WO2021128938A1 - 一种封堵器及系统 - Google Patents

一种封堵器及系统 Download PDF

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Publication number
WO2021128938A1
WO2021128938A1 PCT/CN2020/113613 CN2020113613W WO2021128938A1 WO 2021128938 A1 WO2021128938 A1 WO 2021128938A1 CN 2020113613 W CN2020113613 W CN 2020113613W WO 2021128938 A1 WO2021128938 A1 WO 2021128938A1
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WO
WIPO (PCT)
Prior art keywords
wire
occlusion device
occluder
anchoring mechanism
predetermined shape
Prior art date
Application number
PCT/CN2020/113613
Other languages
English (en)
French (fr)
Inventor
屠春霖
陆清声
张广建
张兆夺
袁振宇
朱清
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海微创心脉医疗科技(集团)股份有限公司 filed Critical 上海微创心脉医疗科技(集团)股份有限公司
Priority to US17/787,025 priority Critical patent/US20230008857A1/en
Priority to JP2022539283A priority patent/JP2023508441A/ja
Priority to KR1020227025379A priority patent/KR20220119460A/ko
Priority to EP20908043.1A priority patent/EP4082451A4/en
Priority to BR112022012545A priority patent/BR112022012545A2/pt
Publication of WO2021128938A1 publication Critical patent/WO2021128938A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12154—Coils or wires having stretch limiting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B2017/00579—Barbed implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device

Definitions

  • the present invention relates to the technical field of medical devices, in particular to an occluder and system.
  • AD Aortic dissection
  • EVAR endovascular aortic repair
  • the principle of EVAR is to deliver an implant into the aorta, and use the implant to seal the primary breach in the aortic lumen, so that the blood flow in the false lumen is slowed down or even disappeared to form thrombosis and gradually become organized. Absorb to restore the shape of the true cavity, that is, the blood supply of the visceral artery, and finally achieve the purpose of aortic remodeling. Compared with other treatments (such as open surgery), EVAR has the advantages of less trauma, lower perioperative mortality, and faster recovery.
  • the main treatment methods for distal ruptures are: (1) adding implants to seal the distal rupture; (2) aortic replacement; (3) conservative treatment and close observation.
  • the treatment (1) may lead to insufficient blood supply to the visceral area and endanger the life of the patient, the treatment (2) has the risk of high postoperative mortality and paraplegia, and the treatment (3) will cause the distal end of the postoperative patient
  • the poor expansion of the true lumen of the artery and the continuous perfusion of the false lumen seriously affect the benign remodeling of the distal aorta and the patient’s late prognosis.
  • occluders are widely used to seal the distal rupture.
  • Occlusion device therapy belongs to the "targeted therapy" in the field of endovascular therapy. It strives to isolate the breach without affecting the blood supply of adjacent important branch arteries. The probability of important branch arteries ischemia and organ infarction is low after surgery, so The occluder has many advantages in AD treatment, which makes it have broad clinical application value.
  • the occluder used to seal the breach in the prior art has many problems.
  • the shape of the occluder is loose after release, the occlusion effect is not good, and the occluder has no fixing device in the blood vessel for fixing, resulting in occlusion.
  • the device is displaced under the impact of blood flow and cannot achieve the purpose of plugging.
  • the purpose of the present invention is to provide an occluder and a system, which can maintain a predetermined shape after being released to ensure the occlusion effect, promote the thrombosis of the false cavity, and realize the remodeling of the true cavity.
  • the present invention provides an occlusion device, including a body, the body includes a sizing wire and a spring coil, the sizing wire is a resilient metal wire and is configured to have a predetermined shape, the The spring coil is sleeved on the sizing wire, so that the body is formed into the predetermined shape.
  • the occluder further includes an anchoring mechanism connected to one end of the shaping wire, and the anchoring mechanism can rotate around the axis of the shaping wire, the anchoring mechanism It is used to fix the body on the target.
  • the sizing wire is coiled into a continuous curved structure to form the predetermined shape.
  • the predetermined shape is a spiral shape
  • the sizing wire is spirally wound along an axis to form the spiral shape.
  • the predetermined shape is a conical shape
  • the sizing wire is wound into a plurality of arc-shaped segments connected in sequence, and in the axial direction of the conical shape, the plurality of arc-shaped segments are arranged in sequence and adjacent to each other.
  • the two arc-shaped segments are eccentrically arranged.
  • the body in the axial direction of the cone, has a first end and a second end opposite to each other.
  • the radial direction of the cone is The cross section gradually increases, the radial size of each arc segment gradually increases, and the anchoring mechanism is arranged on the second end.
  • the predetermined shape is spherical or hexahedral.
  • the anchoring mechanism includes a positioning portion, the positioning portion is a barb or a fixed disk, and the positioning portion is used to connect with the target.
  • a tip structure is provided on the positioning portion, and the tip structure is used to pierce the inner wall of the blood vessel to fix the body.
  • the occlusion device further includes thrombus-promoting villi, and the thrombus-promoting villi are attached to the body.
  • the bolt-promoting fluff is wound on the sizing wire and clamped and fixed by the spring coil.
  • At least two of the tether-promoting fluffs are arranged on the styling wire at intervals, and in the axial direction of the styling thread, the distance between two adjacent tether-promoting fluffs is 5mm-10mm.
  • the length of the thrombus-promoting villi is 15mm-25mm.
  • the inner diameter of the spring coil is 0.5 mm-1.0 mm.
  • the present invention also provides an occlusion system, which includes a stent and at least one occlusion device as described above, and the occlusion device is connected to the stent.
  • the occluder and system of the present invention have the following advantages:
  • the occluder includes a body, wherein the body includes a sizing wire and a spring coil, the sizing wire is a resilient metal wire and is configured to have a predetermined shape, and the spring coil is sleeved on the The sizing wire is used to form the body into the predetermined shape. The shape of the body is maintained by the sizing wire, so that the occluder can effectively seal the breach.
  • the occluder also includes an anchoring mechanism, the anchoring mechanism is made of resilient metal, the anchoring mechanism is arranged on the body, and is used to fix the body to the target Material.
  • An anchoring mechanism is used to fix the position of the body, so as to avoid displacement of the body.
  • the anchoring mechanism is connected to one end of the shaping wire, and the anchoring mechanism can rotate around the axis of the shaping wire to offset the occluder during the process of being sent into the aorta and released The torsion effect produced by the spring coil.
