WO2021128939A1 - 一种夹层破口封堵系统 - Google Patents

一种夹层破口封堵系统 Download PDF

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Publication number
WO2021128939A1
WO2021128939A1 PCT/CN2020/113614 CN2020113614W WO2021128939A1 WO 2021128939 A1 WO2021128939 A1 WO 2021128939A1 CN 2020113614 W CN2020113614 W CN 2020113614W WO 2021128939 A1 WO2021128939 A1 WO 2021128939A1
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WO
WIPO (PCT)
Prior art keywords
occluder
stent
breach
dissection
tube
Prior art date
Application number
PCT/CN2020/113614
Other languages
English (en)
French (fr)
Inventor
朱清
屠春霖
陈伊璐
张广建
张兆夺
袁振宇
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
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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 JP2022539286A priority Critical patent/JP2023508444A/ja
Priority to US17/787,918 priority patent/US20230021694A1/en
Priority to BR112022012535A priority patent/BR112022012535A2/pt
Priority to EP20905343.8A priority patent/EP4082450A4/en
Priority to KR1020227025380A priority patent/KR20220119461A/ko
Publication of WO2021128939A1 publication Critical patent/WO2021128939A1/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
    • A61B17/12131—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
    • A61B17/12099—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
    • 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
    • A61B17/12027—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
    • A61B17/12131—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
    • A61B17/12131—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
    • 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
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/844—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
    • 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
    • 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
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure

Definitions

  • the invention relates to the technical field of medical devices, in particular to a dissection breach sealing system.
  • Aortic dissection refers to the fact that the blood in the aortic lumen enters the aortic media from the tear of the aortic intima to separate the media and expand along the long axis of the aorta to form the true wall of the aorta. Leave the two cavities separated.
  • AD is a critical cardiovascular disease with rapid onset, rapid progress, and extremely high mortality.
  • endovascular aortic repair EVAR
  • Most patients with aortic dissection will have multiple ruptures at the same time.
  • the principle of EVAR is to use implants to seal the proximal rupture of AD and leave the distal rupture to improve the blood supply of the vacuum cavity and false cavity blood. The flow is reduced to achieve the purpose of false cavity thrombosis.
  • false cavity tamponade that is, embolization material is filled in the false cavity, most of which is a spring coil
  • embolization material is filled in the false cavity, most of which is a spring coil
  • a treatment method in which a stent cooperates with a spring coil to embolize the breach has appeared in the prior art, and the stent and the spring coil are pre-assembled into an integrated occlusion system and then delivered to the blood vessel for release.
  • This method has the following shortcomings: the integrated blocking system has a large resistance during the release process, and in the process of adjusting the spring ring to make the spring ring enter the false cavity, it is necessary to control the two variables of the bracket and the spring ring at the same time. Operation is more difficult; in addition, the integrated plugging system can only block one breach within a certain range, and it is difficult to handle multiple breaches at the same time.
  • the purpose of the present invention is to provide a sandwich break plugging system, which has the advantages of low transport and release resistance, simple operation, and simultaneous treatment of multiple breaks.
  • the present invention provides a dissection breach occlusion system, which includes a stent and at least one occluder.
  • the dissection breach occlusion system is configured such that, before being implanted at a target location, the stent and The occlusion device is a split structure, and after being implanted in the target position, the occlusion device is connected with the stent.
  • the dissection breach occlusion system further includes a first introduction device, and the first introduction device is used to implant the occluder at the target location.
  • the first introduction device includes a preset tube and a pusher assembly
  • the preset tube has a first inner cavity penetrating axially, and the first inner cavity is used for accommodating the occluder
  • the preset tube has a first proximal end and a first distal end opposed to each other
  • the pushing assembly has a second proximal end and a second distal end opposed to each other, and the second distal end is used to extend into the first inner The first proximal end of the cavity and used to connect with the occluder.
  • the occluder includes a body and an anchoring mechanism, the body having opposite first and second ends, and the first end is provided with the anchoring mechanism;
  • the occluder When the occluder is implanted in the target position, the occluder is straightened and accommodated in the first inner cavity, and the anchoring mechanism is located at the first distal end, and the body The second end is located at the first proximal end and connected with the pushing component.
  • the occluder includes a body and an anchoring mechanism, the body having opposite first and second ends, and the first end is provided with the anchoring mechanism;
  • the occluder When the occluder is implanted in the target position, the occluder is straightened and accommodated in the first lumen, and the second end is located at the first distal end, and the anchor The fixing mechanism is located at the first proximal end and connected with the pushing assembly.
  • the first introduction device further includes an introduction sheath having an axially penetrating second lumen, the introduction sheath is used to construct the introduction path of the occluder, and the pre A catheter is placed to carry the occluder to the target position via the second lumen.
  • the dissection breach closure system further includes a second introduction device, and the second introduction device is used to implant the stent into the target location.
  • the occluder includes a body and an anchoring device, the body includes a sizing wire and a spring coil, the sizing wire is a resilient metal wire, and the sizing wire is configured to have a predetermined shape,
  • the spring loop is sleeved on the shaping wire so that the body has the predetermined shape;
  • the anchoring device is made of a resilient metal, and the anchoring device is arranged on the body and is used with The bracket is connected.
  • the anchoring device includes a positioning portion, the positioning portion is a barb or a fixed disk; the bracket has a hollow structure, and the positioning portion is used to insert the hollow structure to connect with the bracket.
  • the styling wire is coiled into a continuous curved structure to form the predetermined shape.
  • the occlusion device further includes thrombus-promoting villi, and the thrombus-promoting villi are attached to the body.
  • the stent is a cut stent or a braided stent; or the stent includes a skeleton with a perforated covering film provided on the skeleton, and the holes on the perforated covering film constitute the hollow structure.
  • the interlayer break sealing system of the present invention has the following advantages:
  • the aforementioned dissection breach occlusion system includes a stent and an occluder, and the dissection breach occlusion system is configured such that the stent and the occluder are separated before being implanted at the target position Structure, after implantation at the target location, the occluder is connected with the stent. That is to say, the stent and the occluder are connected as a whole when they are implanted in the patient and reach a predetermined position, so that the stent and the occluder can be delivered and released separately to reduce The purpose of resistance, and when the occluder enters the false cavity, only the occluder needs to be adjusted to reduce the difficulty of the operation.
  • the interlayer break sealing system further includes a first introduction device, the first introduction device includes a preset tube and a pusher assembly, according to the installation method of the occluder in the preset tube, The occluder can be transported from the true cavity to the target location, and can also be transported from the false cavity to the target location, so that the sandwich break occlusion system has a more flexible use mode.
