, one of the tightening member 141 and the locking member 142 is connected to the first seal.
  • the blocking portion 110 is disposed in the inner cavity of the first occluding portion 110 corresponding to the waist portion 130, and the other portion is connected to the second occluding portion 120 or disposed in the inner cavity of the second clogging portion 120 corresponding to the waist portion 130. Since the first occlusion portion 110 serves as the distal end of the entire device during the operation, and is to enter the rupture cavity of the rupture, the tightening member 141 is generally fixed on the first occluding portion 110, and the second occluding portion 120 is used as At the proximal end of the device, the locking member 142 is secured to the second occluding portion 120.
  • the tightening member 141 and the locking member 142 of the tightening mechanism are respectively associated with the first occluding portion 110 or The second plugging portion 120 is connected.
  • the irreversible locking means that the tightening state cannot be released after locking. Both of them remain locked.
  • the reversible locking means that the locking can also be unlocked. After unlocking, the position of the first blocking portion 110 and the second sealing portion 120 can be adjusted or the blocking device can be removed, and then the locking device can be re-locked.
  • the first embodiment of the reversible locking is that the tightening member 141 and the locking member 142 of the tightening mechanism 140 are respectively disposed on the first blocking portion 110 or the second blocking portion 120, The first occluding portion 110 and the second occluding portion 120 are tightened to close the aortic rupture.
  • the tightening member 141 is fixedly disposed on the first occluding portion 110 or the corresponding waist cavity in the first occluding portion 110
  • the locking member 142 is disposed in the middle of the second occluding portion 120 correspondingly to the limit.
  • the distance between the tightening member 141 and the locking member 142 is only rotated, and the first blocking portion 110 and the second blocking portion 120 tighten the sealing aortic rupture. Reverse rotation after locking to unlock the screw.
  • the lock member 142 is rotated by the conveyor to receive the tightening member 141 by screwing, or the reverse rotation is used to release the screwing.
  • the second embodiment of the reversible locking is that the tightening member 141 is a wire fixedly disposed on the first occluding portion 110 or fixed in the inner cavity of the corresponding waist portion 130 on the first occluding portion 110.
  • the locking member 142 is a hollow axial sleeve 142a correspondingly disposed on the second sealing portion 120, and the pulling wire or the rod is provided with a locking portion 142b, the pulling wire or the rod diameter is smaller than the sleeve 142a
  • the inner diameter, the outer diameter of the locking portion 142b is larger than the inner diameter of the sleeve 142a; the locking portion 142b is deformed out of the sleeve 142a to press against the end face of the sleeve 142a to lock the wire or the tie rod.
  • the locking section 142b can be a nodule drawn on the pull wire or a nodule welded or bonded to the drawbar or pull wire.
  • the length of the locking segment 142b to the distal end of the tightening member 141 meets the requirements for closing the aortic breach.
  • the third embodiment of the reversible locking is preferably: the tightening member 141 and the locking member 142 of the tightening mechanism 140 are respectively disposed at the A blocking portion 110 or a second sealing portion 120 is engaged between the first blocking portion 110 and the second sealing portion 120 to close the aortic artery.
  • the irreversible locking is: the tightening member 141 is a pull wire or a pull rod fixedly disposed on the first plugging portion 110, and the locking member 142 is a hollow clip corresponding to the second blocking portion 120.
  • the tight sleeve, the pull wire or the pull rod is clamped and locked in the clamping sleeve.
  • the tightening member 141 and the locking member 142 of the tightening mechanism 140 are respectively disposed at the first blocking portion 110 or the second blocking portion.
  • the tightening mechanism 140 is generally disposed at the center of the first occluding portion 110 and the second occluding portion 120, it is easy to form a large center tightening force, and the outer tightening force is weaker, in some cases.
  • the first occluding portion 110 is provided with the first clamping portion;
  • Or/and the second occluding portion 120 is provided with a second clamping portion; the first clamping portion or/and the second clamping portion respectively cooperate with the opposing inner disk surface 101 to clamp the aorta in a tightened state Wall.
  • first clamping portion and the second clamping portion may be disposed at a position where the inner disk surface 101 of the first blocking portion 110 or/and the outer disk surface 102 is provided with a first clamping portion; or the first sealing portion
  • a first clamping portion is disposed between the inner disk surface 101 of the blocking portion 110 and the outer disk surface 102; or/and the inner disk surface 101 of the second blocking portion 120 or/and the outer disk surface 102 is provided with a second clamping portion, or
  • a second clamping portion is disposed between the inner disk surface 101 and the outer disk surface 102 of the second blocking portion 120; the first clamping portion and the second clamping portion are respectively matched with the opposite inner disk surface in a tightened state. Tightening the wall of the aorta. In this way, in addition to the relatively strong clamping in the center position, the other positions also form an effective clamping, which enhances the overall sealing effect of the blocking device.
  • first clamping portion is disposed on the first sealing portion 110, and the inner disk surface 101 of the corresponding second sealing portion 120 is flat or other for clamping. Holding the structure, that is, providing a first clamping portion on at least one of the inner disk surface 101 and the outer disk surface 102 of the first blocking portion 110 or between the two; or only setting the second blocking portion 120
  • the second clamping portion, the inner disk surface 101 of the corresponding first blocking portion 110 is a flat surface or other structure for clamping, at least one of the inner disk surface 101 and the outer disk surface 102 of the second blocking portion 120 or both A second clamping portion is provided between them.
  • the first clamping portion and the second clamping portion each cooperate with the opposing inner disk surface 101 to clamp the aortic wall surface in a tightened state.
  • first clamping portion and the second clamping portion are respectively disposed at the same time, that is, the first clamping portion and the second blocking portion 120 are respectively provided with the first clamping portion and the second portion.
  • the clamping portion that is, at least one of the inner disk surface 101 and the outer disk surface 102 of the first blocking portion 110 or both, is provided with a first clamping portion, and the inner disk surface 101 of the second sealing portion 120 A second clamping portion is provided on or between at least one of the outer disk faces 102.
