CN112842619A - Bow covered stent and covered stent conveyor - Google Patents

Bow covered stent and covered stent conveyor Download PDF

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Publication number
CN112842619A
CN112842619A CN202110336916.4A CN202110336916A CN112842619A CN 112842619 A CN112842619 A CN 112842619A CN 202110336916 A CN202110336916 A CN 202110336916A CN 112842619 A CN112842619 A CN 112842619A
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China
Prior art keywords
stent
stent graft
arch
film
bracket
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Granted
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CN202110336916.4A
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Chinese (zh)
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CN112842619B (en
Inventor
董永贺
刘颖
杜庆庆
李飞
郑殿会
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Beijing Percutek Therapeutics Co ltd
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Beijing Percutek Therapeutics Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/072Encapsulated stents, e.g. wire or whole stent embedded in lining
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91575Adjacent bands being connected to each other connected peak to trough
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Prostheses (AREA)

Abstract

The invention provides an arch part film-coated support and a film-coated support conveyor, which relate to the field of medical instruments and comprise a film and a metal support; wherein: the tectorial membrane is provided with a windowing used for supplying blood for the bow branch blood vessel; the metal bracket comprises a first bracket and a second bracket; the first bracket comprises at least one metal ring, the metal ring is fixedly connected to the covering film, and the far end of the first bracket is positioned on one side of the near end of the window; the second stent is in a net cylinder shape, is positioned in the covering film and at the far end of the first stent, and covers the fenestration in the covering film under the release state; the proximal end of the second stent is connected to the distal end of the first stent and/or connected to the covering membrane; and a developing part is arranged on the covering film or the second bracket around the opening window. The invention solves the technical problem that the existing covered stent is not beneficial to the application of the intracavity interventional operation on the A-type interlayer or the aneurysm of the affected arch part.

Description

Bow covered stent and covered stent conveyor
Technical Field
The invention relates to the technical field of medical instruments, in particular to an arch part covered stent and a covered stent conveyor.
Background
The aortic disease is a group of cardiovascular diseases seriously threatening human health, including aortic dissection, aortic aneurysm and the like, mainly caused by hypertension, arteriosclerosis, injury, infection and other reasons, has great threat to the life of a patient, especially has wide range of pathological changes, influences the aortic dissection of brain, spinal cord and multi-organ blood supply, has large operation trauma, complicated operation, long time, much blood consumption, and higher complication incidence rate and operation death rate of the operation. The reconstruction of the blood supply of the aorta and its branch arteries in as short a time as possible has always been the goal sought by vascular surgeons.
The diseased position of the aortic dissection is a core factor for determining the operation mode, the B-type dissection or aneurysm with a broken opening positioned in descending aorta usually adopts the aortic intracavity repair technology with small wound and high success rate, the delivery system loaded with the covered stent is pushed to the diseased part through the aorta far end such as a femoral artery incision of a human body, the covered stent is released and fixed, the diseased aneurysm or the dissection is isolated, and a blood transport channel is reconstructed, so that the treatment purpose is achieved. However, for the more violent A-type dissecting or aneurysm involving the arch part, because the branch vessels are involved and the difference of the physiological planning resolving structures of the patients is large, if a minimally invasive endovascular intervention isolation operation is adopted, the aortic vessel stent used in the current intraluminal interventional therapy needs an anchoring area of at least 15mm near the heart, when the current stent is applied to the treatment, the branch vessels are blocked in different degrees, the blood flow of the branch arteries is obstructed, corresponding complications occur and even the life can be endangered, at present, the problem of arch part vessel reconstruction can be solved through the arch part stent windowing technology, the chimney technology and the like clinically, but because the physiological structures of 3 branch vessels of the aortic arch part of each patient are different, the windowing technology and the chimney technology have the problems of complex operation, difficult positioning, high incidence rate of internal leakage, branch vessel occlusion and the like, the clinical popularization is difficult.