  • Fig. 1 is a schematic structural diagram of a dissection breach sealing system according to an embodiment of the present invention. In the figure, only the stent and the occluder are shown, and the stent is connected to the occluder;
  • Figure 2 is a cross-sectional view of a blood vessel in a region where aortic dissection occurs in a patient;
  • Fig. 3 is a schematic diagram of the interlayer breach blocking system provided by an embodiment of the present invention when blocking breaches;
  • Figure 4a is a schematic structural view of the occluder of the interlayer breach occlusion system according to an embodiment of the present invention
  • Figure 4b is another structural schematic diagram of the occluder of the interlayer breach occlusion system according to an embodiment of the present invention.
  • Figure 5a is a schematic structural view of an anchoring mechanism of the occluder of the sandwich breach occlusion system according to an embodiment of the present invention
  • Figure 5b is a schematic view of another structure of the anchoring mechanism of the occluder of the sandwich breach occlusion system according to an embodiment of the present invention.
  • Figure 6a is a schematic diagram of a structure of a stent of a dissection breach sealing system according to an embodiment of the present invention
  • Fig. 6b is another structural schematic diagram of the stent of the sandwich breach sealing system according to an embodiment of the present invention.
  • Fig. 6c is a schematic diagram of still another structure of the stent of the dissection breach sealing system according to an embodiment of the present invention.
  • FIG. 7 is a schematic structural diagram of a first introduction device of the interlayer breach sealing system according to an embodiment of the present invention.
  • Fig. 8a is a partial cross-sectional view of the first introduction device of the sandwich break sealing system shown in Fig. 7, in which the second end of the body is connected with the pushing assembly;
  • Figure 8b is a partial cross-sectional view of the first introduction device of the sandwich break sealing system shown in Figure 7, in which the anchoring mechanism is connected to the pushing assembly;
  • Fig. 9 is a schematic structural view of a second introduction device of a sandwich break sealing system according to an embodiment of the present invention.
  • Figure 10 is a partial cross-sectional view of the second introduction device of the interlayer breach closure system shown in Figure 9;
  • Figures 11a-11e show a schematic diagram of the process of the sealing method of the dissection breach occlusion system according to an embodiment of the present invention.
  • the stent in the figure only covers one breach, and the occluder is removed from the false cavity. Import the target location;
  • Fig. 12 is a schematic diagram of the interlayer breach plugging system provided by an embodiment of the present invention for plugging a breach.
  • the interlayer breach plugging system plugs two breaches;
  • Figures 13a-13e are schematic diagrams of the process of the blocking method of the dissection breach blocking system according to an embodiment of the present invention.
  • the stent in the figure only covers one breach, and the occluder is introduced into the target from the true cavity position.
  • 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.
  • the specific meanings of the above-mentioned terms in the present invention can be understood according to specific situations.
  • the same or similar reference signs in the drawings 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.
  • an embodiment of the present invention provides a dissection rupture closure system, which includes an occluder 100 and a stent 200, and the number of the occluder 100 is at least one.
  • the dissection breach occlusion system is configured such that the stent 200 and the occluder 100 are separated structures before being implanted at the target location, and the dissection breach occlusion system is implanted at the target location. At this time, the bracket 200 is connected to the occluder 100.
  • FIG. 2 shows a cross-sectional view of a blood vessel in a region where an aortic dissection occurs in a patient's body.
  • the aortic intima is torn, 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 stent 200 is first delivered to the true cavity 10, and the stent 200 is used to support the true cavity 10 and compress the false cavity 20.
  • the occluder 100 is transported to the breach 30, and the false cavity 20 is filled with the occluder 100, and the breach 30 is sealed to block the entry of the false cavity 20. Blood flow promotes thrombosis of the false cavity 20.
  • the occluder 100 is connected to the bracket 200 to ensure that the occluder 100 can be held at the breach 30 and prevent the occluder 100 from being displaced under the impact of blood flow and affecting the sealing. Blocking effect.
  • the stent 200 and the occluder 100 have a split structure, so that the two can be delivered to the blood vessel and then released. , Effectively reduce the resistance during delivery and release.
  • the occluder 100 is adjusted so that the occluder 100 enters the false cavity 20, only the occluder 100 needs to be adjusted, which reduces the difficulty of operation and improves the success rate of the operation.
  • the occluder 100 includes a body 110 and an anchoring mechanism 120.
  • the body 110 includes a shaping wire (not marked in the figure) and a spring ring (not marked in the figure).
  • the shaping wire has a return An elastic metal wire, and the sizing wire is configured to have a predetermined shape, and the spring loop is sleeved on the sizing wire, so that the body 110 is formed into the predetermined shape.
  • the anchoring mechanism 120 is arranged on the body 110 and used to connect with the bracket 200.
  • the sizing wire can be made of shape memory alloy (for example, Nitinol, etc.) or other metals (for example, cobalt-chromium alloy, stainless steel, etc.), and the sizing wire is coiled in a curved structure to form the predetermined shape.
  • shape memory alloy for example, Nitinol, etc.
  • other metals for example, cobalt-chromium alloy, stainless steel, etc.
  • the sizing wire spirally surrounds an axis to form a conical spiral structure (that is, the predetermined shape is a conical spiral structure), and is shaped by heat treatment to make the The styling wire assumes the predetermined shape in a natural state.
  • the body 110 also presents the tapered spiral structure.
  • the occluder 100 will be stretched under the action of external force during the process of introducing the diseased blood vessel, and when the occluder 100 is released in the diseased blood vessel, the body 110 It can be restored to the predetermined shape under the action of the resilience of the styling wire, so as to avoid the phenomenon that the opening cannot be effectively sealed due to the loose spring coil structure.
  • the styling wire is coiled in a curvilinear structure, so that the body 110 does not have sharp bends.
  • the occluder 100 When the occluder 100 is released in a diseased blood vessel, the occluder 100 will not attack the breach 30 by scratching the blood vessel. Causes secondary damage.
  • the predetermined shape may also be in other forms.
  • the predetermined shape is a spherical shape (the body 110 is formed as a spherical shape) or a polyhedral shape (not shown in the figure).
  • the body 110 has a first end and a second end opposite to each other, and the anchoring mechanism 120 is provided on the first end.
  • the anchoring mechanism 120 has resilience, and the anchoring mechanism 120 can be made of shape memory alloy (for example, Nitinol) or other metals (for example, cobalt-chromium alloy, stainless steel, etc.).
  • the anchoring mechanism 120 includes a positioning portion 121, as shown in FIG. 5a, the positioning portion 121 may be a plurality of barbs arranged around an axis, or as shown in FIG. 5b, the positioning portion may be a fixed disk, The fixed disk may be composed of a plurality of V-shaped rods arranged in sequence around an axis.
  • the anchoring mechanism 120 is connected to the shaping wire.