  • the first clamping portion and the second clamping portion are respectively staggered, each of which cooperates with the opposite inner disk surface 101 to clamp the aortic wall surface, or the first clamping portion and the second clamping portion are oppositely disposed to form a pair of aorta Wall clamping.
  • the first clamping portion and the second clamping portion are at least one protrusion or arched toward the direction of the aortic tissue to form a clamping force
  • the protrusion or arching refers to the size of the protrusion if A single bulge is called a bulge, and if the bulge area is relatively large, it is called a bulge.
  • Direction toward the aortic tissue means that the first clamping portion and the second clamping portion protrude toward the aortic tissue relative to the inner disk surface 101, and the convex or arched portion presses the tissue surrounding the aortic fracture to achieve clamping.
  • first clamping portion and the second clamping portion are at least one protrusion or arched away from the direction of the aortic rupture to form a clamping force.
  • the direction of the aortic tissue back means that the first clamping portion and the second clamping portion are concave with respect to the inner disc surface 101 toward the aortic tissue, and the concave peripheral portion presses the tissue surrounding the aortic tear to achieve clamping.
  • the protrusion or the concave portion as the first clamping portion and the second clamping portion are both deformed by the tightening thereof, and the pressure on the tissue surrounding the aortic rupture is applied to form a clamping, which is stronger than the pressure.
  • the pressure of the plane on the tissue surrounding the artery is stronger than the pressure.
  • connection relationship between the first clamping portion and the first sealing portion 110, and the connection relationship between the second clamping portion and the second sealing portion 120 are various, and the first connection relationship is the first clamping
  • the first clamping portion and the second clamping portion 120 are respectively integrally formed integrally with the first sealing portion 110 and the second clamping portion 120, that is, the first clamping portion and the second clamping portion are respectively the first sealing portion.
  • a portion of the inner disk surface 101 or the outer disk surface 102 of 110 is formed by extending from the inner disk surface 101 or the outer disk surface 102, respectively.
  • the second embodiment is that the first clamping portion and the second clamping portion are fixedly connected to the first sealing portion 110 and the second sealing portion 120, that is, the first clamping portion is welded, bonded, or the like.
  • the second clamping portion is fixedly coupled to the first occluding portion 110 and the second occluding portion 120 or both.
  • the first clamping portion and the second clamping portion are detachably connected to the first blocking portion 110 and the second blocking portion 120, and the first clamping portion and the second clamping portion are integral.
  • the additional structure attached to the first occluding portion 110 and the second occluding portion 120 can be detachably connected to the first occluding portion 110 and the second occluding portion 120 by tying, screwing, or the like to form Multi-layer structure.
  • At least a portion of the inner disk surface 101 or/and the outer disk surface 102 of the first blocking portion 110 is a first clamping portion; or/and At least a portion of the inner disc surface 101 or/and the outer disc surface 102 of the second plugging portion 120 is a second clamping portion. That is, the first clamping portion and the second clamping portion may be part of the inner disk surface 101 or/and the outer disk surface 102, or the entire inner disk surface 101 or/and the outer disk surface 102 may be the first clamping portion or the first Two clamping parts.
  • the aortic dissection occlusion device is disposed on the outer circumference. At least one continuous or intermittent anchoring member, the tightening mechanism tightening the first occluding portion 110 and the second occluding portion 120 can drive the anchor into the aortic wall, as shown in FIG.
  • the anchoring member may be a barb or a protrusion, and the anchoring member provided by the engaging portion 103 of the inner disk surface 101 is advantageous for enhancing the combination of the first sealing portion 110 or/and the second sealing portion 120 with the aortic wall surface. Force to prevent continuous aspiration of the aortic blood flow to the first occluding portion 110 or/and the second occluding portion 120 to move the first occluding portion 110 or/and the second occluding portion 120, thereby affecting the aortic dissection Breaking the effect of blocking.
  • an aortic dissection occlusion device includes a first occlusion portion 110, a second occlusion portion 120, and a tightening mechanism 140.
  • the second blocking portion 120 and the first blocking portion 110 are parallel to each other and coaxial at the center.
  • the two blocking portions 120 may be of a unitary structure or a split structure.
  • the second blocking portion 120 and the first blocking portion 110 have an integral structure, and the middle portion is connected by the mesh structure waist portion 130.
  • the waist portion 130 is intermediate the second occluding portion 120 and the first occluding portion 110, and is coaxial with the centers of the two.
  • the first blocking portion 110, the second sealing portion 120 and the waist portion 130 are mesh structures formed by wire braiding or metal mesh tube cutting.
  • the mesh structure of the aortic dissection occlusion device may be one layer, or may be double-layered or multi-layered flat or have a certain curvature or other uneven structure.
  • the first occluding portion 110 and the second occluding portion 120 have a flat planar structure, that is, the first occluding portion 110 is a double-layered planar disk-shaped structure woven by a wire, and the structure is Invent the most basic structure. As shown in FIG.
  • the first occluding portion 110 and the second occluding portion 120 are uneven structures having a certain curvature, wherein the outer disk surface 102 and the inner disk surface 101 are arched away from the direction of the aortic rupture, forming a cone.
  • a first structure, the first clamping portion and the second clamping portion, the first clamping portion and the outer disk surface 102 of the first sealing portion 110 are integrally formed, the second clamping portion and the second sealing portion
  • the outer disk surface 102 of the portion 120 has an integral structure.
  • the two-layer structure of the first blocking portion 110 and the second blocking portion 120 is formed by 18-288 or other numbers of the same or different wire diameters to form a flat disk shape, and the wire has priority.
  • the nickel-titanium alloy wire is preferentially selected, and the wire diameter of the nickel-titanium alloy wire is 0.05-0.5 mm, and the first plugging portion 110 of the mesh structure can be shrunk to a smaller size by using the superelasticity of the nickel-titanium alloy. The diameter is transferred to the body through the conveyor and then expanded to its original shape.