In more detail, 3 branch vessels of the aortic arch of each patient: the physiological structures of the innominate artery, the left common carotid artery and the left subclavian artery are different, and the distances among the openings of the three branch blood vessels, the arrangement angles and the thicknesses of the branch blood vessels are different, so that the shape of the combined bow-shaped blood vessel with the three branches is very different, different bow-shaped blood vessels cannot be completely matched through a prefabricated support, and once the support is not matched with the blood vessels, the intracavity repair treatment cannot be completed. At present, except customizing the support, the clinical problem of rebuilding in order to solve bow blood vessel mainly through bow support windowing technique, chimney technique and single branch support etc. to customizing the support, need customize aorta branch support very much according to patient's concrete anatomical situation, require when implanting aorta pathological change position aorta support blood vessel to aim at the branch artery with its side opening simultaneously, guarantee that branch artery blood flow is unobstructed, implant the little support in the branch artery again, but this kind of method has following shortcoming: the stent is specially customized according to the specific anatomical condition of a patient, the cost is high, the batch production cannot be realized, the time for customizing the stent is long, the stent cannot be used for an emergency operation patient, the operation is complex, each side hole is required to be respectively and accurately aligned to an involved branch artery when the stent is released, if the stent is deviated, the blood flow of the branch artery is possibly obstructed, corresponding complications occur, and the life can be threatened when the stent is serious; the chimney technology ensures the smoothness of the branch blood vessels by arranging a parallel naked stent or a covered stent in the covered branch blood vessels, so that the heart-proximal end opening of the branch blood vessels extends to the front of the aorta covered stent, the proximal anchoring area of the aorta covered stent is prolonged, but internal leakage is easy to generate due to the gap between the branch stent and the main stent; the windowing technology comprises in-vitro windowing and in-vivo in-situ windowing, the original complete straight-cylinder bracket is modified, the operation is complex, the technical requirement on a clinician is high, and certain risks exist; single branch stents can only address reconstruction of one branch at present due to individualized differences in vessels.
All of the above limits the application of the intraluminal interventional procedure to the treatment of type a dissections or aneurysms involving the arch.
Disclosure of Invention
The invention aims to provide an arch part covered stent and a covered stent conveyor to solve the technical problem that the existing covered stent is not beneficial to application of an intracavitary intervention operation on treating an A-type interlayer or aneurysm involving an arch part.
In order to achieve the above purpose, the embodiment of the invention adopts the following technical scheme:
in a first aspect, an embodiment of the present invention provides an arch-shaped covered stent, including a covering membrane and a metal stent;
the covering membrane is connected to the metal stent, and the metal stent is configured to support the covering membrane in a release state so as to enable the covering membrane to be opened to form a cylindrical structure with two open ends in the axial direction;
wherein: the covering film is provided with a window for supplying blood for the bow branch vessel;
the metal bracket comprises a first bracket and a second bracket;
the first stent comprises at least one metal ring, the metal ring is fixedly connected to the covering membrane, and the far end of the first stent is positioned on one side of the near end of the fenestration;
the second stent is in a net cylinder shape with two open ends, the second stent is positioned in the covering membrane and at the far end of the first stent, the second stent covers the windowing in the covering membrane in a release state, the near end of the second stent is connected with the far end of the first stent, and/or the near end of the second stent is connected with the covering membrane, and the above-mentioned 'and/or' means that: the proximal end of the second stent is connected with the distal end of the first stent, or the proximal end of the second stent is connected with the covering membrane, or the proximal end of the second stent is connected with both the distal end of the first stent and the covering membrane;
and a developing part is arranged on the covering film or the second bracket around the window.
With reference to the first aspect, the present embodiments provide a first possible implementation manner of the first aspect, wherein the proximal end of the first stent is located on a distal side of the proximal end of the covering membrane.
With reference to the first aspect, an embodiment of the present invention provides a second possible implementation manner of the first aspect, where the second stent is woven by using a metal wire, or the second stent is engraved by using a laser, or the second stent is formed by sequentially connecting a plurality of metal rings by using a suture.
In combination with the first aspect, embodiments of the present disclosure provide a third possible implementation manner of the first aspect, wherein the arch-shaped stent graft further includes a third stent; the second stent is located between the distal end of the first stent and the proximal end of the third stent; the third stent comprises at least one metal ring, and the metal ring is fixedly connected to the covering membrane.
With reference to the first aspect and one of the first to third possible implementation manners of the first aspect, an embodiment of the present invention provides a fourth possible implementation manner of the first aspect, wherein the metal ring includes at least one wavy metal ring; the wave becket is followed by a plurality of V-arrangement units the circumference of wave becket connects gradually end to end forms, every adjacent two the V-arrangement unit splices each other and is W shape, position fixed connection between the crest and the trough of wave becket in the tectorial membrane.