  • the anchoring mechanism 120 further includes a sleeve 122, the positioning portion 121 is fixedly arranged at one end of the sleeve 122, and the other end of the sleeve 122 is sleeved on the shaping wire, and
  • the sleeve 122 and the sizing wire are kept relatively stationary in the axial direction, and at the same time, the sleeve 122 can rotate around the axis of the sizing wire.
  • the rotation of the sleeve 122 can offset the torsion effect of the shaping ribbon when the occluder 100 is released, so that the shape of the anchoring mechanism 120 can be better adjusted to ensure the anchoring mechanism 120 It can be effectively connected with the bracket 200.
  • the occlusion device 100 further includes a thrombus-promoting villi 130, which is made of polymer materials (such as PET, PA, PU, PP, etc.) , And wound on the body 110.
  • the thrombus-promoting villi 130 can increase the filling area of the occluder 100, improve the occlusion effect of the body 110, and further promote the thrombosis of the false cavity 20.
  • the bracket 200 has a hollow structure 210.
  • the stent 200 can be formed in a variety of ways.
  • the stent 200 can be a tube network structure formed by laser cutting of a shape memory alloy tube, and the meshes on it constitute the hollow structure. 210.
  • the stent 200 has self-expanding characteristics after heat setting.
  • the stent 200 may be a tubular net-like structure woven by braided wires, the meshes on it constitute the hollow structure 210, and the braided wires may be made of a shape memory alloy.
  • the stent 200 has a self-expanding characteristic after being shaped by heat treatment.
  • the stent 200 can also be a W-shaped skeleton 220 heat-set by a shape memory alloy wire, and then a perforated film is provided on the skeleton 220 by stitching or gluing. 230 and forming, wherein the holes on the perforated covering film 230 constitute the hollow structure 210.
  • the stent 200 is a self-expanding stent. After the true cavity 10 of the diseased blood vessel is implanted, the stent 200 is opened to continuously support the true cavity 10, compress the false cavity 20, and promote the false cavity 20 Thrombosis. At the same time, blood flow can pass through the stent 200 without affecting the blood supply of important branch arteries such as the abdominal trunk, superior mesenteric artery, renal artery, and intercostal artery.
  • the hollow structure 210 on the bracket 200 is also used for the anchoring mechanism 120 of the occluder 100 to pass through to realize the connection between the two.
  • the size of the hollow structure 210 should be smaller than the radial size of the anchoring mechanism 120 in a natural state, and the hollow structure 210 The size should also be larger than the radial size when the anchoring mechanism 120 is contracted under force, so that the anchoring mechanism 120 can pass through the hollow structure 210.
  • the sandwich occlusion system further includes a first introduction device 300 for transporting the occluder 100 to a target location.
  • the first introduction device 300 includes a preset tube 310 and a pushing assembly 320.
  • the preset tube 310 has a first inner cavity penetrating axially, and the first inner cavity It is used to accommodate the occluder 100 and has a first proximal end and a first distal end opposite to each other.
  • the pushing component 320 has a second proximal end and a second distal end opposite to each other, wherein the second distal end extends into the first proximal end of the first lumen and is used to connect with the occluder 100.
  • the pushing component 320 is mechanically connected to the occluder 100.
  • the pushing assembly 320 includes a first ejector tube 321 and a release tube 322, wherein the release tube 322 has a hollow structure and is sleeved outside the first ejector tube 321, and the release tube 322 Relative axial movement can be generated between the first ejector tube 321 and the first ejector tube 321.
  • the first ejector tube 321 has a third proximal end and a third distal end opposite to each other, the release tube 322 has a fourth proximal end and a fourth distal end opposite to each other, and the third ejector tube 321 has a third proximal end and a third distal end.
  • a connecting piece 323 is provided on the distal end, and the connecting piece 323 is L-shaped, so that the axial cross-section between the connecting piece 323 and the first ejection tube 321 is " ⁇ "-shaped, and the connecting piece An opening is formed on the wall where the piece 323 and the end of the first ejection tube 321 are arranged directly opposite to each other.
  • the fourth distal end of the release tube 322 may be flush with the end of the connecting member 323 away from the first ejection tube 321. At this time, the inner wall of the release tube 322 is in contact with the connecting member 323 and the first ejector tube 321. The ends of the third distal end of an ejector tube 321 collectively form a limiting area.
  • the occluder 100 is straightened and accommodated in the first cavity of the preset tube 310.
  • the anchoring mechanism of the occluder 100 120 can be located at the first distal end of the first inner cavity, and a ball head 111 can be provided on the second end of the body 110 of the occluder 100, when the ball head 111 is set in the limit zone ,
  • the occluder 100 realizes the connection with the pushing component 320.
  • the ball head 111 is arranged at the first distal end of the first inner cavity, and the anchoring mechanism 120 is arranged at the limit zone to achieve the sealing.
  • the stopper 100 is connected to the pushing component 320. According to the installation position of the occluder 100 in the preset tube 310, the occluder 100 is transported to the breach 30 via different routes, which will be described in detail later.
  • the sandwich occlusion system further includes a first handle assembly
  • the first handle assembly includes a push handle 330 and a release handle 340
  • the fourth proximal end of the release tube 322 and the The release handle 340 is connected
  • the third proximal end of the first ejection tube 321 extends along the axial direction of the release tube 322 until it passes through the release handle 340 and is connected to the push handle 330.
  • the first ejector tube 321 and the release tube 322 are pushed by the first handle assembly to move toward the first distal end at the same time to move the occluder 100 Push out from the first cavity.
  • the release tube 322 or the first ejection tube 321 is driven to move axially through the first handle assembly, so that the connecting piece 323 is removed from the release tube
  • the fourth distal end of 322 protrudes, so that the connection between the pushing assembly 320 and the occluder 100 is released.
  • the first introduction device 300 further includes an introduction sheath 350 (as shown in FIG. 11c), the introduction sheath 350 has a second lumen that penetrates axially, and the introduction sheath 350 is used to construct the The path through which the occluder 100 enters the blood vessel, that is, the preset tube 310 carries the occluder 100 from the second lumen of the introduction sheath 350 into the blood vessel and reaches the breach 30.
  • the dissection breach sealing system further includes a second introduction device 400 for transporting the stent 200 into the true cavity 10.
  • the second introduction device 400 includes a tapered head 410, an inner tube 420, a second ejector tube 430 and an outer sheath tube 440.
  • the inner tube 420 has a fifth proximal end and a fifth distal end opposite to each other
  • the second ejector tube 430 is a hollow structure and has a sixth proximal end and a sixth distal end opposite to each other
  • the outer sheath tube 440 is The hollow structure has a seventh proximal end and a seventh distal end opposite to each other.