  • the mesh structure of the second plugging portion 120 is the same as that of the first plugging portion 110, and details are not described herein again.
  • the waist portion 130 is an intermediate structure connecting the first plugging portion 110 and the second plugging portion 120, and the integral structure integrally formed with the first plugging portion 110 and the second plugging portion 120 is first
  • the central portion of the inner disk surface 101 of the occluding portion 110 and the second occluding portion 120 extends toward each other to form a waist portion 130.
  • the waist portion 130 may be disposed at any position between the first occluding portion 110 and the inner disk surface 101 of the second occluding portion 120, that is, according to the specific position and condition of the aortic rupture.
  • the middle portion of the inner disk surface 101 is disposed to the left, right, front or back, and the aortic dissection sealing device is set as an eccentric structure.
  • the first blocking portion 110 and the second blocking portion 120 may be in the form of a circle, an ellipse or the like to better accommodate the shape of the aortic rupture.
  • the inner disk surface 101 on the inner side opposite to the first plugging portion 110 and the second plugging portion 120 shown in FIG. 1A has a planar structure, and since it is a planar structure, the inner disk surface 101 as a whole is the bonding portion 103.
  • the flat portion 103 of the planar structure can be integrally bonded to the aorta, and the bonding area is large, and the sealing effect is good.
  • the inner disk surface 101 and the outer disk surface 102 of the first blocking portion 110 and the second blocking portion 120 shown in FIG. 1B are both arcuately shaped arches (larger-sized protrusions are called arches).
  • the first clamping portion and the second clamping portion are respectively formed, and the inner disk surface 101 is integrally formed with the peripheral outer edge of the outer disk surface 102.
  • the outer edge of the arch is contacted with the aorta prior to other portions. After the wall of the breach is clamped, the wall surface of the aortic fracture is clamped, and the tightening is continued.
  • the clamping force of the outer edge of the first sealing portion 110 and the second sealing portion 120 is increased, although it is away from the tightening mechanism 140, At the same time, the peripheral outer edge clamping and center clamping strength are ensured.
  • the braided wire forming the first occluding portion 110 is converged toward the proximal center and forms an annular meeting point 111 at the center, and the converged meeting point 111 is connected to the second occluding portion 120.
  • Confluence sleeve 112 confluence sleeve 112 includes outer steel sleeve 112b and inner steel sleeve 112a.
  • the positional relationship of the three is that the outer steel sleeve 112b is disposed outside the meeting point 111, the inner steel sleeve 112a is disposed inside the meeting point 111, and the braided wire at the meeting point 111 is sandwiched between the inner steel sleeve 112a and the outer steel sleeve 112b. Fixed, the three are welded together by welding. Preferably, the central axis of the meeting point 111 coincides with the central axis of the first occluding portion 110.
  • the braided wire forming the second occluding portion 120 is converged toward the distal center and forms an annular meeting point 121 at the center of the second occluding portion 120.
  • the meeting point 121 is converged and then turned to the first seal.
  • the blocking portion 110 is bent and connected to the converging sleeve 122.
  • the converging point 121 is located on the central axis of the second blocking portion 120 and the first blocking portion 110, and the confluent sleeve 122 of the second sealing portion 120 includes the outer steel sleeve 122b and the inner portion.
  • the steel sleeve 122a has a three-position relationship in which the outer steel sleeve 122b and the inner steel sleeve 122a sandwich the braided yarns of the joint points 121 arranged circumferentially from the inner and outer sides, and the three are coaxial.
  • the first plugging portion 110 is a multi-layer disc composed of two layers of plugging units, and the adjacent plugging units are all bonded together without a gap.
  • a baffle film 116 is sewn on the inner wall surface of the plugging unit between the two layers of plugging units.
  • a through hole 116a is formed at a position of the blocking film 116 corresponding to the tightening mechanism, and the tightening mechanism is worn in the through hole 116a.
  • the material of the flow blocking film 116 may be selected from the group consisting of polyethylene terephthalate, expanded polytetrafluoroethylene material, polyurethane material or other high molecular polymer materials.
  • the second blocking portion 120 selects the same structure as the first blocking portion 110, and details are not described herein again.
  • the first occlusion portion 110 and the second occlusion portion 120 are multi-layer discs composed of two layers of occlusion units, and gaps are left between adjacent occlusion units in the multi-layer discs.
  • the outer disc surface 102 is arched away from the direction of the aortic rupture to form a tapered structure.
  • a layer of baffle film 116 is sewn into the inner cavity between the two layers of plugging units.
  • a through hole 116a is formed in the position of the blocking film 116 corresponding to the tightening mechanism, and the tightening mechanism is tightened and passed through the through hole 116a.
  • the waist portion 130 is a hollow columnar structure
  • the tightening mechanism 140 is fixedly coupled to the first plugging portion 110 and the second plugging portion 120 and extends into the inner cavity of the waist portion 130.
  • the second occluding portion 120 and the first occluding portion 110 in this embodiment can be tightened by using the tightening mechanism 140.
  • the locking is reversible locking, that is, the locking is performed by using a threaded connection.
  • the tightening member 141 of the tightening mechanism 140 is connected to the first blocking portion 110 through the convergence sleeve 112, specifically, the tightening member 141.
  • the inner steel sleeve 112a is connected to the inner steel sleeve 112a or the two are integrated.
  • the tightening member 141 is a hollow tubular structure with internal threads.
  • the inner steel sleeve 112a and the tightening member 141 are integrally formed in the inner steel sleeve.
  • a stepped hole is provided, the distal end of which has a diameter smaller than the proximal end diameter, and the inner wall of the distal end of the stepped hole is provided with an internal thread 114, and the proximal inner wall is provided with an internal thread 115.
  • the locking member 142 in the tightening mechanism 140 is a screw
  • the screw is provided with an external thread 144
  • a square flange surface 142 is provided at the proximal end of the screw
  • a boss 143 is disposed in the middle of the screw.