With reference to the fourth possible implementation manner of the first aspect, the present invention provides a fifth possible implementation manner of the first aspect, wherein part or all of the peaks of the proximal end of the wavy metal ring at or closest to the proximal end of the first stent are not fixed to the covering film.
With reference to the fourth possible implementation manner of the first aspect, the present invention provides a sixth possible implementation manner of the first aspect, wherein a loop coil is connected to each peak of the proximal end of the wavy metal ring closest to the proximal end of the first stent.
With reference to the first aspect and one of the first to third possible embodiments thereof, an embodiment of the present invention provides a seventh possible embodiment of the first aspect, wherein an end coil is connected to a proximal end of the coating film, and the end coil is connected to a radial circumferential surface of the coating film in a released state so as to repeat an operation of passing in from an outer side of the coating film to an inner side of the coating film and passing out from the inner side of the coating film to the outer side of the coating film.
With reference to the first aspect and one of the first to third possible implementation manners of the first aspect, an embodiment of the present invention provides an eighth possible implementation manner of the first aspect, wherein a plurality of traction wires are provided at the distal end of the covering film; and/or a plurality of back ribs extending in the axial direction of the stent are provided at the portion of the stent-graft where the stent-graft is not provided, and in this embodiment, "and/or" means that the structure of "a plurality of traction wires are provided at the distal end of the stent-graft" and the structure of "a plurality of back ribs extending in the axial direction of the stent-graft are provided at the portion of the stent-graft where the stent-graft is not provided" are provided either or both.
In a second aspect, an embodiment of the present invention provides a stent graft conveyer for implanting the arch stent graft provided in the first aspect and one of the possible embodiments thereof into the aorta of a human body, wherein: the tectorial membrane stent conveyor comprises a guide head, a core pipe, a middle pipe, an outer pipe, a flexible membrane sleeve, a middle pipe handle, an outer pipe handle and a pull wire;
the guiding head is sleeved and fixedly connected to the near end of the core tube, the middle tube is sleeved and slidably connected to the outside of the core tube, the flexible membrane sleeve is slidably sleeved on the outside of the middle tube, the outer tube is sleeved on the outside of the flexible membrane sleeve, the outer tube can slide relative to the middle tube, the near end of the pull wire is connected to the far end of the flexible membrane sleeve, the far end of the pull wire extends to the outside of the far end of the outer tube, the handle of the middle tube is connected to the far end of the middle tube, and the handle of the outer tube is connected to the far end of the outer tube;
in a loading state, the arch part covered stent is arranged at the far end of the guide head in a mode of being sleeved outside the middle tube, the second stent is sleeved inside the flexible film sleeve, and the flexible film sleeve is located inside the covered film.
The embodiment of the invention can realize the following beneficial effects:
in a first aspect, an embodiment of the present invention provides an arch-shaped covered stent, including a covering membrane and a metal stent; the covering membrane is connected with the metal support, and the metal support is configured to support the covering membrane in a release state so as to enable the covering membrane to be opened to form a cylindrical structure with two axial ends opened; wherein: the tectorial membrane is provided with a windowing used for supplying blood for the bow branch blood vessel. The metal bracket comprises a first bracket and a second bracket; the first bracket comprises at least one metal ring, the metal ring is fixedly connected to the covering film, and the far end of the first bracket is positioned on one side of the near end of the window; the second stent is in a net cylinder shape with openings at two ends, is positioned in the covering film and at the far end of the first stent, and covers the fenestration in the covering film in a release state; the proximal end of the second stent is connected with the distal end of the first stent and/or the proximal end of the second stent is connected with the covering membrane; and a developing part is arranged on the covering film or the second bracket around the opening window.