  • Figure 1 is a cross-sectional view of a blood vessel in a region where aortic dissection occurs in a patient;
  • Figure 2 is a schematic diagram of the structure of the occluder provided by the first embodiment of the present invention, and the ball head is not shown in the figure;
  • Fig. 3 is a schematic diagram of the occlusion system provided by the first embodiment of the present invention being implanted in the aorta and occluding the breach, and only one occluder is shown in the figure;
  • Figure 4 is a schematic structural view of the sizing wire of the occluder provided by the first embodiment of the present invention.
  • Figure 5 is a schematic structural diagram of the spring coil of the occlusion device provided by the first embodiment of the present invention, and the spring coil is not sleeved on the shaping wire in the figure;
  • Figure 6 is a schematic view of the structure of the body of the occlusion device according to the first embodiment of the present invention.
  • Figure 7 is a schematic structural diagram of the occluder provided by the first embodiment of the present invention.
  • the occluder is stretched into a linear structure, and the anchoring mechanism is not shown in the figure;
  • Figure 8a is a schematic structural view of the anchoring mechanism of the occluder provided by the first embodiment of the present invention.
  • Figure 8b is a schematic diagram of a deformed structure of the anchoring mechanism of the occluder shown in Figure 8a;
  • Fig. 8c is a schematic diagram of another deformed structure of the anchoring mechanism of the occluder shown in Fig. 8a;
  • Figure 8d is a schematic diagram of another deformed structure of the anchoring mechanism of the occluder shown in Figure 8a;
  • Figure 9 is a schematic diagram of the connection relationship between the anchoring mechanism and the shaping wire of the occluder according to the first embodiment of the present invention.
  • FIG. 10 is a schematic diagram of the connection relationship between the anchoring mechanism of the occluder and the stent according to the first embodiment of the present invention
  • Fig. 11a is a schematic diagram of the connection relationship between the occlusion device and the introduction system according to the first embodiment of the present invention
  • Fig. 11b is a schematic diagram of another connection relationship between the occlusion device and the introduction system according to the first embodiment of the present invention.
  • Figure 12 is a schematic structural view of the occluder provided by the second embodiment of the present invention.
  • Fig. 13 is a schematic diagram of the occlusion system provided by the second embodiment of the present invention being implanted in the aorta and occluding the breach, and only one occluder is shown in the figure;
  • Figure 14 is a schematic structural view of the occluder provided by the third embodiment of the present invention.
  • FIG. 15 is a schematic diagram of the occlusion system provided by the third embodiment of the present invention being implanted in the aorta and occluding the breach, and only one occluder is shown in the figure;
  • Figure 16a is a schematic structural view in one direction of the occlusion device provided by the fourth embodiment of the present invention.
  • Fig. 16b is a schematic structural view of the occlusion device shown in Fig. 16a in another direction;
  • Fig. 16c is a schematic structural view of the occlusion device shown in Fig. 16a in another direction;
  • FIG. 17 is a schematic diagram of the occlusion system provided by the fourth embodiment of the present invention being implanted in the aorta and occluding the breach, and only one occluder is shown in the figure;
  • Figure 18 is a schematic view of the structure of the occlusion device provided by the fifth embodiment of the present invention.
  • Fig. 19 is a schematic diagram of the occlusion system provided by the fifth embodiment of the present invention being implanted in the aorta and occluding the rupture, and only one occluder is shown in the figure.
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “plurality” includes two or more objects, unless the content clearly indicates otherwise.
  • the term “or” is usually used to include the meaning of “and/or”, unless the content clearly indicates otherwise, and the terms “installed”, “connected”, and “connected” shall be used. In a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected, or indirectly connected through an intermediate medium, and it can be a communication between two elements or an interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above-mentioned terms in the present invention can be understood according to specific situations. In the drawings, the same or similar reference signs represent the same or similar components.
  • proximal and distal refer to the relative position, relative position, and direction of elements or actions relative to each other from the perspective of the doctor using the medical device, although the “proximal” and “distal” “Is not restrictive, but “proximal” usually refers to the end that is close to the doctor during normal operation, and “distal” usually refers to the end that first enters the patient's body.
  • Figure 1 shows a cross-sectional view of a blood vessel in a region where aortic dissection occurs in a patient.
  • the aortic intima tears causing the media to separate to form a true lumen 10 and a false lumen 20 in the blood vessel, and the true lumen 10 and the false lumen 20 Connect through the breach 30.
  • the purpose of the embodiments of the present invention is to provide an occluder, which can be used to occlude the false cavity 20 and occlude the breach 30 in the treatment of aortic dissection, so as to block the blood flow from entering the place.
  • the false cavity 20 promotes thrombosis of the false cavity 20.
  • FIG. 2 is a schematic diagram of the structure of the occlusion device 100 provided by the first embodiment of the present invention.
  • the occluder 100 includes a body 110 that includes a sizing wire 111 and a spring coil 112.
  • the sizing wire 111 is a resilient metal wire and is configured to have a predetermined shape;
  • the spring ring 112 is sleeved on the shaping wire 111.
  • the body 110 When treating the aortic dissection, the body 110 is filled in the false cavity 20 and the breach 30 is sealed.
  • a resilient metal wire as the sizing wire 111, and the sizing wire 111 is configured into a predetermined shape
  • the spring coil 112 is sleeved on the sizing wire 111 to form the body 110
  • the main body 110 also exhibits the predetermined shape.
  • the shape of the body 110 In the process of delivering the occluder 100 to the blood vessel, the shape of the body 110 is changed, and when the occluder 100 is released in the blood vessel, under the action of the resilience of the shaping wire 111 ,
  • the body 110 returns to the predetermined shape. That is to say, in the embodiment of the present invention, the shape of the body 110 is maintained by the sizing wire 111 so as to effectively block the breach 30.
  • the occluder 100 further includes an anchoring mechanism 120, the anchoring mechanism 120 is made of a resilient metal, and the anchoring mechanism 120 is disposed on the body 110, and the anchoring mechanism 120 is One end of the shaping wire is connected, and the anchoring mechanism can rotate around the axis of the shaping wire, and the anchoring mechanism is used to fix the body 110 to the target.
  • the occluder 100 can be used together with a stent 200 to treat aortic dissection. As shown in FIG. 3, when the occluder 100 and the stent 200 are used together to treat aortic dissection, the stent 200 is used for positioning in the true cavity 10 and supporting the true cavity 10 , In order to reduce the compression of the false cavity 20 on the true cavity 10.