  • the flange face 142 is integrated with the screw by welding.
  • the screw sleeve is disposed outside the converging sleeve 122 and is engaged by the flange surface 142 and the boss 143, and is not axially disengaged from the converging sleeve 122 of the second plugging portion 120, and is rotatable around the central axis of the confluent sleeve 122.
  • the distal end external thread 144 of the screw is threaded into the proximal internal thread 115 in the inner sleeve 112a of the first occluding portion 110.
  • the relative position of the tightening member 141 and the locking member 142 is satisfied: after the two are screwed together, the first blocking portion 110 and the second blocking portion 120 are tightened to block the aortic rupture.
  • the tightening mechanism 140 locks the first blocking portion 110 and the second blocking portion 120 by mechanical connection.
  • the first blocking portion 110 and the second blocking portion 120 may be disposed in the same or different configurations.
  • the tightening member 141 is a tubular or rod-like structure with external threads
  • the corresponding locking member 142 is a tubular structure with internal threads.
  • the device in clinical use, requires a catheter guidewire, a delivery sheath, a dilator, a loader, an inner cable, and an outer cable that can pass through the inner cable.
  • the method of use is as follows:
  • the external thread of the inner end of the inner cable is threaded through the loader and connected with the distal internal thread 114 on the inner steel sleeve 112a of the first clogging portion 110 in the occlusion device shown in FIG. 1B.
  • the cable passes through the loader along the inner cable and is mechanically coupled to the square flange face 142 at the proximal end of the screw as shown in FIG. Then the occlusion device is included in the loader;
  • Example 2 in the present embodiment is an improvement over Example 1 in the embodiment.
  • an aortic dissection occlusion device includes a first occlusion portion 110, a second occlusion portion 120, and a tightening mechanism 140.
  • the second blocking portion 120 and the first blocking portion 110 have an integral structure, and the middle portion is connected by the mesh structure waist portion 130.
  • the first plugging portion 110 is a double-layered conical disc-shaped structure woven by a wire, and a double-layer disc formed by laminating two blocking units.
  • the double-layer structure is woven by 36-144 nickel-titanium alloy wires to form a cone-shaped disc shape, and adjacent blocking units in the double-layer disc are bonded to each other without gaps.
  • the superelasticity of the nickel-titanium alloy can be used to shrink the mesh structure to a smaller diameter and transport it through the conveyor to expand into the original shape.
  • the inner disk surface 101 thereof is an inclined plane, a curved surface having a relatively large curvature, or an approximate plane, and the entire inner disk surface 101 is
  • the bonding unit 103 and the bonding unit 103 are integrated.
  • the outer disk surface 102 and the inner disk surface 101 are both arched away from the direction of the aortic rupture.
  • the tapered structure is a first clamping portion and a second clamping portion, and the first clamping portion and the first blocking portion respectively
  • the inner disk surface 101 and the outer disk surface 102 of the portion 110 are of an integral structure, and the second clamping portion is integrally formed with the inner disk surface 101 and the outer disk surface 102 of the second sealing portion 120, respectively.
  • the tightening mechanism 140 is tightened, and the centers of the first blocking portion 110 and the second blocking portion 120 tend to conform to the wall surface of the aorta. After the tightening is completed, the first blocking portion 110 and the second sealing portion The blocking portion 120 fits completely or substantially against the wall of the aorta.
  • the first sealing portion 110 meets the proximal point 111 and is connected to the outer steel sleeve as the junction sleeve 112.
  • the outer steel sleeve and the meeting point 111 are integrally welded by welding.
  • the mesh structure of the second plugging portion 120 in this embodiment is the same as the mesh structure of the first plugging portion 110.
  • the proximal end of the mesh structure of the second occluding portion 120 is converged at the meeting point 121 , and the meeting point 121 is located at the central axis of the second occluding portion 120 and the first occluding portion 110 .
  • the confluence point 121 is opposite to the distal end and is connected with a confluence sleeve 122.
  • the confluence sleeve 122 includes an outer steel sleeve 122b and an inner steel sleeve 122a. The three positional relationship is between the outer steel sleeve 122b and the inner steel sleeve 122a. Convergence point 121, and the three are coaxial.
  • the inner steel sleeve 122a has a clamping sleeve as a locking member 142 at the proximal end, and the clamping sleeve has an extension length of 1 to 2 mm.
  • the outer surface of the clamping sleeve is provided with an external thread 125 that connects the delivery device.
  • the first occluding portion 110 and the inner disk surface 101 of the second occluding portion 120 are each sewn with a baffle film 116.
  • the material of the permeable film 116 may be selected from polyterephthalic acid. Ethylene glycol ester, expanded polytetrafluoroethylene material, polyurethane material or other high molecular polymer materials.
  • the choke film may be disposed on the outer disc surface 102 of the first plugging portion 110 and the second plugging portion 120, or may be disposed between the two layers of plugging units, or may be disposed only on the inner disc surface 101.
  • a flow blocking film 116 is disposed in one of the first plugging portion 110 or the second plugging portion 120.
  • the second occluding portion 120 and the first occluding portion 110 are integrally formed integrally, and the two are connected by the mesh structure waist portion 130 to form a whole.
  • the waist portion 130 is formed by the first blocking portion 110 and the middle portion of the inner disk surface 101 of the second blocking portion 120.
  • the waist portion 130 is intermediate between the second blocking portion 120 and the first blocking portion 110, and is coaxial with the center thereof.
  • a barrier film 136 may also be sewn in the waist portion 130.
  • the material of the flow blocking film 136 may be selected from the group consisting of polyethylene terephthalate, expanded polytetrafluoroethylene material, polyurethane material or other high molecular polymer. material.
  • the second occluding portion 120 and the first occluding portion 110 in the embodiment can be tightened by using the tightening mechanism 140.
  • the waist portion 130 is a hollow columnar structure, and the tightening mechanism 140 is disposed in the waist portion 130.