In the embodiment of the invention, when the device is used, the developing part is used as a developing mark, the whole bow covered stent is pushed to a lesion position through the femoral artery by using the covered stent conveyor, and the covered stent conveyor is operated to release the bow covered stent, so that the fenestration part is aligned to the junction of the branch blood vessel and the aorta; in the process, the covering film is released before the second stent, the near end of the first stent is released finally, the covering film is attached to the wall in advance under the action of blood flow impact after being released to adapt to the shape of the blood vessel, the windowing part of the covering film is supported after the second stent is opened, so that the covering film is attached to the wall well, the supporting force of the windowing part is improved, the problem that the covering film at the windowing part is deformed and leaks due to the later blood flow impact is avoided, the sealing property of the covering film at the windowing part is improved, and the morbidity risk of postoperative complications is reduced; meanwhile, the second support is in a net cylinder shape with openings at two ends, has higher flexibility, and solves the problems of poor flexibility and stack of the blood vessel cloth caused by the interaction of the coating and the metal support.
The arch part covered stent provided by the embodiment has the advantages of simple structure, convenience for implantation, no need of treating the branch blood vessel of the arch part, simplicity and convenience for operation, and is particularly suitable for the interlayer/aneurysm with the lacerated opening positioned at the minor bend side, the blood supply of the aorta and the branch artery thereof can be reconstructed in the shortest possible time, and the technical problem that the existing covered stent is not beneficial to the application of an intracavity interventional operation on the A-type interlayer or aneurysm of the affected arch part is solved. In this embodiment, the specific shape of the open window may be, but is not limited to, an ellipse, a rounded rectangle, an arc, and the like, and is not limited herein.
In addition, a second aspect of the embodiment of the invention also provides a covered stent conveyor, which is used for implanting the arch covered stent provided by the first aspect into the aorta vessel of a human body; the specific use mode is shown in a specific embodiment.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a schematic overall structural view of a first alternative embodiment of an arcuate stent graft provided by an embodiment of the present invention;
FIG. 2 is a schematic overall structural view of a second alternative embodiment of an arch stent graft according to an embodiment of the present invention;
FIG. 3 is a schematic view of the overall structure of a second stent of the arch stent graft according to the embodiment of the present invention;
FIG. 4 is a schematic structural view of the proximal undulating metal ring of the first stent in a free state in an arcuate stent graft according to an embodiment of the present invention;
FIG. 5 is a schematic view of a proximal end of a stent graft having a loop coil in a released state according to an embodiment of the present invention;
FIG. 6 is a schematic view of a proximal end structure of a stent graft with an end coil in a released state of an arched stent graft according to an embodiment of the present invention;
FIG. 7 is a side view of a proximal structure of a stent graft with an end coil in a released state of an arcuate stent graft according to an embodiment of the present invention;
FIG. 8 is a side view of a proximal structure of a stent graft with an end coil in a compressed state according to an embodiment of the present invention;
FIG. 9 is a state diagram of the stent graft transporter according to the present embodiment delivering the arch-shaped stent graft according to the present embodiment to the aortic vessel without releasing the arch-shaped stent graft;
FIG. 10 is a state diagram of the stent graft transporter provided in accordance with an embodiment of the present invention initially releasing a second stent;
FIG. 11 is a state diagram of the stent graft transporter provided in accordance with the present invention further releasing the second stent but not completely releasing the second stent;
FIG. 12 is a schematic structural view of the aortic vessel fitted with an arch stent graft after the stent graft delivery apparatus according to the embodiment of the present invention completely releases the arch stent graft.
Icon: 1-covering a film; 10-windowing; 11-a toroidal coil; 12-an end coil; 21-a first scaffold; 22-a second support; 23-a third scaffold; 3-a developing section; 41-a guide head; 42-core tube; 43-an outer tube; 44-a flexible membrane sleeve; 45-intermediate pipe; 46-guide wire.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
In the description of the present invention, it should be noted that the terms "far", "near", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or orientations or positional relationships conventionally put on when products of the present invention are used, and are only used for convenience of description and simplification of description, but do not indicate or imply that the devices or elements referred to must have specific orientations, be constructed in specific orientations, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.
In particular, the term "proximal" refers to the end closer to the heart and "distal" refers to the end further away from the heart.
In addition, in the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.