  • the inner tube 420, the second ejector tube 430, and the outer sheath tube 440 are sequentially nested from the inside to the outside, and the fifth distal end of the inner tube 420 extends from the second ejector tube 430
  • the sixth distal end extends out and is connected to the tapered head 410, and the seventh distal end of the outer sheath tube 440 is flush with the fifth distal end of the inner tube 420.
  • a receiving area is formed between the inner tube 420, the second ejector tube 430, and the outer sheath tube 440, and the stent 200 can be sleeved on the inner tube 420 and accommodated in the receiving area. (At this time, the stent 200 is compressed by the wall of the outer sheath tube 440 to be in a compressed state).
  • the second introduction device 400 further includes a second handle assembly, and the second handle assembly includes a fixed handle 450 and a release handle 460.
  • the fixed handle 450 is connected to the fifth proximal end of the inner tube 420 and the sixth proximal end of the second ejector tube 430
  • the release handle 460 is connected to the seventh proximal end of the outer sheath tube 440 .
  • the fixed handle 450 and the release handle 460 are relatively rotatable, and the release handle 460 can drive the outer sheath tube 440 with respect to the inner tube 420 and the second ejector tube 430 through a spiral transmission mechanism. The axial movement can release the stent 200.
  • the occluder 100 has two different settings in the preset tube 310. According to the different setting methods, there are two types of delivery when the dissection breach occlusion system is delivered to the diseased blood vessel. The method is described in detail below in conjunction with the accompanying drawings.
  • Step S1 using the second introducing device 400 to introduce the stent 200 into the true cavity 10 of the diseased blood vessel (as shown in Fig. 11a).
  • step S2 the outer sheath tube 440 is retracted to release the stent 200 so that the stent 200 covers at least one of the breaches 30 (as shown in Fig. 11b).
  • Step S3 using the first introducing device 300 to introduce the occluder 100 into the breach 30.
  • the introduction sheath 350 is first made to reach one of the breaches 30 through the false cavity 20 (as shown in FIG. 11c), and then the preset tube 310 carries the occluder 100 from the The second lumen of the introduction sheath 350 reaches the breach 30 (as shown in Fig. 11d).
  • Step S4 the pushing component 320 pushes the occluder 100 so that the anchoring mechanism 120 is released first, and the anchoring mechanism 120 passes through the breach 30 and the hollow structure 210 on the stent 200 to enter Go into the stent 200 and connect with the stent 200, and then continue to release the occluder 100 (as shown in FIG. 11e).
  • Step S5 release the connection between the occluder 100 and the pushing component 320. Specifically, the release tube 322 or the first ejection tube 321 is driven to move axially through the first handle assembly, so that the connecting member 323 protrudes from the fourth distal end of the release tube 322 At this time, the body 110 can be separated from the pushing assembly under the action of the resilience of the styling wire (this is actually a mechanical release method).
  • the occluder 100 and the pushing assembly 320 may also be connected in other ways. According to the different connection methods, the occluder 100 and the pushing component 320 are removed by electrolysis (the occluder 100 and the pushing component 320 are connected by a wire), and the occluder 100 and the pushing component 320 are disconnected by heat (at this time, the The occluder 100 and the pushing component 200 can be connected by polymer filaments or released by hydrolysis. It can be understood that the electrolytic desorption, thermal fusion desorption and hydrolysis desorption are all existing technologies that are familiar to those skilled in the art.
  • each interlayer breach blocking system may include two, three or even More occluders 100 are determined according to the patient's condition.
  • the method of use is basically the same as that described above, except that the steps S3 and S4 are repeated according to the number of occluders 100.
  • Fig. 12 shows the use situation of the sandwich break occlusion system with two occluders 100. At this time, the step S3 and the step S4 are performed twice.
  • the bracket 200 covers all the breaches 30, and the number of the occluders 100 is the same as the number of the breaches 30, so that each of the breaches 30 can be blocked .
  • Step S10 using the second introducing device 400 to introduce the stent 200 into the true cavity 10 of the diseased blood vessel (as shown in FIG. 13a).
  • step S20 the outer sheath tube 440 is retracted to release the stent 200 so that the stent 200 covers at least one of the breaches 30 (as shown in FIG. 13b).
  • Step S30 using the first introducing device 300 to introduce the occluder 100 to the breach 30.
  • the introduction sheath 350 passes through the true cavity 10 and the inside of the stent 200, and passes through the hollow structure 210 to reach the breach 30 (as shown in FIG. 13c), Then the preset tube 310 carries the occluder 100 from the second lumen of the introduction sheath 350 to the breach 30 (as shown in FIG. 13d).
  • step S40 the pushing component 320 pushes the occluder 100 so that the second end of the body 110 of the occluder 100 is released first, so that the occluder 100 partially penetrates the breach 30. Enter the false cavity 20. After that, the occluder 100 is continuously released until the anchoring mechanism 120 is released and connected with the stent 200 (as shown in FIG. 13e).
  • connection mode of the pushing component 320 and the occluder 100 select a suitable release method (ie any one of mechanical release, electrolytic release, thermal fusion release or hydrolytic release) to release the occluder 100 Connection with the push component 320.
  • a suitable release method ie any one of mechanical release, electrolytic release, thermal fusion release or hydrolytic release
  • step S30 and the step S40 are repeated according to the number of the occluder 100 in the interlayer breach occlusion system.
  • method one or method two can be used alone according to the actual situation, or the two methods can be used in combination.
  • the dissection breach occlusion system includes a stent and an occluder, and the dissection breach occlusion system is configured such that, before being implanted at a target position, the stent and the occluder are In a split structure, the occluder is connected to the stent after being implanted at the target position. That is to say, the stent and the occluder are connected as a whole when they are implanted in the patient and reach a predetermined position, so that the stent and the occluder can be delivered and released separately to reduce resistance And when the occluder enters the false cavity, only the occluder needs to be adjusted to reduce the difficulty of the operation.
  • one stent can be used with multiple occluders, so as to achieve the purpose of processing all the breaches at one time at the same time.