  • the occluder 100 is implanted in the false cavity 20 and positioned at the breach 30 to reduce or even block the blood flow into the false cavity 20 and promote the thrombosis of the false cavity 20.
  • the occluder 100 includes an anchoring mechanism 120, and the occluder 100 and the stent 200 are connected by the anchoring mechanism 120.
  • the bracket 200 has a hollow structure 210, and the anchoring mechanism 120 can be inserted into the hollow structure 210 to be connected to the bracket 200 (the bracket 200 is the target), so that the The occluder 100 is held at the breach 30 to realize the positioning of the main body 110 and prevent the main body 110 from deviating from the breach 30 due to the impact of blood flow, thereby affecting the treatment effect.
  • the shaping wire 111 can be made of shape memory alloy (for example, nickel-titanium alloy, copper-nickel alloy, copper-zinc alloy, etc.), cobalt-chromium alloy, stainless steel, or the like.
  • shape memory alloy for example, nickel-titanium alloy, copper-nickel alloy, copper-zinc alloy, etc.
  • cobalt-chromium alloy stainless steel, or the like.
  • the sizing wire 111 is coiled to assume the predetermined shape, and the sizing wire 111 is heat-treated so that the sizing wire 111 has the predetermined shape in a natural state.
  • the shape of the sizing wire 111 can be changed, but when the external force is cancelled, the sizing wire 111 can be restored to the predetermined shape.
  • the styling wire 111 is coiled into a continuous and smooth curved structure, so that when the body 110 is finally formed, the body 110 has no sharp bends, so as to avoid scratching the blood vessel when it is implanted. Damage.
  • the spring ring 112 is formed by forming a spring structure by surrounding a metal wire along a mandrel, and then heating and shaping the two ends of the metal wire.
  • the spring ring 112 can be made of nickel-titanium wire, platinum tungsten wire, stainless steel wire, or the like. According to actual needs, the outer diameter of the mandrel is 0.5 mm-1.0 mm, so that the inner diameter of the spring ring 112 is 0.5-1.0 mm.
  • the sizing wire 111 is straighten the sizing wire 111 of a predetermined shape, and then the spring coil 112 is sleeved on the sizing wire 111. After the force is cancelled, the sizing wire 111 returns to the predetermined shape under the action of its own resilience force, thereby obtaining the body 110 of the predetermined shape (ie, as shown in FIG. 6).
  • the two ends of the spring coil 112 are respectively connected to the two ends of the shaping wire 111 to prevent the spring coil 112 from untwisting during the release process of the occluder 100.
  • the predetermined shape is a spiral shape.
  • the sizing wire 111 is spirally wound around an axis to form a conical spiral structure.
  • the body 110 has opposite first and second ends, and from the first end to the second end, the radial cross-section of the body 110 gradually Increase.
  • the anchoring mechanism 120 is disposed on the second end of the main body 110, and a ball head is disposed on the first end of the main body 110 (not shown in FIGS. 2 and 4).
  • the styling wire can also be spirally wound around an axis to form a cylindrical spiral structure (not shown).
  • the anchoring mechanism 120 may be made of a shape memory alloy (for example, a nickel-titanium alloy, a copper-nickel alloy, a copper-zinc alloy, etc.), a cobalt-chromium alloy, or stainless steel. As shown in Figures 8a-8d, the anchoring mechanism 120 has a positioning portion 121. In some embodiments, as shown in Figures 8a, 8b, and 8c, the positioning portion 121 is a barb, and in another In some embodiments, the positioning portion 121 may be a fixed disk, and the fixed disk may be formed by sequentially arranging a plurality of rods bent into a V shape around an axis (as shown in FIG. 8d). Of course, the anchoring mechanism 120 may also have other structures, as long as it can be connected to the bracket 200, which is not limited in this embodiment.
  • a shape memory alloy for example, a nickel-titanium alloy, a copper-nickel alloy, a copper-zinc alloy, etc.
  • the positioning portion 121 is also provided with a tip structure 122.
  • the occluder 100 cannot be positioned on the breach 30.
  • the tip structure 122 is used to pierce the inner wall of the blood vessel to keep the occluder 100 at the breach 30.
  • the anchoring mechanism 120 When the occluder 100 is implanted into a blood vessel, the anchoring mechanism 120 bears a relatively large force. In order to prevent the anchoring mechanism 120 from transmitting the force to the spring coil 112 and causing the spring coil 112 is detached from the shaping wire 111, the anchoring mechanism 120 is preferably connected to the shaping wire 111, and the anchoring mechanism 120 can rotate around the axis of the shaping wire 111.
  • the anchoring mechanism 120 further includes a sleeve 123, the positioning portion 121 is fixedly disposed on the sleeve 123, and the sleeve 123 has a first inner cavity.
  • One end of the sizing wire 111 is inserted into the first cavity of the sleeve 123, and a first limiting portion 124 is provided in the first cavity, and the end of the sizing wire 111 is provided with a second limiting portion.
  • the second limit part cooperates with the first limit part 124 to keep the sizing wire 111 and the sleeve 123 relatively stationary in the axial direction, but In the circumferential direction, the sizing wire 111 and the sleeve 123 are relatively rotatable.
  • the advantage of this arrangement is that, referring to FIGS. 3 and 10, after the occluder 100 is delivered into the blood vessel, the anchoring mechanism 120 needs to be inserted into the hollow structure 210 to realize the anchoring mechanism 120 and The connection of the bracket 200. When the occluder 100 is delivered, the styling wire 111 is straightened.
  • the styling wire 111 After the occluder 100 is released in the blood vessel, the styling wire 111 returns to the predetermined shape under the action of its own resilience. During the process, the sizing wire 111 is twisted, and the sleeve 123 can rotate relative to the sizing wire 111 to offset the adverse effect of the twisting of the sizing wire 111 on the posture adjustment of the anchoring mechanism 120.
  • the anchoring mechanism 120 can smoothly enter the hollow structure 210 of the bracket 200.
  • the occlusion device 100 further includes thrombus-promoting villi 130 attached to the body 110 to increase the filling of the occluder 100 Area, promote the thrombosis of the false cavity 20.