Example one
The present embodiment provides an arch stent graft, which, referring to fig. 1, 3 and 4, includes a stent graft 1 and a metal stent; the covering membrane 1 is connected to a metal stent, and the metal stent is configured to support the covering membrane 1 in a release state so that the covering membrane 1 is opened to form a cylindrical structure with two open ends in the axial direction; wherein: the covering film 1 is provided with a fenestration 10 for supplying blood to the branch vessel of the arch part. The metal bracket includes a first bracket 21 and a second bracket 22; the first stent 21 comprises at least one metal ring which is fixedly connected with the tectorial membrane 1, and the far end of the first stent 21 is positioned at one side of the near end of the fenestration 10; the second stent 22 is in a net cylinder shape with two open ends, the second stent 22 is positioned in the tectorial membrane 1 and at the far end of the first stent 21, and the second stent 22 covers the fenestration 10 in the tectorial membrane 1 under the release state; the proximal end of the second stent 22 is attached to the distal end of the first stent 21, and/or the proximal end of the second stent 22 is attached to the cover 1, the foregoing "and/or" indicating: the proximal end of the second stent 22 is attached to the distal end of the first stent 21, or the proximal end of the second stent 22 is attached to the stent graft 1, or the proximal end of the second stent is attached to both the distal end of the first stent 21 and the stent graft 1. The developing part 3 is arranged on the covering film 1 or the second support 22 around the opening window 10, the developing part 3 can be but not limited to developing markers such as gold wires, annular developing markers can be arranged around the opening window 10, or a plurality of developing markers can be arranged around the opening window 10 in a pairwise spaced mode, as long as the developing effect can be achieved.
In the embodiment, when the device is used, the developing part 3 is used as a developing mark, the covered stent conveyor is utilized to push the whole bow covered stent to the lesion position through the femoral artery, and the covered stent conveyor is operated to release the bow covered stent, so that the fenestration 10 part is aligned to the intersection of the branch blood vessel and the aorta; in the process, the covering film 1 is released before the second support 22, the near end of the first support 21 is released finally, the covering film 1 is attached to the wall in advance under the action of blood flow impact to adapt to the shape of the blood vessel after being released, the second support 22 supports the windowing 10 part of the covering film 1 after being opened, so that the covering film is attached to the wall well, the supporting force of the windowing 10 part is improved, the problem that the covering film 1 at the windowing 10 part is deformed and leaked due to the blood flow impact in the later period is avoided, the sealing performance of the covering film 1 at the windowing 10 part is improved, and the morbidity risk of postoperative complications is reduced; meanwhile, the second stent 22 is in a net cylinder shape with openings at two ends, has higher flexibility, and relieves the problems of poor flexibility and blood vessel cloth stacking caused by the interaction of the film 1 and the metal stent.
The arch part covered stent provided by the embodiment has the advantages of simple structure, convenience for implantation, no need of treating the branch blood vessel of the arch part, simplicity and convenience for operation, and is particularly suitable for the interlayer/aneurysm with the lacerated opening positioned at the minor bend side, the blood supply of the aorta and the branch artery thereof can be reconstructed in the shortest possible time, and the technical problem that the existing covered stent is not beneficial to the application of an intracavity interventional operation on the A-type interlayer or aneurysm of the affected arch part is solved. In this embodiment, the specific shape of the open window 10 may be, but is not limited to, an ellipse, a rounded rectangle, an arc, etc., and is not limited herein.
With continued reference to FIG. 1, in an alternative embodiment of this embodiment, it is preferable that the proximal end of the first stent 21 is located distally of the proximal end of the stent graft 1, so that the proximal end of the arch stent graft is free from bare stent, which can avoid the proximal end of the first stent 21 from stimulating the vessel wall to form a new laceration during the operation, thereby further reducing the negative risk of the operation. The distal end of the second stent 22 may be located inside the distal end of the stent graft 1 or may extend outside the distal end of the stent graft 1, and it is preferable that the distal end of the second stent 22 is located inside the distal end of the stent graft 1.
In this embodiment, the second stent 22 has a specific structure as shown in fig. 3, and the second stent 22 has a molded structure such as, but not limited to, a woven metal wire for the second stent 22, or a laser engraved metal wire for the second stent 22, or a plurality of metal rings sequentially connected by stitches for the second stent 22.
Referring to FIG. 2, in an alternative embodiment of the present embodiment, the arch stent graft preferably further comprises a third stent 23; specifically, the second stent 22 is located between the distal end of the first stent 21 and the proximal end of the third stent 23; the third stent 23 comprises at least one metal ring which is fixedly connected to the cover 1. In this embodiment, by providing the third stent 23, the adherence property of the stent graft 1 in the open state can be further improved, and further the risk of inner leakage can be further avoided, and further preferably, the distal end of the third stent 23 is located at the proximal end side of the distal end of the stent graft 1, so that the distal end of the arch stent graft has no bare stent, and the distal end of the third stent 23 can be prevented from stimulating a vascular wall to form a new rupture during the operation, and further the negative risk of the operation can be reduced.