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Abstract

一种夹层破口封堵系统，包括支架(200)和至少一个封堵器(100)，夹层破口封堵系统被配置为，在植入目标位置之前，支架(200)和封堵器(100)为分体式结构，在植入目标位置之后，封堵器(100)与支架(200)连接。支架(200)和封堵器(100)分别输送至病变血管中进行释放，有效降低支架(200)和封堵器(100)输送和释放时的阻力，同时在使封堵器(100)进入假腔(20)时，仅需对封堵器(100)的形态进行调整，降低了操作难度，提高手术成功率。

Description

一种夹层破口封堵系统 技术领域
本发明涉及医疗器械技术领域，具体涉及一种夹层破口封堵系统。
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。大部分的主动脉夹层患者会同时并发多处破口，而EVAR的原理是采用植入物封堵AD的近端破口，旷置远端破口，通过真空腔血供改善、假腔血流减少来达到假腔血栓化的目的。
理论上，为了获得更佳的主动脉重塑及远期预后，有必要同期或者分期处理主动脉夹层远端破口。然而，现有技术中主动脉夹层远端破口介入治疗面临的问题是：(1)主动脉夹层远端破口数量多且复杂，绝大多数的患者存在三个以上的远端破口，处理困难。(2)主动脉夹层远端破口在腹主动脉脏器区域的占比高，这一区域由于分支动脉的存在，腔内治疗困难。由于远端破口的存在假腔血栓化并不能达到理想状态，部分患者的假腔仍开放且持续增大以致形成动脉瘤。
目前，临床上常使用假腔填塞术(即在假腔中填充栓塞材料，栓塞材料大多为弹簧圈)促进假腔血栓化。由于假腔体积大且远端破口多，假腔填塞术需要使用大量的弹簧圈，术中操作困难且医疗费用高昂。此外，传统的弹簧圈释放后没有固定装置，使得弹簧圈在假腔内存在移位的风险。针对于此，现有技术中出现了支架配合弹簧圈栓塞破口的治疗方式，且支架和弹簧圈被预先组装成一体式封堵系统后，再输送至血管中进行释放。这种方式存在以下缺点：一体式的封堵系统在释放过程中存在较大的阻力，且在调整弹簧圈以使弹簧圈进入假腔的过程中，需要同时控制支架和弹簧圈两个变量，操作难度加大；另外，一体式的封堵系统在一定范围内仅能实现一个破口的封堵，难以同时处理多个破口。
发明内容
本发明的目的在于提供一种夹层破口封堵系统，该夹层破口封堵系统具有输送和释放阻力小、操作简单、可同时处理多个破口的优点。
为实现上述目的，本发明提供的一种夹层破口封堵系统，包括支架和至少一个封堵器，所述夹层破口封堵系统被配置为，在植入目标位置之前，所述支架和所述封堵器为分体式结构，在植入目标位置之后，所述封堵器与所述支架连接。
可选地，所述夹层破口封堵系统还包括第一导入装置，所述第一导入装置用于将所述封堵器植入所述目标位置。
可选地，所述第一导入装置包括预置管和推送组件，所述预置管具有轴向贯通的第一内腔，所述第一内腔用于容置所述封堵器，并且所述预置管具有相对的第一近端和第一远端；所述推送组件具有相对的第二近端和第二远端，所述第二远端用于伸入所述第一内腔的第一近端，并用于与所述封堵器连接。
可选地，所述封堵器包括本体和锚定机构，所述本体具有相对的第一端和第二端，所述第一端设置有所述锚定机构；
在将所述封堵器植入目标位置时，所述封堵器被抻直并容置于所述第一内腔中，且所述锚定机构位于所述第一远端，所述本体之第二端位于所述第一近端并与所述推送组件连接。
可选地，所述封堵器包括本体和锚定机构，所述本体具有相对的第一端和第二端，所述第一端设置有所述锚定机构；
在将所述封堵器植入目标位置时，所述封堵器被抻直并容置于所述第一内腔中，且所述第二端位于所述第一远端，所述锚定机构位于所述第一近端并与所述推送组件连接。
可选地，所述第一导入装置还包括导入鞘管，所述导入鞘管具有轴向贯通的第二内腔，所述导入鞘管用于构建所述封堵器的导入路径，所述预置管携带所述封堵器经由所述第二内腔到达所述目标位置。
可选地，所述夹层破口封堵系统还包括第二导入装置，所述第二导入装 置用于将所述支架植入所述目标位置。
可选地，所述封堵器包括本体和锚定装置，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，且所述定型丝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具有所述预定形状；所述锚定装置由具有回弹性的金属制作，所述锚定装置设置于所述本体上，并用于与所述支架连接。
可选地，所述锚定装置包括定位部，所述定位部为倒钩或固定盘；所述支架具有镂空结构，所述定位部用于插入所述镂空结构而与所述支架连接。
可选地，所述定型丝盘绕成连续曲线结构，以形成所述预定形状。
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，所述支架为切割支架或编织支架；或所述支架包括骨架，所述骨架上设置有带孔覆膜，所述带孔覆膜上的孔洞构成所述镂空结构。
与现有技术相比，本发明的夹层破口封堵系统具有如下优点：
第一、前述的夹层破口封堵系统包括支架和封堵器，且所述夹层破口封堵系统被配置为，在植入目标位置之前，所述支架和所述封堵器为分体式结构，在植入目标位置之后，所述封堵器与所述支架连接。也就是说，所述支架和所述封堵器是在植入患者体内并到达预定位置时才连接为一体，这样使得所述支架和所述封堵器可单独输送、释放，以达到减小阻力的目的，并且在使封堵器进入假腔时仅需对封堵器进行调节而降低手术操作的难度。
第二、所述夹层破口封堵系统还包括第一导入装置，所述第一导入装置包括预置管和推送组件，根据所述封堵器在所述预置管中的安装方式，所述封堵器既可以从真腔中输送至目标位置，也可以从假腔中输送至目标位置，使得所述夹层破口封堵系统具有更加灵活的使用方式。
附图说明
图1是本发明根据一实施例所提供的夹层破口封堵系统的结构示意图，图中仅示出支架和封堵器，且支架与封堵器连接；
图2是患者体内发生主动脉夹层区域的血管的剖视图；
图3是本发明根据一实施例所提供的夹层破口封堵系统封堵破口时的示 意图；
图4a是本发明根据一实施例所提供的夹层破口封堵系统之封堵器的一种结构示意图；
图4b是本发明根据一实施例所提供的夹层破口封堵系统之封堵器的另一种结构示意图；
图5a是本发明根据一实施例所提供的夹层破口封堵系统之封堵器的锚定机构一种结构示意图；
图5b是本发明根据一实施例所提供的夹层破口封堵系统之封堵器的锚定机构另一种结构示意图；
图6a是本发明根据一实施例所提供的夹层破口封堵系统之支架的一种结构示意图；
图6b是本发明根据一实施例所提供的夹层破口封堵系统之支架的另一种结构示意图；
图6c是本发明根据一实施例所提供的夹层破口封堵系统之支架的再一种结构示意图；
图7是本发明根据一实施例所提供的夹层破口封堵系统之第一导入装置的结构示意图；