  • the material of the thrombus-promoting fluff 130 can be polyethylene terephthalate (PET), polyamide (PA), polyethylene (PE), polypropylene (PP), polyurethane (PU) or At least one of polymer materials such as polylactic acid (PLA). These polymer materials are made into 300-700D fully stretched yarns or stretched textured yarns and then wound two to three turns on the shaping yarn 111, and are clamped and positioned by the adjacent two turns of the spring coil 112.
  • the thrombus-promoting villi 130 can be formed (that is, as shown in FIG. 7). Further, on the main body 110, the plug-promoting fluffs 130 are arranged at intervals along the axial direction of the sizing wire 111, and the axial distance between two adjacent plug-promoting fluffs 130 is 5mm-10mm. In addition, the length of each of the tether-promoting villi 130 (the length of the tether-promoting villi 130 from the connection point on the styling wire 111 to the free end of the tether-promoting villi 130) is 15mm-25mm.
  • the occluder 100 is implanted into the blood vessel through the introducing device 300.
  • the introduction device 300 has a second lumen for accommodating the occluder 100, and the second lumen extends along the axial direction of the introduction device 300 and has opposite proximal and distal ends, wherein the distal A release mechanism 310 is provided at the end.
  • the occluder 100 is implanted in a blood vessel, the occluder 100 is straightened and placed in the second lumen.
  • the first end of the occluder 100 The upper ball head 113 is connected to the release mechanism 310, and the occluder 100 is transported from the true cavity 10 to the false cavity 20 at this time.
  • the introduction system 300 releases the occluder 100 and releases the connection between the release mechanism 310 and the ball head 113.
  • the anchoring mechanism 120 of the occluder 100 is connected to the release mechanism 310. In this manner, the occluder 100 is removed from the false cavity. 20 is transported to the breach 30.
  • Figure 12 shows a schematic diagram of the structure of the occluder 100 provided by the second embodiment of the present invention.
  • the following description only introduces the differences between this embodiment and the first embodiment, and other structures may be the same as the first embodiment. Settings, so I won’t repeat them here.
  • the sizing wire 111 is wound into the outer contour of a spherical structure (here, the spherical structure includes a spherical structure in a geometric sense, and also includes a substantially spherical structure), so that the body 110 has a spherical structure.
  • One end of the shaping wire 111 extends to the outside of the spherical structure to facilitate the connection of the anchoring mechanism 120.
  • the occluder 100 provided in this embodiment can also be used together with the stent 200 to treat aortic dissection.
  • FIG. 14 shows a schematic structural diagram of an occluder 100 provided by the third embodiment of the present invention.
  • the sizing wire 111 in this embodiment is wound into an outer contour of a regular hexahedron structure.
  • the occluder 100 provided in this embodiment can be used with the stent 200 to treat aortic dissection.
  • Figures 16a to 16c show schematic views of the structure of the occluder 100 provided by the fourth embodiment of the present invention.
  • the body 110 of the occluder 100 in this embodiment is in a conical shape as a whole.
  • the shaping wire is bent to form a In the axial direction, a plurality of arc-shaped segments are sequentially arranged, and two adjacent arc-shaped segments are eccentrically arranged.
  • the advantage of this arrangement is that there is no large gap on the body 110, so that the occluder 100 can better seal the breach 30.
  • each arc segment gradually increases, so that the arc segment with a smaller radial size is closer to the blood vessel wall.
  • each of the arc-shaped segments is approximately circular, and the smaller the radial size of the arc-shaped segment, the more difficult it is for the spring ring 112 of this segment to kink when the occluder 100 is released, which is beneficial to improve The performance of the occluder 100.
  • the occluder 100 provided by this embodiment can be used together with the stent 200 for the treatment of aortic dissection.
  • Fig. 18 shows a schematic structural diagram of an occlusion device 100 provided by a fifth embodiment of the present invention.
  • the occluder 100 has a spherical structure.
  • the difference from the second embodiment is that a part of the sizing wire 111 is wound into the outer contour of the spherical structure, and the other of the sizing wire 111 A part is coiled in the internal cavity of the spherical structure.
  • One end of the styling wire 111 extends to the outside of the spherical structure to facilitate connection with the anchoring mechanism 120.
  • the sizing wire 111 is coiled to form a plurality of arc-shaped segments, and the plurality of arc-shaped segments constitute the spherical structure. Further, preferably, each of the arc-shaped segments is approximately circular. In this embodiment, the sizing wire 111 is coiled into a spherical structure, and the sizing wire 111 is also coiled inside the spherical structure.
  • the spring coil 112 is sleeved on the sizing wire 111 to form the body 110, The body 110 does not have a large gap, so as to help block blood flow.
  • the occluder 100 provided by this embodiment and the stent 200 can be used together for the treatment of aortic dissection.
  • the occlusion system includes an occluder 100 and a stent 200, the stent 200 is positioned in the true cavity 10 and has a hollow structure 210, the sealing The occluder 100 is implanted in the false cavity 20 and positioned at the breach 30, and the anchoring mechanism 120 on the occluder 100 is inserted into the hollow structure 210 to be connected to the stent 200.
  • the occlusion system includes at least one occluder 100.
  • the length of the stent 200 is better to cover all the breaches 30, and the number of the occluder 100 can be as large as The number of the breaches 30 is equal, so that each breach 30 is provided with an occluder 100 to block the blood flow into the false cavity 20 and promote the thrombosis of the false cavity 20.
  • the occluder 100 and system provided by the embodiments of the present invention, wherein the occluder 100 includes a body 110 and an anchoring mechanism 120, the body 110 includes a sizing wire 111 and a spring coil 112, and the sizing wire 111 has a return
  • the elastic metal wire is configured to have a predetermined shape
  • the spring coil 112 is sleeved on the shaping wire 111 so that the body 110 is formed into a predetermined shape
  • the anchoring mechanism 120 is provided on the body 110 , And used to connect with the target (bracket 200).
  • the body 110 can maintain a predetermined shape after being released to ensure the sealing of the breach 30.
  • the anchoring mechanism 120 is used to connect the occluder 100 is positioned at the breach 30 to avoid the displacement of the occluder 100 caused by the impact of blood flow, which may affect the blocking effect.