Referring to fig. 1-4, the specific structure of the metal ring mentioned in the above-mentioned several alternative embodiments of the present embodiment preferably includes at least one wavy metal ring; as shown in fig. 1, 2 and 4, the wavy metal ring is formed by sequentially connecting a plurality of V-shaped units end to end along the circumferential direction of the wavy metal ring, every two adjacent V-shaped units are spliced to form a W shape, and the parts between the wave crests and the wave troughs of the wavy metal ring are fixedly connected to the coating film 1. Further, in this embodiment, the metal rings included in each of the first support 21 and the third support 23 may be all the wavy metal rings, or some of the metal rings may be ordinary metal rings, and the rest of the metal rings are the wavy metal rings with the above structure. In the case of the first stent 21, it is preferable that, as shown in fig. 4, a part or all of the proximal peaks of the undulating metallic ring at or closest to the proximal end of the first stent 21 are not fixed to the stent graft 1, that is, a part or all of the proximal peaks of the undulating metallic ring at or closest to the proximal end of the first stent 21 are in a free state.
To cooperate with the stent graft conveyor to retract or release the proximal end of the first stent 21 of the arcuate stent graft, in some alternative embodiments of the present embodiment, as shown in FIG. 5, a loop coil 11 is attached to each peak of the proximal end of the undulating metallic ring closest to the proximal end of the first stent 21. In some optional embodiments of the present embodiment, as shown in fig. 6 to 8, an end coil 12 is connected to the proximal end of the coating 1, and the end coil 12 is connected to the radially circumferential surface of the coating 1 in the released state so as to repeat the operation of passing in from the outside of the coating 1 to the inside of the coating 1 and then out from the inside of the coating 1 to the outside of the coating 1.
In addition, in order to make the fenestrated 10 site of the second stent 22 release the front covering film 1 sufficiently align with the brachiocephalic vessel, in an optional embodiment of the present embodiment, it is preferable that a plurality of pulling wires (not shown in the drawings) are provided at the distal end of the covering film 1 to pull the covering film 1 through the pulling wires, and the specific arrangement manner of the pulling wires provided at the distal end of the covering film 1 includes, but is not limited to, passing the pulling wires through the covering film 1, both ends of the pulling wires are used for pulling the covering film 1 to pull the covering film 1, and finally, one end of the pulling wires can be pulled to separate the pulling wires from the covering film 1 and withdraw the pulling wires to the outside of; and/or, a plurality of back ribs (not shown in the figure) extending along the axial direction of the covering membrane 1 are arranged at the position of the covering membrane 1 without the metal stent, so as to assist the covering membrane 1 to be capable of carrying out fine adjustment in the axial direction and the circumferential direction before the second stent 22 is released, in the embodiment, the expression "and/or" indicates that the structure of "a plurality of traction lines are arranged at the far end of the covering membrane 1" and the structure of "a plurality of back ribs extending along the axial direction of the covering membrane 1 are arranged at the position of the covering membrane 1 without the metal stent" are alternatively or simultaneously arranged.
Example two
The present embodiment provides a stent graft transporter for implanting the arch stent graft provided in the first embodiment into the aortic blood vessel of a human body, wherein, referring to fig. 9 to 12, the stent graft transporter comprises a guide head 41, a core tube 42, an intermediate tube 45, an outer tube 43, a flexible membrane sleeve 44, an intermediate tube handle, an outer tube handle and a pull wire; the guide head 41 is sleeved and fixedly connected with the proximal end of the core tube 42, the middle tube 45 is sleeved and slidably connected with the outside of the core tube 42, the flexible membrane sleeve 44 is slidably sleeved on the outside of the middle tube 45, the outer tube 43 is sleeved on the outside of the flexible membrane sleeve 44, the outer tube 43 can slide relative to the middle tube 45, the proximal end of the pull wire is connected with the distal end of the flexible membrane sleeve 44, the distal end of the pull wire extends to the outside of the distal end of the outer tube 43, the middle tube handle is connected with the distal end of the middle tube 45, and the outer tube handle is connected with the distal. In the loaded state, the arch stent graft is mounted on the distal end of the guide head 41 so as to be fitted around the outside of the core tube 42, the second stent 22 is fitted inside the flexible sheath 44, and the flexible sheath 44 is positioned inside the stent graft 1.