图8a是图7所示的夹层破口封堵系统之第一导入装置的局部剖视图，图中本体的第二端与推送组件连接；
图8b是图7所示的夹层破口封堵系统之第一导入装置的局部剖视图，图中锚定机构与推送组件连接；
图9是本发明根据一实施例所提供的的夹层破口封堵系统之第二导入装置的结构示意图；
图10是图9所示的夹层破口封堵系统之第二导入装置的局部剖视图；
图11a-图11e示出了本发明根据一实施例所提供的夹层破口封堵系统的封堵方法的过程示意图，图示中的支架仅覆盖了一个破口，且封堵器从假腔中导入目标位置；
图12是本发明根据一实施例所提供的夹层破口封堵系统封堵破口的示意 图，图示中的夹层破口封堵系统封堵了两个破口；
图13a-图13e是本发明根据一实施例所提供的夹层破口封堵系统的封堵方法的过程示意图，图示中的支架仅覆盖一个破口，且封堵器从真腔中导入目标位置。
[附图标记说明如下]：
100-封堵器；
110-本体；
111-球头；
120-锚定机构；
121-定位部，122-套管；
130-促栓绒毛；
200-支架；
210-镂空结构，220-骨架，230-带孔覆膜；
300-第一导入装置；
310-预置管；
320-推送组件；
321-第一顶出管，322-解脱管，323-连接件；
330-推送手柄；
340-解脱手柄；
350-导入鞘管；
400-第二导入装置；
410-锥形头，420-内管，430-第二顶出管，440-外鞘管，450-固定手柄，460-释放手柄；
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。
请参考图1，本发明实施例提供了一种夹层破口封堵系统，包括封堵器100和支架200，所述封堵器100的数量至少为一个。所述夹层破口封堵系统被配置为，在植入目标位置之前，所述支架200和所述封堵器100为分体式结构，而在将所述夹层破口封堵系统植入目标位置时，使所述支架200与所述封堵器100连接。
请参考图2，图2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2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。利用所述夹层破口封堵系统进行主动脉夹层的治疗时，首先将所述支架200输送至所述真腔10中，利用所述支架200支撑所述真腔10，并压迫所述假腔20。之后再将所述封堵器100输送至所述破口30处，使用所述封堵器100填塞所述假腔20，并封堵所述破口30，以阻隔进入所述假腔20的血流，促进所述假腔20血栓化。同时使所述封堵器100与所述支架200连接，以确保所述封堵器100可保持于所述破口30处，避免所述封堵器100在血流冲击下移位而影响封堵效果。
本实施例中，在将所述夹层破口封堵系统植入病变血管之前，所述支架200和所述封堵器100为分体式结构，这样使得两者可分别输送至血管中再进行释放，有效减小输送和释放时的阻力。同时，在调整所述封堵器100以使所述封堵器100进入所述假腔20时，仅需对所述封堵器100进行调整，降低了操作难度，提高手术成功率。
下面将结合附图介绍所述夹层破口封堵系统的具体结构。
请参考图4a，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(图中未标注)和弹簧圈(图中未标注)，所述定型丝为具有回弹性的金属丝，且所述定型丝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110形成为所述预定形状。所述锚定机构120设置于所述本体110上，并用于与所述支架200连接。
其中，所述定型丝可采用形状记忆合金(例如镍钛合金等)或其他金属(例如钴铬合金、不锈钢等)制作而成，所述定型丝盘绕呈曲线结构以形成所述预定形状。如图4a所示，在一个实施例中，所述定型丝沿一轴线螺旋环绕而形成锥形的螺旋结构(即所述预定形状为锥形的螺旋结构)，并通过热处理定型，以使所述定型丝在自然状态下呈现所述预定形状。当所述弹簧圈套设在所述定型丝上时，所述本体110亦呈现所述锥形的螺旋结构。这样设置的好处在于，首先，所述封堵器100在导入病变血管的过程中会在外力的作用下被抻直，而当所述封堵器100在病变血管中释放后，所述本体110可在所述定型丝的回弹力作用下恢复至所述预定形状，从而避免因弹簧圈结构松散而不能有效封堵破口的现象。其次，所述定型丝盘绕呈曲线结构，使得所述本体110没有尖锐的折角，所述封堵器100在病变血管中释放时，所述封堵器100不会因剐蹭血管而对破口30造成二次伤害。在另一些实施例中，所述预定形状也可以是其他形式，例如，如图4b所示，所述预定形状为球形(所述本体110形成为球形)或多面体形(图中未示出)。另外，所述本体110具有相对的第一端和第二端，所述第一端上设有所述锚定机构120。
所述锚定机构120具有回弹性，所述锚定机构120可采用形状记忆合金(例如镍钛合金)或其他金属(例如钴铬合金、不锈钢等)制作而成。所述 锚定机构120包括定位部121，如图5a所示，所述定位部121可以是环绕一轴线布置的多个倒钩，或者如图5b所示，所述定位部可以是固定盘，所述固定盘可由多个呈V形的杆体围绕一轴线依次布置构成。当所述定位部121受到指向所述轴线的作用力时，所述定位部121朝向所述轴线收缩以减小所述锚定机构120的体积，而当所述作用力取消时，所述定位部121又可恢复原状。
进一步地，如图5a、5b所示，所述锚定机构120与所述定型丝连接。具体地，所述锚定机构120还包括套管122，所述定位部121固定设置于所述套管122的一端，所述套管122的另一端套设在所述定型丝上，且所述套管122与所述定型丝在轴向上保持相对静止，同时所述套管122可绕所述定型丝的轴线旋转。通过所述套管122的旋转以抵消所述封堵器100在释放时所述定型丝带来的扭转效应，从而可更好地调整所述锚定机构120的形态，确保所述锚定机构120与所述支架200能够有效连接。
可选地，如图4a及图4b所示，所述封堵器100还包括促栓绒毛130，所述促栓绒毛130由高分子材料(例如PET、PA、PU、PP等)制作而成，并缠绕于所述本体110上。所述促栓绒毛130可起到增大封堵器100的填充面积，改善所述本体110的封堵效果，进一步促进假腔20的血栓化。
请参考图6a至图6c，所述支架200具有镂空结构210。该支架200可通过多种方式成型，例如，如图6a所示，所述支架200可以是由形状记忆合金管材经激光切割形成的管网状结构，其上的网孔即构成所述镂空结构210。所述支架200经热定型而具有自膨胀的特性。又如，如图6b所示，所述支架200可以是编织丝编织而成的管网状结构，其上的网孔构成所述镂空结构210，所述编织丝可由形状记忆合金制作。同样地，所述支架200经由热处理定型而具有自膨胀的特性。再如，如图6c所示，所述支架200还可以是由形状记忆合金丝材热定型呈W形的骨架220，然后在所述骨架220上通过缝合或胶粘的方式设置带孔覆膜230而成型，其中所述带孔覆膜230上的孔洞即构成所述镂空结构210。