  • the tightening mode is irreversible locking
  • the tightening member 141 is a wire or a pull rod fixedly disposed in the middle of the first plugging portion 110
  • the locking member 142 is correspondingly disposed on the second plugging portion 120.
  • the hollow clamping sleeve, the wire or the pull rod is inserted and clamped in the clamping sleeve.
  • the specific tightening member 141 of this embodiment is a pull wire of a polymer material for medical polymer material, such as a polypropylene suture or an expanded polytetrafluoroethylene wire.
  • the distal end of the wire is connected to the junction 111 of the first plugging portion 110.
  • the inner end of the inner steel sleeve 122a of the second plugging portion 120 is provided with a clamping sleeve as a locking member 142.
  • the pressing mechanism of the front end of the pusher is driven to push the clamping sleeve of the locking member 142 to be deformed. And tightening the tightening member 141 passing through the inner steel sleeve 122a.
  • the device In clinical use, the device needs to be connected to the catheter guide wire, the delivery sheath, the dilator, the loader, the inner steel cable, the transmission cable that can pass through the inner steel cable, and the outer steel cable that can transmit the steel cable.
  • the method of use is as follows:
  • the pusher is passed from the proximal end through the loader, and the proximal end of the tightening member 141 is passed through the pusher from the distal end by the lead wire, and the distal end of the pusher is connected with the junction of the second plugging portion 120.
  • the clogging device is included in the loader;
  • Release the occlusion device connect the front end of the loader to the rear end of the delivery sheath, and push the occlusion device to the rear end of the delivery sheath. Retracting the delivery sheath to release the first occluding portion 110 of the occlusion device in the false lumen; maintaining the relative position of the delivery device and slowly pulling the delivery sheath as a whole, so that the first occluding portion 110 abuts against the rupture of the interlayer Organizing; withdrawing the delivery sheath, so that the second occluding portion 120 of the occlusion device is released and deployed in the true cavity;
  • the conveying sheath is gently pushed forward to compress the second sealing portion 120 from a three-dimensional shape into a disk shape, and conformably abut against the fractured tissue of the interlayer to keep the conveying sheath stationary.
  • the tightening member 141 is pulled backward to compress the first blocking portion 110 from a three-dimensional shape into a disk shape, and conformably abut against the other surface of the sandwich breaking structure. Confirming the clamping effect, if no split or split is acceptable, driving the pressing mechanism at the front end of the pusher to deform and clamp the clamping sleeve of the inner steel sleeve 122a of the second plugging portion 120 through the tightening of the inner steel sleeve 122a Piece 141;
  • the conical central portion cannot conform to the aortic wall surface before locking, and the abutting portion 103 is associated with the aorta.
  • the inner disk surface 101 does not face the aortic wall.
  • the fitting portion 103 may be a plane extending outward from the gap ring. After the locking, the gap ring is reduced, and the fitting portion 103 is extended and extended to increase the clamping force on the tissue at the aortic rupture.
  • Example 3 the present embodiment is based on Example 1-2 Improvement.
  • the aortic dissection blocking device of the embodiment of the present invention includes a first occluding portion 110, a second occluding portion 120, and a waist portion 130.
  • the first plugging portion 110 and the second plugging portion 120 are double-layered discs with a wire braided structure, and are composed of two seals.
  • the double-layer disc formed by stacking the blocking units, and the adjacent blocking units in the double-layer disc are respectively adhered to each other without a gap.
  • the first plug portion 110 and the second plug portion 120 are both dense mesh structures woven from 72-144 nickel-titanium alloy wires. The superelasticity of the nickel-titanium alloy can be used to shrink the mesh structure to a smaller diameter and transport it through the conveyor to expand into the original shape.
  • the first plugging portion 110 can achieve a better sealing effect without the choke film.
  • the first occluding portion 110 and the second occluding portion 120 are arc-shaped surfaces that match the shape of the aortic wall, and the arcuate curvature is substantially the same as the aortic wall surface at the rupture, so that the two are clamped. After that, it can be completely attached to the wall of the aorta.
  • the bonding portion 103 is a bonding surface that covers the aortic rupture. In this embodiment, the abutting portion 103 is the entire plane of the entire first occluding portion 110, completely covering the aortic rupture.
  • the outer disk surface 102 and the inner disk surface 101 are both arched away from the direction of the aortic rupture.
  • the structure is a first clamping portion and a second clamping portion, and the first clamping portion and the first occluding portion 110 are inside.
  • the disk surface 101 and the outer disk surface 102 are integrally formed, and the second clamping portion is integrally formed with the inner disk surface 101 and the outer disk surface 102 of the second sealing portion 120.
  • the first sealing portion 110 meets the distal end 111 and is connected to the outer steel sleeve 112b as a junction sleeve.
  • the outer steel sleeve 112b and the meeting point 111 are integrally welded by welding.
  • the mesh structure of the second plugging portion 120 in this embodiment is the same as the mesh structure of the first plugging portion 110.
  • the proximal end of the mesh structure of the second occluding portion 120 is converged at the meeting point 121, the position of the meeting point 121 and the central axis of the second occluding portion 120 and the first occluding portion 110.
  • the confluence point 121 faces the proximal end and is connected with a confluence sleeve 122.
  • the confluence sleeve 122 includes an outer steel sleeve 122b and an inner steel sleeve 122a. The three positional relationship is between the outer steel sleeve 122b and the inner steel sleeve 122a. Convergence point 121, and the three are coaxial.
  • the outer surface of the outer steel sleeve 122b is provided with an external thread 125 that connects the delivery device.
  • the second blocking portion 120 and the first blocking portion 110 are of an integral structure, and the middle portion is connected by the mesh structure waist portion 130.
  • the waist portion 130 is intermediate between the second blocking portion 120 and the first blocking portion 110, and two The center is coaxial.
  • the second occluding portion 120 and the first occluding portion 110 in the embodiment can be tightened by using the tightening mechanism 140.
  • the first occluding portion 110 and the second sealing portion are used.