The specific process of implanting the arch part covered stent into the aortic artery of the human body by using the covered stent conveyor is as follows:
firstly, loading the arch part covered stent into a covered stent conveyor according to the loading mode, and then implanting a guide wire 46 according to the sequence of fig. 9 to fig. 12 in the first step; secondly, inserting the distal end of a guide wire 46 into the guide head 41 and penetrating through the core tube 42, so that the covered stent conveyor is conveyed to a lesion part under the guidance of the guide wire 46; thirdly, under the guidance of a guide wire 46, the front end of the covered stent conveyor is pushed to an expected release position, a middle tube handle is fixed, an outer tube handle is withdrawn, an outer tube 43 is withdrawn later, the first stent 21 is partially released, at the moment, the far end of the covered stent 1 is unfolded under the action of blood flow impact, the second stent 22 is still in a state of being compressed in a flexible film sleeve 44, and then the position of the covered stent 1 is finely adjusted in a traction mode, so that the fenestration 10 is aligned to the junction of the aorta and the branch vessel as accurately as possible; then pulling the pull wire connected to the flexible film sleeve 44 backwards to enable the flexible film sleeve 44 to release the second stent 22, and the far end of the tectorial membrane 1 is fully attached to the wall under the supporting action of the second stent 22; finally, the handle of the middle tube is withdrawn, the near end of the first stent 21 is released, and then the whole covered stent conveyor and the guide wire 46 are both withdrawn from the body, namely the work of implanting the arch covered stent into the aortic artery of the human body is completed.
Finally, it should be noted that: the embodiments in the present description are all described in a progressive manner, each embodiment focuses on the differences from the other embodiments, and the same and similar parts among the embodiments can be referred to each other; the above embodiments in the present specification are only used for illustrating the technical solutions of the present invention, and not for limiting the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims (10)

1. The arch part film-coated bracket is characterized by comprising a film (1) and a metal bracket;
the film (1) is connected to the metal support, and the metal support is configured to support the film (1) in a release state, so that the film (1) is opened to form a cylindrical structure with two open ends in the axial direction; wherein:
the covering film (1) is provided with a windowing (10) for supplying blood for the bow branch vessel;
the metal bracket comprises a first bracket (21) and a second bracket (22);
the first bracket (21) comprises at least one metal ring which is fixedly connected with the covering film (1), and the far end of the first bracket (21) is positioned on one side of the near end of the windowing (10);
the second support (22) is in a net cylinder shape with two open ends, the second support (22) is positioned inside the covering film (1) and at the far end of the first support (21), and the second support (22) covers the windowing (10) inside the covering film (1) in a release state; the proximal end of the second stent (22) is connected to the distal end of the first stent (21), and/or the proximal end of the second stent (22) is connected to the cover (1);
a developing part (3) is arranged on the position surrounding the windowing (10) on the coating film (1) or the second bracket (22).
2. The arch stent graft of claim 1, wherein the proximal end of the first stent (21) is distal to the proximal end of the stent graft (1).
3. The arch stent graft of claim 1, wherein the second stent (22) is woven from wire, or wherein the second stent (22) is laser engraved, or wherein the second stent (22) is formed from a plurality of metal rings that are sequentially joined by sutures.
4. The arch stent graft of claim 1, wherein the arch stent graft further comprises a third stent (23);
the second stent (22) is located between the distal end of the first stent (21) and the proximal end of the third stent (23); the third support (23) comprises at least one metal ring which is fixedly connected to the membrane (1).
5. The arch-stent of any one of claims 1-4, wherein the metal ring comprises at least one undulating metal ring;
the wavy metal ring is formed by sequentially connecting a plurality of V-shaped units along the circumferential direction of the wavy metal ring end to end, every two adjacent V-shaped units are spliced with each other to form a W shape, and the positions between the wave crests and the wave troughs of the wavy metal ring are fixedly connected with the coating (1).
6. The arch stent graft of claim 5, wherein some or all of the proximal peaks of the undulating metal ring at or closest to the proximal end of the first stent (21) are not fixed to the stent graft (1).