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Abstract

一种封堵器（100）及系统，封堵器（100）包括本体（110），本体（110）包括定型丝（111）和弹簧圈（112），定型丝（111）为具有回弹性的金属丝，并被配置为具有预定形状，弹簧圈（112）套设在定型丝（111）上，以使本体（110）形成预定形状。通过定型丝（111）约束本体（110）的形状，使得本体（110）在主动脉夹层的治疗中可有效封堵破口（30）。

Description

一种封堵器及系统 技术领域
本发明涉及医疗器械技术领域，具体涉及一种封堵器及系统。
背景技术
主动脉夹层(aortic dissection，AD)，是指主动脉腔内的血液从主动脉内膜撕裂处进入主动脉中膜，使中膜分离，沿主动脉长轴方向扩展形成主动脉壁的真假两腔分离的状态。AD是一种心血管急危病症，起病急、进展快，死亡率极高。目前，主动脉腔内修复术(endovascular aortic repair，EVAR)是临床上针对AD最广泛采用的治疗手段。EVAR的原理是向主动脉中送入植入物，利用所述植入物在主动脉腔内封堵原发破口，使假腔内血流减慢甚至消失而形成血栓化，并逐渐机化吸收，以恢复真腔形态即内脏动脉供血，最终达到主动脉重塑的目的。与其他治疗手段(例如开放性外科手术)相比，EVAR具有创伤小、围术期死亡率低、康复快等优点。
从理论上来看，在主动脉真腔中封堵原发破口后，由原发破口进入假腔的血流消失，假腔内的压力骤然降低，其对真腔的压迫也随之减轻，随着时间的延长，假腔逐渐血栓化并机化吸收，真腔形态即可恢复。但实际治疗中，有些AD患者在进行EVAR后主动脉并不能完成理想的重塑，其主要原因在于EVAR仅封堵近心端的原发破口，而大部分的AD患者往往并发多处破口，且破口大多位于内脏动脉周围(即破口多为远端破口)。目前，对于远端破口的处理方式主要有：(1)增加植入物以封闭远端破口；(2)主动脉置换；(3)保守治疗，严密观察。第(1)种处理可能导致内脏区供血不足、危及患者生命，第(2)种处理存在术后死亡率和截瘫率高的风险，而第(3)种处理则会导致术后远端主动脉真腔扩张不佳，假腔存在持续灌注，严重影响远端主动脉良性重塑和患者晚期预后。
对于AD，较为理想的手术方式是修复主动脉全程破口，促进假腔血栓化，现有技术中广泛采用封堵器封堵远端破口。封堵器治疗属于腔内治疗领域的“靶向治疗”，力求将破口隔绝而不影响临近重要分支动脉的血供，术后发生重要分支动脉缺血、脏器梗死的概率较低，因而封堵器在AD治疗方面具有 诸多优势，使其具有广阔的临床应用价值。然而，现有技术中用于封堵破口的封堵器存在诸多问题，例如封堵器释放后形态松散，封堵效果不佳，且封堵器在血管中没有固定装置进行固定导致封堵器在血流冲击下出现移位现象而无法实现封堵目的。
发明内容
本发明的目的在于提供一种封堵器及系统，该封堵器在释放后可保持预定形态，以确保封堵效果，促进假腔血栓化，实现真腔的重塑。
为实现上述目的，本发明提供的一种封堵器，包括本体，所述本体包括定型丝和弹簧圈，所述定型丝为具有回弹性的金属丝，并被配置为具有预定形状，所述弹簧圈套设在所述定型丝上，以使所述本体形成所述预定形状。
可选地，所述封堵器还包括锚定机构，所述锚定机构与所述定型丝的一端连接，且所述锚定机构可绕所述定型丝的轴线旋转，所述锚定机构用于将所述本体固定于目标物上。
可选地，所述定型丝盘绕成连续的曲线结构以形成所述预定形状。
可选地，所述预定形状为螺旋形，所述定型丝沿一轴线螺旋缠绕以形成所述螺旋形。
可选地，所述预定形状为圆锥形，所述定型丝盘绕成多个依次连接的弧形段，在所述圆锥形的轴线方向上，多个所述弧形段依次布置，且相邻两个所述弧形段偏心设置。
可选地，在所述圆锥形的轴线方向上，所述本体具有相对的第一端和第二端，沿着所述第一端到所述第二端的方向，所述圆锥形的径向截面逐渐增大，每个所述弧形段的径向尺寸逐渐增大，所述锚定机构设置在所述第二端上。
可选地，所述预定形状为球形或六面体形。
可选地，所述锚定机构包括定位部，所述定位部为倒钩或固定盘，所述定位部用于与所述目标物连接。
可选地，所述定位部上设有尖端结构，所述尖端结构用于刺入血管内壁以固定所述本体。
可选地，所述封堵器还包括促栓绒毛，所述促栓绒毛附着于所述本体上。
可选地，所述促栓绒毛缠绕在所述定型丝上，并被所述弹簧圈夹持固定。
可选地，至少两个所述促栓绒毛间隔地设置在所述定型丝上，在所述定型丝的轴线方向上，相邻两个所述促栓绒毛之间的距离为5mm-10mm。
可选地，所述促栓绒毛的长度为15mm-25mm。
可选地，所述弹簧圈的内径为0.5mm-1.0mm。
为实现上述目的，本发明还提供了一种封堵系统，包括支架和至少一个如上所述的封堵器，所述封堵器与所述支架连接。
与现有技术相比，本发明的封堵器及系统具有如下优点：
第一、所述封堵器包括本体，其中所述本体包括定型丝和弹簧圈，所述定型丝为具有回弹性的金属丝，并被配置为具有预定形状，所述弹簧圈套设在所述定型丝上，以使所述本体形成所述预定形状。通过定型丝来保持所述本体的形状，使得封堵器可有效封堵破口。
第二、所述封堵器还包括锚定机构，所述锚定机构由具有回弹性的金属制作而成，所述锚定机构设置于所述本体上，并用于将所述本体固定于目标物上。利用锚定机构来固定所述本体的位置，以达到避免本体移位的目的。
第三、所述锚定机构与所述定型丝的一端连接，且所述锚定机构可绕所述定型丝的轴线旋转，以抵消所述封堵器在送入主动脉并释放的过程中所述弹簧圈所产生的扭转效应。
附图说明
图1是患者体内发生主动脉夹层区域的血管的剖视图；
图2是本发明根据第一实施例所提供的封堵器的结构示意图，图中未示出球头；
图3是本发明根据第一实施例所提供的封堵系统植入主动脉并封堵破口的示意图，图中仅示出一个封堵器；
图4是本发明根据第一实施例所提供的封堵器之定型丝的结构示意图；
图5是本发明根据第一实施例所提供的封堵器之弹簧圈的结构示意图，图示中弹簧圈未套设在定型丝上；