  • the locking member 141 is a cable or a pull rod fixedly disposed at a middle portion of the first blocking portion 110, and the locking member 142 is correspondingly disposed at the second blocking portion 120.
  • the pull wire or tie rod is provided with a locking joint 142b, the pull wire or tie rod diameter is smaller than the inner diameter of the sleeve 142a, and the outer diameter of the locking joint 142b is larger than the inner diameter of the sleeve 142a;
  • the segment 142b is deformed out of the sleeve 142a to press against the end of the sleeve 142a to lock the wire or tie rod.
  • the locking section 142b can be a nodule drawn on the pull wire or a nodule welded or bonded to the drawbar or pull wire.
  • the length of the locking segment 142b to the distal end of the tightening member 141 meets the requirements for closing the aortic breach.
  • the conveyor hooking sleeve 142a By the distal end of the conveyor hooking sleeve 142a, the conveyor is pulled such that the locking section 142b re-enters the sleeve 142a, unlocking.
  • the tightening member 141 is a polymer material medical wire material, such as a polypropylene suture or an expanded polytetrafluoroethylene wire, and the distal end thereof is connected to the first sealing portion 110 at a meeting point 111.
  • the tightening member 141 is a pull wire, and the locking member 142 is provided with a locking portion 142b provided on the pull wire and an inner steel sleeve 122a matched thereto, and the locking portion 142b is 3 to 5 mm away from the distal connection point.
  • the locking portion 142b is elastically deformed and pulled into the cavity of the inner steel sleeve 122a.
  • it passes through the cavity of the inner steel sleeve 122a, it is opened due to elastic deformation, thereby being fixed and The second plugging portion 120 and the first plugging portion 110 are tightened.
  • the device In clinical use, the device is intended for use with catheter guidewires, delivery sheaths, dilators, leadors, loaders, tightening catheters, and pushers.
  • the method of use is as follows:
  • the pusher is passed from the proximal end through the loader, and the proximal end of the tightening member 141 is passed through the pusher from the distal end by the lead wire, and the distal end of the pusher is connected with the junction of the second plugging portion 120,
  • the plugging device is included in the loader;
  • Release the occlusion device connect the front end of the loader to the rear end of the delivery sheath, and push the occlusion device to the rear end of the delivery sheath. Retracting the delivery sheath to release the first occluding portion 110 of the occlusion device in the false lumen; maintaining the relative position of the delivery device and slowly pulling the delivery sheath as a whole, so that the first occluding portion 110 abuts against the rupture of the interlayer Organizing; withdrawing the delivery sheath, so that the second occluding portion 120 of the occlusion device is released and deployed in the true cavity;
  • the conveying sheath is gently pushed forward to compress the second sealing portion 120 from a three-dimensional shape into a disk shape, and conformably abuts against the sandwiched tissue, keeping the conveying sheath stationary.
  • the tightening member 141 is pulled backward to compress the first blocking portion 110 from a three-dimensional shape into a disk shape, and conformably abut against the other surface of the sandwich breaking structure.
  • the proximal end of the tightening member 141 is pulled to elastically deform the locking portion 142b to be pulled into the cavity of the inner steel sleeve 122a, and the tightening member 141 is continuously pulled to pass the locking portion 142b through the cavity of the inner steel sleeve 122a, and is fixed and fixed. Tightening the second plugging portion 120 and the first plugging portion 110;
  • aortic dissection occlusion device comprising a first closure portion 110, the second blocking portion 120 and the tightening mechanism 140 of the present embodiment of the invention.
  • the first blocking portion 110 and the second blocking portion 120 are of a split structure.
  • the first plugging portion 110 is a double-layer or multi-layer three-dimensional structure woven by a wire, and the three-dimensional structure is a combination of a plane, a curved surface and a tapered surface, that is, the first seal.
  • the inner disk surface 101 of the blocking portion 110 is flat or nearly flat, and the outer disk surface 102 is tapered or curved, and the blocking unit disposed therebetween may be curved with different curvatures.
  • the three-dimensional structure can be compliantly attached to the inner surface of the dummy cavity.
  • the first plug portion 110 is woven from 72 nickel-titanium alloy wires.
  • the superelasticity of the nickel-titanium alloy can be used to shrink the mesh structure to a smaller diameter and transport it through the conveyor to expand into the original shape.
  • the gaps between the adjacent plugging units are not adhered. In this manner, except that the edges are connected or the edges are not connected, the adjacent plugging units are completely non-contact or partially in contact with each other. .
  • the outer disk surface 102 and the second sealing portion 120 of the first occluding portion 110 are arches facing away from the direction of the aortic rupture, and the structures are the first clamping portion and the second clamping portion, respectively.
  • the first clamping portion is integrally formed with the outer disk surface 102 of the first blocking portion 110, and the second clamping portion and the second sealing portion 120 are integrally formed.
  • the proximal outer surface 102 of the first occluding portion 110 is a centrally convex conical surface, and merges with the meeting point 111.
  • the meeting point 111 faces the distal end and is connected with the converging sleeve 112.
  • the outer steel sleeve 112b and the inner steel sleeve 112a are in a positional relationship in which the outer steel sleeve 112b includes a confluence 111, and the converging point 111 includes an inner steel sleeve 112a, and the three are integrally welded by welding. As shown in FIG.
  • the distal end surface of the first occluding portion 110 is a curved surface conforming to the outer wall of the false cavity and merges with the meeting point 131.
  • the meeting point 131 faces the proximal end and is connected with the outer steel sleeve 132.
  • the outer steel sleeve 132 includes a meeting point 131 and is integrally melted by welding.
  • the inner cavity of the first blocking portion 110 is respectively provided with two layers of the blocking film 116 attached to the outer end surface 102 and the inner inner surface 101 of the distal end, and the blocking film 116 is sewn on the first sealing portion 110.
  • the material of the flow blocking film 116 may be selected from the group consisting of polyethylene terephthalate, expanded polytetrafluoroethylene material, polyurethane material or other high molecular polymer materials.