7. The arch stent graft of claim 5, wherein an annular coil (11) is attached to each peak of the proximal end of the undulating metal ring closest to the proximal end of the first stent (21).
8. Bow stent graft according to any one of claims 1 to 4, wherein an end coil (12) is connected to the proximal end of the stent graft (1), the end coil (12) being connected to the radially circumferential surface of the stent graft (1) in the released state in such a way that the passing in from the outside of the stent graft (1) to the inside of the stent graft (1) and the passing out from the inside of the stent graft (1) to the outside of the stent graft (1) is repeated.
9. The arch-type stent graft of any one of claims 1-4, wherein a plurality of pull wires are provided at the distal end of the stent graft (1); and/or a plurality of back ribs extending along the axial direction of the coating film (1) are arranged at the position without the metal bracket on the coating film (1).
10. A stent graft transporter for implanting the arch stent graft of any one of claims 1 to 9 into an aortic blood vessel of a human body,
the tectorial membrane stent conveyor comprises a guide head (41), a core tube (42), a middle tube (45), an outer tube (43), a flexible membrane sleeve (44), a handle of the middle tube, a handle of the outer tube and a pull wire;
the guide head (41) is sleeved and fixedly connected to the proximal end of the core tube (42), the middle tube (45) is sleeved and slidably connected to the outside of the core tube (42), the flexible membrane sleeve (44) is slidably sleeved on the outside of the middle tube (45), the outer tube (43) is sleeved on the outside of the flexible membrane sleeve (44), the outer tube (43) can slide relative to the middle tube (45), the proximal end of the pull wire is connected to the distal end of the flexible membrane sleeve (44), the distal end of the pull wire extends to the outside of the distal end of the outer tube (43), the middle tube handle is connected to the distal end of the middle tube (45), and the outer tube handle is connected to the distal end of the outer tube (43);
in a loading state, the arch tectorial membrane stent is arranged at the far end of the guide head (41) in a mode of being sleeved outside the middle tube (45), the second stent (22) is sleeved inside the flexible membrane sleeve (44), and the flexible membrane sleeve (44) is positioned inside the tectorial membrane (1).
CN202110336916.4A 2021-03-29 2021-03-29 Bow part tectorial membrane support and tectorial membrane support conveyer Active CN112842619B (en)

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CN115363835A (en) * 2022-10-27 2022-11-22 北京华脉泰科医疗器械股份有限公司 Conveyor and conveyor handle for conveying stacked covered stents
CN115381610A (en) * 2022-10-27 2022-11-25 北京华脉泰科医疗器械股份有限公司 Release method of covered stent and high-flexibility covered stent
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CN118217045A (en) * 2024-05-22 2024-06-21 北京心祐医疗科技有限公司 Tectorial membrane support, tectorial membrane support conveyer and tectorial membrane support conveying system

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CN105832447A (en) * 2016-05-27 2016-08-10 杨威 Covered stent for aortic dissection surgery, delivery device and use method thereof
CN214857826U (en) * 2021-03-29 2021-11-26 北京华脉泰科医疗器械股份有限公司 Bow covered stent and covered stent conveyor

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Publication number Priority date Publication date Assignee Title
CN105832447A (en) * 2016-05-27 2016-08-10 杨威 Covered stent for aortic dissection surgery, delivery device and use method thereof
CN214857826U (en) * 2021-03-29 2021-11-26 北京华脉泰科医疗器械股份有限公司 Bow covered stent and covered stent conveyor

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023125547A1 (en) * 2021-12-30 2023-07-06 先健科技(深圳)有限公司 Covered stent
CN115363835A (en) * 2022-10-27 2022-11-22 北京华脉泰科医疗器械股份有限公司 Conveyor and conveyor handle for conveying stacked covered stents
CN115381610A (en) * 2022-10-27 2022-11-25 北京华脉泰科医疗器械股份有限公司 Release method of covered stent and high-flexibility covered stent
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CN115363835B (en) * 2022-10-27 2023-01-31 北京华脉泰科医疗器械股份有限公司 Conveyor for conveying stacked covered stents
CN118217045A (en) * 2024-05-22 2024-06-21 北京心祐医疗科技有限公司 Tectorial membrane support, tectorial membrane support conveyer and tectorial membrane support conveying system

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