图6是本发明根据第一实施例所提供的封堵器之本体的结构示意图；
图7是本发明根据第一实施例所提供的封堵器的结构示意图，图示中封堵器被拉伸为直线型结构，且图中未示出锚定机构；
图8a是本发明根据第一实施例所提供的封堵器之锚定机构的结构示意图；
图8b是图8a所示封堵器之锚定机构的一个变形结构示意图；
图8c是图8a所示封堵器之锚定机构的另一个变形结构示意图；
图8d是图8a所示封堵器之锚定机构的又一个变形结构示意图；
图9是本发明根据第一实施例所提供的封堵器之锚定机构与定型丝之间的连接关系示意图；
图10是本发明根据第一实施例所提供的封堵器之锚定机构与支架的连接关系示意图；
图11a是本发明根据第一实施例所提供的封堵器与导入系统的连接关系示意图；
图11b是本发明根据第一实施例所提供的封堵器与导入系统的另一种连接关系示意图；
图12是本发明根据第二实施例所提供的封堵器的结构示意图；
图13是本发明根据第二实施例所提供的封堵系统植入主动脉并封堵破口的示意图，图中仅示出一个封堵器；
图14是本发明根据第三实施例所提供的封堵器的结构示意图；
图15是本发明根据第三实施例所提供的封堵系统植入主动脉并封堵破口的示意图，图中仅示出一个封堵器；
图16a是本发明根据第四实施例所提供的封堵器在一个方向上的结构示意图；
图16b是图16a所示的封堵器在另一个方向上的结构示意图；
图16c是图16a所示的封堵器在再一个方向上的结构示意图；
图17是本发明根据第四实施例所提供的封堵系统植入主动脉并封堵破口的示意图，图中仅示出一个封堵器；
图18是本发明根据第五实施例所提供的封堵器的结构示意图；
图19是本发明根据第五实施例所提供的封堵系统植入主动脉并封堵破口的示意图，图中仅示出一个封堵器。
[附图标记说明如下]：
100-封堵器；
110-本体；
111-定型丝，112-弹簧圈，113-球头；
120-锚定机构；
121-定位部，122-尖端结构，123-套管，124-第一限位部；
130-促栓绒毛；
200-支架；
210-镂空结构；
300-导入装置；
310-解脱机构；
10-真腔，20-假腔，30-破口。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。附图中，相同或相似的附图标记代表相同或相似的部件。
本文中，术语“近端”、“远端”是从使用该医疗器械的医生的角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”、“远端”并非是限制性的，但“近端”通常是指在正常操作过程中靠近医生的一端，而“远端”通常是指首先进入患者体内的一端。
图1示出了患者体内发生主动脉夹层区域的血管的剖视图。如图1所示，当患者发生主动脉夹层时，主动脉内膜撕裂，使得中膜分离而在血管中形成真腔10和假腔20，且所述真腔10和所述假腔20通过破口30连通。本发明实施例的目的在于提供一种封堵器，所述封堵器可在主动脉夹层的治疗中用于填塞所述假腔20并封堵所述破口30，以阻隔血流进入所述假腔20，促进所述假腔20血栓化。
图2是本发明第一实施例所提供的封堵器100的结构示意图。如图2所示，所述封堵器100包括本体110，所述本体110包括定型丝111和弹簧圈112，所述定型丝111为具有回弹性的金属丝，并被配置为具有预定形状；所述弹簧圈112套设在所述定型丝111上。
在治疗所述主动脉夹层时，所述本体110填充于所述假腔20内并封堵所述破口30。通过采用具有回弹性的金属丝作为所述定型丝111，并且所述定型丝111被配置为预定形状，当所述弹簧圈112套设在所述定型丝111上以形成所述本体110时，所述本体110亦呈现为所述预定形状。将所述封堵器100输送至血管的过程中，所述本体110的形态被改变，而当所述封堵器100在血管中被释放后，在所述定型丝111的回弹力的作用下，所述本体110恢复至所述预定形状。也就是说，本发明实施例通过定型丝111保持所述本体110的形状，以使其有效封堵所述破口30。
进一步地，所述封堵器100还包括锚定机构120，所述锚定机构120由具有回弹性的金属制作而成，且所述锚定机构120设置于所述本体110上，与所述定型丝的一端连接，且所述锚定机构可绕所述定型丝的轴线旋转，所述锚定机构用于将所述本体110固定于目标物上。
请重点参考图3，所述封堵器100可与一支架200共同使用，以用于治疗主动脉夹层。如图3所示，当所述封堵器100和支架200共同使用以治疗主 动脉夹层时，所述支架200用于定位在所述真腔10内并对所述真腔10起到支撑作用，以减小所述假腔20对所述真腔10的压迫。所述封堵器100植入所述假腔20内，并定位在所述破口30处，以减小甚至阻断进入所述假腔20的血流，促进所述假腔20血栓化。所述封堵器100包括锚定机构120，所述封堵器100与所述支架200通过所述锚定机构120连接。具体的，所述支架200上具有镂空结构210，所述锚定机构120可插入所述镂空结构210而与所述支架200连接(所述支架200即为所述目标物)，以使所述封堵器100保持在所述破口30处，以实现所述本体110定位，避免所述本体110因血流冲击而偏离所述破口30，进而影响治疗效果。
下面介绍本实施例中所述封堵器100的具体结构及制作过程。
所述定型丝111可采用形状记忆合金(例如镍钛合金、铜镍合金、铜锌合金等)、钴铬合金或不锈钢等制作而成。所述定型丝111经盘绕而呈所述预定形状，并通过对所述定型丝111进行热处理，以使所述定型丝111在自然状态下具有所述预定形状。当所述定型丝111受到外力作用时，所述定型丝111的形状可被改变，但当所述外力取消时，所述定型丝111能够恢复至所述预定形状。
优选地，所述定型丝111盘绕成连续且光滑的曲线结构，从而在最终形成所述本体110时，所述本体110没有尖锐的折角，以避免在植入血管时对血管造成剐蹭而出现二次伤害。
如图5所示，所述弹簧圈112由金属丝沿一芯轴环绕成弹簧结构，然后对所述金属丝的两端加热定型而成。所述弹簧圈112可采用镍钛丝、铂钨丝、不锈钢丝等制作。根据实际需要，所述芯轴的外径为0.5mm-1.0mm，以使所述弹簧圈112的内径为0.5-1.0mm。