  • the mesh structure of the second plugging portion 120 is different from the mesh structure of the first plugging portion 110.
  • the second blocking portion 120 is a single-layer tapered disk-shaped structure woven by a wire, and the second blocking portion 120 can also be a single-layer tapered cone-shaped disk structure formed by cutting a tube or a sheet.
  • the superelasticity of the nickel-titanium alloy can be used to shrink the mesh structure to a smaller diameter and transport it through the conveyor to expand into an original shape.
  • the proximal end of the mesh structure of the second occluding portion 120 is converged at the meeting point 121, and the meeting point position is located at the center of the second occluding portion 120, and the meeting point 121 is oriented toward the proximal end and connected
  • the outer steel sleeve 122b of the junction sleeve 122 and the inner steel sleeve 122a are in a positional relationship in which the outer steel sleeve 122b and the inner steel sleeve 122a are sandwiched by the circumferentially arranged converging points 121 from the inner and outer sides, and the three are coaxial.
  • the outer surface of the outer steel sleeve 122b is provided with an external thread 125.
  • the second blocking portion 120 has no obstruction film.
  • the outer disk surface 102 or the inner disk surface 101 of the second sealing portion 120 may also be covered with a blocking film 116.
  • the blocking film 116 The material may be selected from the group consisting of polyethylene terephthalate, expanded polytetrafluoroethylene materials, polyurethane materials or other high molecular polymer materials.
  • the first occluding portion 110 and the second occluding portion 120 are independent split structures, and the two are detachable by the tightening mechanism 140.
  • the method is reversible locking.
  • the tightening member 141 and the locking member 142 of the tightening mechanism 140 are respectively disposed on the first plugging portion 110 or the second plugging portion 120, and the first blocking portion 110 and the second sealing portion are respectively engaged between the two.
  • the blocking portion 120 tightens and seals the aortic rupture.
  • the tightening mechanism 140 adopts a snap connection, and two elastic cards welded to the proximal end of the steel sleeve 112a in the first sealing portion 110 are used as the tightening member 141, and the elastic card is formed by the proximal wedge-shaped latching position 141a and the distal end.
  • the elastic piece 141b is composed of.
  • the inner steel sleeve 122a of the second plugging portion 120 serves as a locking member 142.
  • the wedge-shaped latching position 141a when the wedge-shaped latching position 141a is pulled into the inner steel sleeve 122a of the second plugging portion 120, the elastic card is elastically deformed close to each other due to the pressing of the inner steel sleeve 122a, and the wedge shape is formed.
  • the card position 141a enters the inner hole of the inner steel sleeve 122a.
  • the wedge-shaped card position 141a completely passes through the inner steel sleeve 122a, the elastic sheet strain disappears due to the disappearance of the constraint, and the wedge-shaped card position 141a locks the inner steel sleeve 122a, thereby achieving the function of connecting and tightening.
  • the outer inclined surface of the wedge-shaped latching position 141a is pressed and contracted toward the center, and the wedge-shaped latching position 141a retreats into the inner hole of the inner steel sleeve 122a, and then retreats away from the inner steel sleeve 122a.
  • the inner hole is used to separate the two.
  • the device In clinical use, the device is intended for use with catheter guidewires, delivery sheaths, dilators, loaders, inner and outer cables.
  • the method of use is as follows:
  • the external thread of the inner end of the inner cable is threaded through the loader and connected with the internal thread 114 of the steel sleeve 112a in the first plugging portion 110; the outer cable is passed outside the inner cable through the loader and the second seal The junctions of the blocking portions 120 are connected, and then the second blocking portion 120 and the first blocking portion 110 are respectively collected into the loader in order;
  • Release the occlusion device connect the front end of the loader to the rear end of the delivery sheath and push the occlusion device to the distal end of the delivery sheath. Retracting the delivery sheath, releasing the first occluding portion 110 of the occlusion device in the sinus cavity; continuing to withdraw the delivery sheath, and releasing the second occluding portion 120 of the occlusion device in the true cavity;
  • Tightening Gently push the delivery sheath forward so that the second occluding portion 120 conforms to the dissection tissue to keep the delivery sheath intact.
  • the inner cable is pulled back so that the proximal wedge-shaped latch 141a of the elastic card is guided through the inner cable and passed through the inner steel sleeve 122a. Thereby, the second plugging portion 120 and the first plugging portion 110 are connected and tightened.
  • Embodiment 5 this embodiment is an improvement based on Embodiments 1-4.
  • the bonding portion 103 is only a part of the inner disk surface 101, and the bonding portion 103 is the first sealing portion 110 or/and the inner disk surface 101 of the second sealing portion 120.
  • the protrusion facing the aortic wall surface forms an annular structure or a planar structure, and the structure is also a first clamping portion facing the direction of the aortic rupture.
  • the affixing portion 103 of the present embodiment In order to form at least one annular structure around the aortic rupture, it is preferred that the annular structures are all in the same plane or substantially in the same plane.
  • the bonding portion 103 and the first clamping portion are one or more ring-shaped convex rings protruding from the inner disk surface 101 toward the aortic wall surface, and the plurality of ring-shaped convex rings are on the same plane or are pressed against the aortic wall surface to be in the same Plane or basically on a plane.
  • the first clamping portion presses the aortic wall surface prior to the other portions, and shortens the spacing between the first occluding portion 110 and the second occluding portion 120, and is particularly advantageous for the first occluding portion 110 and the second occluding portion
  • the outer edge of the portion 120 is tightened to avoid the problem of center tightening and outer edge relaxation.
  • the inner disk surfaces of the first occluding portion 110 and the second occluding portion 120 are irregular structures.
  • the inner disk surface 101 of the first blocking portion 110 and the second sealing portion 120 may have an irregular structure formed in any shape or combination.
  • Embodiment 6 this embodiment is an improvement based on Embodiment 1-5.
  • At least one anchor is provided on the first plugging portion 110 and the second plugging portion 120 in this embodiment.