所述支架200为自膨式支架，在植入病变血管的所述真腔10后，所述支 架200打开以持续支撑所述真腔10，压迫所述假腔20，促进所述假腔20血栓化。同时血流可从所述支架200中穿过而不影响腹腔干、肠系膜上动脉、肾动脉、肋间动脉等重要分支动脉的血供。另外，所述支架200上的镂空结构210还用于供所述封堵器100之锚定机构120穿过而实现两者的连接。可理解，为使所述锚定机构120与所述支架200有效连接，所述镂空结构210的尺寸应当小于所述锚定机构120在自然状态下的径向尺寸，且所述镂空结构210的尺寸还应大于所述锚定机构120受力收缩时的径向尺寸，以使所述锚定机构120能穿过所述镂空结构210。
进一步地，所述夹层封堵系统还包括第一导入装置300，所述第一导入装置300用于将所述封堵器100输送至目标位置。具体地，请参考图7和图8a，所述第一导入装置300包括预置管310和推送组件320，所述预置管310具有轴向贯通的第一内腔，所述第一内腔用于容纳所述封堵器100，并具有相对的第一近端和第一远端。所述推送组件320具有相对的第二近端和第二远端，其中所述第二远端伸入所述第一内腔的第一近端，并用于与所述封堵器100连接。
在一个实施例中，所述推送组件320与所述封堵器100机械连接。具体地，所述推送组件320包括第一顶出管321和解脱管322，其中所述解脱管322为中空结构并套设在所述第一顶出管321的外部，且所述解脱管322与所述第一顶出管321之间可产生相对的轴向运动。所述第一顶出管321具有相对的第三近端和第三远端，所述解脱管322具有相对的第四近端和第四远端，所述第一顶出管321的第三远端上设置有连接件323，所述连接件323呈L形，以使所述连接件323与所述第一顶出管321之间的轴向截面为“П”形，且所述连接件323与所述第一顶出管321的端部正对设置的壁上形成有开口。所述解脱管322的第四远端可与所述连接件323远离所述第一顶出管321的一端齐平，此时所述解脱管322的内壁与所述连接件323及所述第一顶出管321的第三远端的端部共同形成限位区。可选地，如图8a所示，所述封堵器100被抻直后容置于所述预置管310的第一内腔中，根据实际需要，所述封堵器100的锚定机构120可位于所述第一内腔的第一远端，所述封堵器100之 本体110的第二端上可设置一球头111，当所述球头111设置于所述限位区时，所述封堵器100实现与所述推送组件320的连接。或者，如图8b所示，将所述球头111设置于所述第一内腔之第一远端，而将所述锚定机构120设置于所述限位区时也可实现所述封堵器100与所述推送组件320的连接。根据所述封堵器100在所述预置管310中的设置方位，所述封堵器100经不同的路线输送至所述破口30处，后文中将对此做详细介绍。
进一步地，如图9所示，所述夹层封堵系统还包括第一手柄组件，所述第一手柄组件包括推送手柄330和解脱手柄340，所述解脱管322的第四近端与所述解脱手柄340连接，所述第一顶出管321的第三近端沿所述解脱管322的轴向延伸，直至穿出所述解脱手柄340后与所述推送手柄330连接。在释放所述封堵器100时，通过所述第一手柄组件推动所述第一顶出管321和所述解脱管322同时朝向所述第一远端移动，以将所述封堵器100从所述第一内腔中推出。待所述封堵器100完全释放后，再通过所述第一手柄组件驱动所述解脱管322或所述第一顶出管321轴向运动，以使所述连接件323从所述解脱管322的第四远端伸出，从而解除所述推送组件320与所述封堵器100的连接。
另外，所述第一导入装置300还包括导入鞘管350(如图11c所示)，所述导入鞘管350具有轴向贯通的第二内腔，且所述导入鞘管350用于构建所述封堵器100进入血管的路径，即所述预置管310携带所述封堵器100从所述导入鞘管350的第二内腔进入血管并到达所述破口30处。
进一步地，所述夹层破口封堵系统还包括第二导入装置400，所述第二导入装置400用于将所述支架200输送至所述真腔10中。如图9及图10所示，所述第二导入装置400包括锥形头410、内管420、第二顶出管430和外鞘管440。所述内管420具有相对的第五近端和第五远端，所述第二顶出管430为中空结构并具有相对的第六近端和第六远端，所述外鞘管440为中空结构并具有相对的第七近端和第七远端。所述内管420、所述第二顶出管430及所述外鞘管440由内向外依次嵌套设置，且所述内管420的第五远端从所述第二顶出管430的第六远端伸出，并与所述锥形头410连接，所述外鞘管440的 第七远端与所述内管420的第五远端齐平。这样所述内管420、所述第二顶出管430及所述外鞘管440之间形成容纳区，所述支架200可套设在所述内管420上，并容置于所述容纳区内(此时所述支架200被所述外鞘管440的壁压迫而呈压缩态)。
可选地，所述第二导入装置400还包括第二手柄组件，所述第二手柄组件包括固定手柄450和释放手柄460。所述固定手柄450与所述内管420的第五近端及所述第二顶出管430的第六近端连接，所述释放手柄460与所述外鞘管440的第七近端连接。所述固定手柄450与所述释放手柄460可相对旋转，并且所述释放手柄460可通过螺旋传动机构带动所述外鞘管440相对于所述内管420及所述第二顶出管430做轴向运动，进而可释放所述支架200。可理解，对于本领域技术人员而言，利用释放手柄460带动所述外鞘管440相对于所述内管420和所述第二顶出管430做轴向运动是公知常识，因而此处不做详细介绍。
如前所述，所述封堵器100在预置管310有两种不同的设置方式，根据设置方式的不同，在将所述夹层破口封堵系统输送至病变血管中时有两种输送方法，以下结合附图详细介绍。
方法一、当所述封堵器100的球头111设置于所述限位区而与所述推送组件320连接时，所述夹层破口封堵系统的输送方法如下：
步骤S1，利用所述第二导入装置400将所述支架200导入病变血管的所述真腔10内(如图11a所示)。
步骤S2，回撤所述外鞘管440以释放所述支架200，使所述支架200至少覆盖一个所述破口30(如图11b所示)。
步骤S3，利用所述第一导入装置300将所述封堵器100导入所述破口30处。具体地，首先使所述导入鞘管350经由所述假腔20到达一个所述破口30处(如图11c所示)，然后所述预置管310携带所述封堵器100从所述导入鞘管350的第二内腔到达所述破口30处(如图11d所示)。
步骤S4，所述推送组件320推送所述封堵器100，使所述锚定机构120首先释放，所述锚定机构120穿过所述破口30及所述支架200上的镂空结构 210进入到所述支架200内，并与所述支架200连接，之后继续释放所述封堵器100(如图11e所示)。