然后，向所述定型丝111施加作用力，以将预定形状的所述定型丝111抻直，再将所述弹簧圈112套设在所述定型丝111上。取消所述作用力后，所述定型丝111在其自身回弹力的作用下恢复至所述预定形状，从而得到预定形状的所述本体110(即如图6所示)。优选地，所述弹簧圈112的两端分别与所述定型丝111的两端连接，以防止在所述封堵器100的释放过程中出现 所述弹簧圈112解旋的现象。
进一步地，本实施例中，所述预定形状是螺旋形。例如，请参考图2并结合图4，所述定型丝111围绕一轴线螺旋盘绕而形成圆锥状的螺旋形结构。如此一来，沿所述轴线的延伸方向，所述本体110具有相对的第一端和第二端，且从所述第一端到所述第二端，所述本体110的径向截面逐渐增大。所述锚定机构120设置于所述本体110之第二端上，而在所述本体110之第一端上设置有球头(图2及图4中未示出)。在另一种实现方式中，所述定型丝还可以围绕一轴线螺旋盘绕而形成圆柱状的螺旋形结构(未图示)。
所述锚定机构120可由形状记忆合金(例如镍钛合金、铜镍合金、铜锌合金等)、钴铬合金或不锈钢等制作而成。如图8a-图8d所示，所述锚定机构120具有定位部121，在一些实施例中，如图8a、图8b及图8c所示，所述定位部121是倒钩，而在另一些实施例中，所述定位部121可以是固定盘，所述固定盘可由多根弯折成V形的杆体绕一轴线依次布置而构成(如图8d所示)。当然所述锚定机构120还可以是其他结构，只要其能够实现与所述支架200的连接即可，对此本实施不做限定。
进一步地，如图8c所示，所述定位部121上还设有尖端结构122，当所述定位部121与所述支架200连接也不能将所述封堵器100定位于所述破口30处时，所述尖端结构122用于刺入血管内壁，以使所述封堵器100保持在所述破口30处。
将所述封堵器100植入血管时，所述锚定机构120承受了较大的作用力，为避免所述锚定机构120将作用力传递至所述弹簧圈112而导致所述弹簧圈112从所述定型丝111上脱离，所述锚定机构120优选与所述定型丝111连接，并且所述锚定机构120可绕所述定型丝111的轴线旋转。
请重点参考图9，所述锚定机构120还包括套管123，所述定位部121固定设置于所述套管123上，且所述套管123具有第一内腔。所述定型丝111的一端插入所述套管123之第一内腔中，且所述第一内腔中设有第一限位部124，所述定型丝111的端部设有第二限位部(图中未标注)，所述第二限位部与所述第一限位部124相配合，以使所述定型丝111与所述套管123在轴 向上保持相对静止，但在周向上，所述定型丝111与所述套管123之间可相对转动。如此设置的好处在于，请参考图3及图10，所述封堵器100在送入血管后，所述锚定机构120需要插入所述镂空结构210内，以实现所述锚定机构120与所述支架200的连接。而所述封堵器100在输送时所述定型丝111被抻直，在血管中释放所述封堵器100后，所述定型丝111在其自身回弹力的作用下恢复至所述预定形状的过程中，定型丝111出现扭转，所述套管123能够与所述定型丝111之间通过相对转动来抵消定型丝111扭转对所述锚定机构120的姿态调整带来的不利影响，以使锚定机构120顺利进入所述支架200的所述镂空结构210中。
进一步地，如图2及图7所示，所述封堵器100还包括促栓绒毛130，所述促栓绒毛130附着于所述本体110上，以增大所述封堵器100的填充面积，促进假腔20血栓化。所述促栓绒毛130的材质可为聚对苯二甲酸乙二醇酯(PET)、聚酰胺(PA)、聚乙烯(PE)、聚丙烯(PP)、聚氨基甲酸酯(PU)或聚乳酸(PLA)等高分子材料中的至少一种。这些高分子材料被制作为300-700D的全拉伸丝或拉伸变形丝后再在所述定型丝111上缠绕两到三圈，并被所述弹簧圈112的相邻两圈夹紧定位，即可形成所述促栓绒毛130(即如图7所示)。进一步地，在所述本体110上，所述促栓绒毛130沿所述定型丝111的轴向间隔设置，且相邻两个促栓绒毛130之间的轴向间距为5mm-10mm。另外，每个所述促栓绒毛130的长度(所述促栓绒毛130从所述定型丝111上的连接点到促栓绒毛130的自由端的长度)为15mm-25mm。
请参考11a，在进行主动脉夹层的治疗时，所述封堵器100通过导入装置300植入血管。所述导入装置300具有一容纳所述封堵器100的第二内腔，所述第二内腔沿所述导入装置300的轴向延伸并具有相对的近端和远端，其中所述远端设置有解脱机构310。在将所述封堵器100植入血管中时，所述封堵器100被抻直并设置于所述第二内腔中，在一些实施例中，所述封堵器100之第一端上的球头113与所述解脱机构310连接，此时所述封堵器100从所述真腔10中输送至所述假腔20中。待所述封堵器100输送到位后，所述导入系统300释放所述封堵器100并解除所述解脱机构310与所述球头113的 连接。或者，如图11b所示，在另一些实施例中，所述封堵器100的锚定机构120与所述解脱机构310连接，此种方式中，所述封堵器100从所述假腔20中输送至所述破口30处。
图12示出了本发明第二实施例所提供的封堵器100的结构示意图，以下描述中仅介绍本实施例与第一实施例的不同之处，其他结构可与第一实施例具有相同的设置，因而此处不再赘述。
如图12所示，本实施例中，所述定型丝111缠绕成球形结构(这里的球形结构包括几何意义上的球形结构，也包括大体呈球形的结构)的外部轮廓，以使所述本体110呈球形结构。所述定型丝111的一端延伸至所述球形结构的外部以便于所述锚定机构120连接。
如图13所示，本实施例所提供的封堵器100同样可与支架200共同使用以治疗主动脉夹层。
图14示出了本发明第三实施例所提供的封堵器100的结构示意图。如图14所示，本实施例中所述定型丝111缠绕成正六面体结构的外部轮廓。如图15所示，本实施例所提供的封堵器100可与支架200一起治疗主动脉夹层。