  • the barb 150 is used as an anchoring member, and the barb 150 is disposed on the inner surface of the first sealing portion 110 or/and the second sealing portion 120, and the first blocking portion 110 or the second sealing portion.
  • the portion 120 is a unitary structure or a fixed connection mechanism.
  • the anchor member is continuously or intermittently disposed at least one turn on the outer circumference of the first occluding portion 110 or the second occluding portion 120, and the tightening mechanism 140 tightens the first occluding portion 110 and the second occluding portion 120 to drive
  • the anchoring member penetrates into the aortic wall surface.
  • the anchoring member may be a barb or a protrusion, and the anchoring portion of the fitting portion 103 provided on the inner disk surface 101 is advantageous for enhancing the first sealing.
  • the combined force of the portion 110 or/and the second occluding portion 120 with the aortic wall surface prevents the aortic blood flow from continuously scouring the first occluding portion 110 or/and the second occluding portion 120 such that the first occluding portion 110 Or / and the second occluding portion 120 moves, thereby affecting the sealing effect on the aortic dissection.
  • the barb 150 as an anchor may be disposed on the protrusion of the first clamping portion or the second clamping portion, or the fitting portion 103 may be disposed. on. Further strengthen the anchoring effect.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
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  • Gastroenterology & Hepatology (AREA)
  • Reproductive Health (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un appareil d'obturation de déchirure de dissection aortique, comprenant une première partie d'obturation (110), une seconde partie d'obturation (120), et un mécanisme de serrage (140) pour serrer la première partie d'obturation (110) et la seconde partie d'obturation (120). Le mécanisme de serrage (140) comprend un élément de serrage (141) disposé sur ou entre la première partie d'obturation (110) et la seconde partie d'obturation (120), et un élément de verrouillage (142) pour verrouiller l'élément de serrage (141). L'appareil d'obturation de la structure ci-dessus peut être fermement fixé à une position de déchirure, et un disque d'obturation est conçu selon la forme de déchirure, de telle sorte que l'occurrence d'un déplacement et d'une hémorragie interne peut être efficacement empêchée.
PCT/CN2019/072728 2018-01-25 2019-01-22 Appareil d'obturation de déchirure de dissection aortique Ceased WO2019144870A1 (fr)

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CN201810074083.7 2018-01-25

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US10888414B2 (en) 2019-03-20 2021-01-12 inQB8 Medical Technologies, LLC Aortic dissection implant
CN114533337A (zh) * 2022-02-25 2022-05-27 晨兴(南通)医疗器械有限公司 无铆心房分流器
CN115994883A (zh) * 2021-10-20 2023-04-21 上海微创卜算子医疗科技有限公司 主动脉夹层破口位置的检测方法、电子设备及存储介质
CN116273750A (zh) * 2023-03-30 2023-06-23 东风马勒热系统有限公司 一种蒸发器法兰浸涂密封装置
SE2351228A1 (en) * 2023-10-27 2025-04-28 Rafael Martin Astudillo Aortic dissection implant and aortic dissection system for remodelling and treating blood flow within a false lumen

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CN110074829B (zh) * 2018-01-25 2024-10-25 杭州唯强医疗科技有限公司 主动脉夹层破口封堵装置
CN110974316B (zh) * 2019-11-19 2021-06-04 先健科技(深圳)有限公司 封堵器
CN112807035B (zh) * 2021-02-01 2022-03-11 孟自力 一种用于瓣周漏的封堵器及接口调节装置
CN112773449B (zh) * 2021-02-08 2025-06-17 上海佐心医疗科技有限公司 医疗系统及医疗装置
CN113215723B (zh) * 2021-04-29 2025-10-17 珠海益心医疗科技有限公司 一种医疗器械的制造方法
CN113476100B (zh) * 2021-08-17 2022-09-30 郑州大学第一附属医院 一种主动脉夹层破裂口自扩张式封堵器
CN114010241B (zh) * 2021-11-16 2023-12-22 复旦大学附属中山医院 一种用于主动脉夹层破口修复的封堵装置
CN114767179B (zh) * 2022-04-09 2023-05-12 四川大学华西医院 一种房间隔缺损封堵器
CN116509468B (zh) * 2023-03-13 2023-10-27 杭州德诺电生理医疗科技有限公司 封堵系统及收紧件的打结方法
CN116138819B (zh) * 2023-04-04 2023-07-28 杭州唯强医疗科技有限公司 封堵装置和封堵系统
CN117426808B (zh) * 2023-12-21 2024-03-08 北京华脉泰科医疗器械股份有限公司 裙边结构、自适应裙边支架、封堵器和裙边制作方法
WO2025217959A1 (fr) * 2024-04-15 2025-10-23 邢泉生 Dispositif d'occlusion du foramen ovale du septum auriculaire dégradable formé d'un seul tenant en forme de disque double
CN119405380B (zh) * 2025-01-07 2025-04-11 上海形状记忆合金材料有限公司 一种用于主动脉夹层破口的封堵器

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Publication number Priority date Publication date Assignee Title
US10888414B2 (en) 2019-03-20 2021-01-12 inQB8 Medical Technologies, LLC Aortic dissection implant
CN115994883A (zh) * 2021-10-20 2023-04-21 上海微创卜算子医疗科技有限公司 主动脉夹层破口位置的检测方法、电子设备及存储介质
CN114533337A (zh) * 2022-02-25 2022-05-27 晨兴(南通)医疗器械有限公司 无铆心房分流器
CN116273750A (zh) * 2023-03-30 2023-06-23 东风马勒热系统有限公司 一种蒸发器法兰浸涂密封装置
CN116273750B (zh) * 2023-03-30 2025-07-25 东风马勒热系统有限公司 一种蒸发器法兰浸涂密封装置
SE2351228A1 (en) * 2023-10-27 2025-04-28 Rafael Martin Astudillo Aortic dissection implant and aortic dissection system for remodelling and treating blood flow within a false lumen

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