步骤S5：解除所述封堵器100与所述推送组件320的连接。具体地，通过所述第一手柄组件驱动所述解脱管322或所述第一顶出管321作轴向运动，以使所述连接件323从所述解脱管322的第四远端伸出，此时所述本体110在所述定型丝的回弹力的作用下即可脱离所述推送组件(这实际上是一种机械解脱方式)。
在其他实施例中，所述封堵器100与所述推送组件320还可通过其他方式连接。根据连接方式的不同，所述封堵器100与所述推送组件320通过电解脱(此时所述封堵器100与所述推送组件320通过金属丝连接)、热熔解脱(此时所述封堵器100与所述推送组件200可通过高分子丝连接)或水解脱的方式解除连接。可理解，所述电解脱、热熔解脱及水解脱都是本领域技术人员可习知的现有技术。
另外，在上述使用方法中仅介绍了所述夹层破口封堵系统有一个所述封堵器100的情况，实际上，每个所述夹层破口封堵系统可包括两个、三个甚至更多个所述封堵器100，具体根据患者的情况而定。当所述夹层破口系统具有多个所述封堵器100时，其使用方法与前述基本相同，不同之处仅在于根据所述封堵器100的数量重复所述步骤S3、所述步骤S4及所述步骤S5。图12即示出了所述夹层破口封堵系统具有两个所述封堵器100时的使用情况，此时所述步骤S3和所述步骤S4进行了两次。较佳地，所述支架200覆盖所有的所述破口30，且所述封堵器100的数量与所述破口30的数量相同，以使每一个所述破口30均可被封堵。
方法二、当所述封堵器100的锚定机构120设置于所述限位区而与所述推送组件320连接时，所述夹层破口封堵系统的输送方法如下：
步骤S10，利用所述第二导入装置400将所述支架200导入病变血管的所述真腔10内(如图13a所示)。
步骤S20，回撤所述外鞘管440以释放所述支架200，使所述支架200至少覆盖一个所述破口30(如图13b所示)。
步骤S30，利用所述第一导入装置300将所述封堵器100导入至所述破口30处。具体地，首先使所述导入鞘管350经由所述真腔10及所述支架200的内部，并穿过所述镂空结构210而到达一个所述破口30处(如图13c所示)，然后所述预置管310携带所述封堵器100从所述导入鞘管350的所述第二内腔到达所述破口30处(如图13d所示)。
步骤S40，所述推送组件320推送所述封堵器100，使所述封堵器100之本体110的第二端首先释放，以使所述封堵器100部分穿过所述破口30而进入所述假腔20。之后继续释放所述封堵器100，直至所述锚定机构120释放并与所述支架200连接(如图13e所示)。
最后根据所述推送组件320与所述封堵器100的连接方式，选择合适的解脱方法(即机械解脱、电解脱、热熔解脱或水解脱中的任一种)解除所述封堵器100与所述推送组件320的连接。
同理，所述步骤S30和所述步骤S40根据所述夹层破口封堵系统中的所述封堵器100的数量重复进行。
每次进行主动脉夹层的治疗时，可根据实际情况单独使用方法一或方法二，也可以两种方法结合使用。
本发明实施例所提供的夹层破口封堵系统包括支架和封堵器，且所述夹层破口封堵系统被配置为，在植入目标位置之前，所述支架和所述封堵器为分体式结构，在植入目标位置之后，所述封堵器与所述支架连接。也就是说，所述支架和所述封堵器是在植入患者体内并到达预定位置时才连接为一体，这样使得所述支架和所述封堵器可单独输送、释放，以减小阻力，并且在使封堵器进入假腔时仅需对封堵器进行调节而降低手术操作的难度。同时一个所支架可搭配多个所述封堵器使用，以达到同期一次性处理所有破口的目的。
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 (12)

  1. 一种夹层破口封堵系统，其特征在于，包括支架和至少一个封堵器，所述夹层破口封堵系统被配置为，在植入目标位置之前，所述支架和所述封堵器为分体式结构，在植入目标位置之后，所述封堵器与所述支架连接。
  2. 根据权利要求1所述的夹层破口封堵系统，其特征在于，还包括第一导入装置，所述第一导入装置用于将所述封堵器植入所述目标位置。
  3. 根据权利要求2所述的夹层破口封堵系统，其特征在于，所述第一导入装置包括预置管和推送组件，所述预置管具有轴向贯通的第一内腔，所述第一内腔用于容置所述封堵器，并且所述预置管具有相对的第一近端和第一远端；所述推送组件具有相对的第二近端和第二远端，所述第二远端用于伸入所述第一内腔的第一近端，并用于与所述封堵器连接。
  4. 根据权利要求3所述的夹层破口封堵系统，其特征在于，所述封堵器包括本体和锚定机构，所述本体具有相对的第一端和第二端，所述第一端设置有所述锚定机构；
    在将所述封堵器植入目标位置时，所述封堵器被抻直并容置于所述第一内腔中，且所述锚定机构位于所述第一远端，所述本体的第二端位于所述第一内腔的所述第一近端并与所述推送组件连接。
  5. 根据权利要求3所述的夹层破口封堵系统，其特征在于，所述封堵器包括本体和锚定机构，所述本体具有相对的第一端和第二端，所述第一端设置有所述锚定机构；
    在将所述封堵器植入目标位置时，所述封堵器被抻直并容置于所述第一内腔中，且所述本体的第二端位于所述第一内腔的所述第一远端，所述锚定机构位于所述第一内腔的所述第一近端并与所述推送组件连接。
  6. 根据权利要求3所述的夹层破口封堵系统，其特征在于，所述第一导入装置还包括导入鞘管，所述导入鞘管具有轴向贯通的第二内腔，所述导入鞘管用于构建所述封堵器的导入路径，所述预置管携带所述封堵器经由所述第二内腔到达所述目标位置。
  7. 根据权利要求1-6中任一项所述的夹层破口封堵系统，其特征在于，还包括第二导入装置，所述第二导入装置用于将所述支架植入所述目标位置。
  8. 根据权利要求1所述的夹层破口封堵系统，其特征在于，所述封堵器包括本体和锚定装置，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，且所述定型丝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具有所述预定形状；所述锚定装置主要由具有回弹性的金属制作，所述锚定装置设置于所述本体上，并用于与所述支架连接。
  9. 根据权利要求8所述的夹层破口封堵系统，其特征在于，所述锚定装置包括定位部，所述定位部为倒钩或固定盘；所述支架具有镂空结构，所述定位部用于插入所述镂空结构而与所述支架连接。
  10. 根据权利要求8所述的夹层破口封堵系统，其特征在于，所述定型丝盘绕成连续曲线结构，以形成所述预定形状。
  11. 根据权利要求8所述的夹层破口封堵系统，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。
  12. 根据权利要求9所述的夹层破口封堵系统，其特征在于，所述支架为切割支架或编织支架；或，所述支架包括骨架，所述骨架上设置有带孔覆膜，所述带孔覆膜上的孔洞构成所述镂空结构。
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