图16a至图16c示出了本发明第四实施例所提供的封堵器100的结构示意图。如图16a至图16c所示，本实施例中所述封堵器100之所述本体110整体上呈圆锥形，其与第一实施例的区别之处在于，所述定型丝弯曲以形成多个依次连接的弧形段，在轴向上，多个所述弧形段依次布置，且相邻两个弧形段偏心设置。这样设置的好处在于，所述本体110上没有较大的空隙，使得封堵器100可以更好地封堵所述破口30。以及，从所述第一端到所述第二端，每个所述弧形段的径向尺寸逐渐增大，这样径向尺寸较小的弧形段更靠近血管壁。进一步地，每个所述弧形段都近似为圆形，所述弧形段的径向尺寸越小，在释放封堵器100时，该段的弹簧圈112越难以发生扭结，有利于提高封堵器100的使用性能。
如图17所示，本实施例所提供的封堵器100可与支架200一起用于主动脉夹层的治疗。
图18示出了本发明第五实施例所提供的封堵器100的结构示意图。如图 18所示，所述封堵器100呈球形结构，其与第二实施例的区别之处在于，所述定型丝111的一部分盘绕成球形结构的外部轮廓，所述定型丝111的另一部分盘绕于球形结构的内部空腔中。所述定型丝111的一个端部延伸至球形结构的外部，以便于与所述锚定机构120连接。
所述定型丝111盘绕呈多个弧形段，多个所述弧形段构成所述球形结构。进一步地，优选每个所述弧形段均近似为圆形。本实施例中，所述定型丝111盘绕呈球形结构，且球形结构的内部也盘绕有定型丝111，当所述弹簧圈112套设在所述定型丝111上以构成所述本体110时，所述本体110没有较大的空隙，从而有利于阻隔血流。同时球形结构的定型丝111在释放时，即便所述弧形段发生扭结，也有足够的空间供扭结的所述弧形段反转，并在定型丝111的回弹力的作用下恢复至预定位置，从而不影响本体110的整体结构而保证封堵器100的封堵效果。
如图19所示，本实施例所提供的封堵器100可与支架200共同用于主动脉夹层的治疗。
基于前述的封堵器100，本发明的另一个目的在于提供一种封堵系统，所述封堵系统用于主动脉夹层的治疗。请参考图3、图13、图15、图17及图19，所述封堵系统包括封堵器100和支架200，所述支架200定位于真腔10中并具有镂空结构210，所述封堵器100植入假腔20并定位于破口30处，且所述封堵器100上的锚定机构120插入所述镂空结构210而与所述支架200连接。
进一步地，所述封堵系统包括至少一个所述封堵器100，实际上所述支架200的长度以能够覆盖所有的所述破口30为佳，而所述封堵器100的数量可与所述破口30的数量相等，以使每一个所述破口30处都设置一个所述封堵器100以阻隔血流进入所述假腔20，促进所述假腔20的血栓化。
本发明实施例提供的封堵器100及系统，其中所述封堵器100包括本体110和锚定机构120，所述本体110包括定型丝111和弹簧圈112，所述定型丝111是具有回弹性的金属丝，并被配置为具有预定形状，所述弹簧圈112套设在所述定型丝111上以使所述本体110形成为预定形状，所述锚定机构 120设置在所述本体110上，并用于与目标物(支架200)连接。通过所述定型丝111的回弹性，使得所述本体110在释放后能够保持预定形状，以确保对所述破口30的封堵，同时所述锚定机构120用于将所述封堵器100定位在所述破口30处，避免因血流冲击造成封堵器100移位而影响封堵效果。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (15)

  1. 一种封堵器，其特征在于，包括本体，所述本体包括定型丝和弹簧圈，所述定型丝为具有回弹性的金属丝，并被配置为具有预定形状，所述弹簧圈套设在所述定型丝上，以使所述本体形成所述预定形状。
  2. 根据权利要求1所述的封堵器，其特征在于，所述封堵器还包括锚定机构，所述锚定机构与所述定型丝的一端连接，且所述锚定机构可绕所述定型丝的轴线旋转，所述锚定机构用于将所述本体固定于目标物上。
  3. 根据权利要求2所述的封堵器，其特征在于，所述定型丝盘绕成连续的曲线结构以形成所述预定形状。
  4. 根据权利要求3所述的封堵器，其特征在于，所述预定形状为螺旋形，所述定型丝沿一轴线螺旋缠绕以形成所述螺旋形。
  5. 根据权利要求3所述的封堵器，其特征在于，所述预定形状为圆锥形，所述定型丝盘绕成多个依次连接的弧形段，在所述圆锥形的轴线方向上，多个所述弧形段依次布置，且相邻两个所述弧形段偏心设置。
  6. 根据权利要求5所述的封堵器，其特征在于，在所述圆锥形的轴线方向上，所述本体具有相对的第一端和第二端，沿着所述第一端到所述第二端的方向，所述圆锥形的径向截面逐渐增大，每个所述弧形段的径向尺寸逐渐增大，所述锚定机构设置在所述第二端上。
  7. 根据权利要求3所述的封堵器，其特征在于，所述预定形状为球形或六面体形。
  8. 根据权利要求2所述的封堵器，其特征在于，所述锚定机构包括定位部，所述定位部为倒钩或固定盘，所述定位部用于与所述目标物连接。
  9. 根据权利要求8所述的封堵器，其特征在于，所述定位部上设有尖端结构，所述尖端结构用于刺入血管内壁以固定所述本体。
  10. 根据权利要求1-9中任一项所述的封堵器，其特征在于，所述封堵器还包括促栓绒毛，所述促栓绒毛附着于所述本体上。
  11. 根据权利要求10所述的封堵器，其特征在于，所述促栓绒毛缠绕在 所述定型丝上，并被所述弹簧圈夹持固定。
  12. 根据权利要求11所述的封堵器，其特征在于，至少两个所述促栓绒毛间隔地设置在所述定型丝上，在所述定型丝的轴线方向上，相邻两个所述促栓绒毛之间的距离为5mm-10mm。
  13. 根据权利要求12所述的封堵器，其特征在于，所述促栓绒毛的长度为15mm-25mm。
  14. 根据权利要求1-9中任一项所述的封堵器，其特征在于，所述弹簧圈的内径为0.5mm-1.0mm。
  15. 一种封堵系统，其特征在于，包括支架和至少一个如权利要求1-14中任一项所述的封堵器，所述封堵器与所述支架连接。
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