WO2022041903A1 - Stent device and stent system - Google Patents

Stent device and stent system Download PDF

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Publication number
WO2022041903A1
WO2022041903A1 PCT/CN2021/097490 CN2021097490W WO2022041903A1 WO 2022041903 A1 WO2022041903 A1 WO 2022041903A1 CN 2021097490 W CN2021097490 W CN 2021097490W WO 2022041903 A1 WO2022041903 A1 WO 2022041903A1
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WO
WIPO (PCT)
Prior art keywords
stent
guide wire
pulling
control guide
window
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PCT/CN2021/097490
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French (fr)
Chinese (zh)
Inventor
赵明杰
朱永锋
彭大冬
朱清
赵淑华
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
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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
Publication of WO2022041903A1 publication Critical patent/WO2022041903A1/en

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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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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

Definitions

  • the invention relates to the technical field of medical devices, in particular to a stent device and a stent system.
  • Stent graft fenestration technology is generally used in the treatment of diseases involving bifurcated vessels, and it has the advantages of isolating diseased vessels and maintaining the blood flow of bifurcated vessels.
  • a branch stent is generally installed at the window. If the alignment of the window and the bifurcated blood vessel is not accurate, it will also cause difficulty in establishing a branch stent guide wire path, or even impossible to establish a branch stent guide wire path.
  • the purpose of the present invention is to provide a stent device and a stent system, which can effectively avoid the occlusion of branch blood vessels caused by the inaccurate position of the stent after the stent is released.
  • the present invention provides a bracket device, comprising a bracket and a control mechanism, wherein,
  • the control mechanism comprises a control guide wire and a pulling part arranged on the control guide wire, the control guide wire is arranged along the axial direction of the stent and is used to be movably arranged on the inner wall of the stent;
  • the bracket is provided with a window, a connecting part and a limiting part; the connecting part is arranged on the side of the bracket where the window is provided, and is used for connecting with the pulling part; the limiting part is used for restricting the position of the control guide wire in the circumferential and radial directions of the stent;
  • the stent device is configured such that when the pulling portion is connected to the connecting portion and the stent is in an expanded state, the control guide wire applies a pulling force to the connecting portion through the pulling portion, so as to cause the stent to be pulled.
  • the stent wall around the window is recessed towards the lumen of the stent.
  • the connecting portion includes a first coil, and the proximal end of the pulling portion is connected to a connecting point on the control guide wire;
  • the pulling portion passes through the first coil and the distal end of the pulling portion is sheathed on the distal side of the control guide wire at the connection point;
  • the stent device is configured such that when the control guide wire is moved in the axial direction of the stent toward the proximal end of the stent, the distal end of the pulling portion is disengaged from the control guide wire and removed from the first end of the stent. A coil is passed through to release the connection between the pulling part and the connecting part.
  • the pulling part comprises a pulling rope and a second coil, the proximal end of the pulling rope is connected with the control guide wire, and the distal end of the pulling rope is connected with the second coil;
  • the pulling rope is used to pass through the first coil, and the second coil is used to be sleeved on the control guide wire.
  • the pulling portion includes a pulling rope in an annular structure.
  • the number of the connecting portion is one, and the length of the pulling portion is greater than the distance from the connecting point to the distal end of the control guide wire, and is less than the stent in a natural expansion state. twice the diameter at the window.
  • the limiting portion includes at least two sub-limiting portions, and the at least two sub-limiting portions are arranged at intervals along the axial direction of the stent; the distal end of the pulling portion is sleeved on the control on the guide wire and located between two adjacent sub-limiting parts.
  • the sub-limiting portion includes a third coil, and the control guide wire is used to movably pass through the third coil.
  • At least two of the sub-limiting portions are arranged on both axial sides of the connecting portion.
  • the bracket has a radially opposite first side and a second side, the first side is provided with the window, and the second side is provided with the limiting portion.
  • the stent includes a stent body and a coating covering the stent body, and both the connecting portion and the limiting portion are sewn on the stent body.
  • the present invention also provides a stent system, comprising a delivery device and the stent device according to any one of the preceding items, the delivery device is used to deliver the stent device to a predetermined position.
  • the stent device and stent system of the present invention have the following advantages:
  • the aforementioned stent device includes a stent and a control mechanism, wherein the control mechanism includes a control guide wire and a pulling portion provided on the control guide wire, and the control guide wire is arranged along the axial direction of the stent, and is used to be movably arranged on the inner wall of the bracket; the bracket is provided with a window, a connecting part and a limiting part, and the connecting part is arranged on the side of the bracket with the window and is used for connecting with all the brackets.
  • the pulling part is connected; the limiting part is used to limit the position of the control guide wire in the circumferential and radial directions of the stent.
  • the stent device is configured such that when the pulling portion is connected to the connecting portion and the stent is in an expanded state, the control guide wire applies a pulling force to the connecting portion through the pulling portion, so as to cause the stent to be pulled.
  • the stent wall around the window is recessed towards the lumen of the stent.
  • the stent is delivered to the intravascular lesion site and then released, and the stent wall around the window is concave toward the stent lumen and away from the blood vessel wall under the pulling action of the control mechanism, so as to ensure that the branch blood vessel is not blocked, neither. It will cause branch vessel ischemia, and will not adversely affect the construction of the guide wire pathway of the branch stent at the window.
  • the connecting portion includes a first coil, and the proximal end of the pulling portion is connected to a connection point on the control guide wire; the pulling portion passes through the first coil and the pulling portion
  • the distal end of the control guide wire is connected to the distal end side of the control guide wire at the connection point, so as to realize the connection of the pulling part and the connecting part;
  • the stent device is configured to be used when the control guide wire is When moving toward the proximal end of the stent along the axial direction of the stent, the distal end of the pulling part is separated from the control guide wire and passes through the first coil, so as to release the pulling part from the other end. the connection of the connecting part.
  • the connection between the pulling part and the connecting part can be released, so that the stent wall near the window is attached to the blood vessel wall, and the operation is simple and convenient.
  • FIG. 1 is a schematic structural diagram of a stent device according to an embodiment of the present invention.
  • FIG. 2 is a schematic structural diagram of a control mechanism of a stent device provided by the present invention according to an embodiment
  • FIG. 3 is a schematic structural diagram of a control mechanism of a stent device provided by another embodiment of the present invention.
  • FIG. 4 is a schematic structural diagram of a stent of a stent device according to an embodiment of the present invention.
  • FIG. 5 is a schematic diagram of the stent device according to an embodiment of the present invention when the stent device is implanted into the aortic arch.
  • 100-control mechanism 110-control guide wire; 120-pulling part; 121-pulling rope, 122-second coil; 200-support; 201-window; 210-connecting part; 221-sub-limiting part.
  • each embodiment of the following description has one or more technical features, but this does not mean that the person using the present invention must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately.
  • One or all of the technical features of the .
  • those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or The combination of some or all of the technical features in the multiple embodiments is selectively implemented, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a,” “an,” and “the” include plural referents, and the plural forms “a plurality” include two or more referents unless the content clearly dictates otherwise.
  • the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise, and the terms “installed”, “connected”, “connected” shall be To be understood in a broad sense, for example, it may 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 the internal communication between two elements or the interaction relationship between the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.
  • proximal distal
  • distal is the relative orientation, relative position, orientation of elements or actions relative to each other from the perspective of the physician using the medical device, although “proximal”, “distal” “ is not limiting, but “proximal” generally refers to the end of the medical device that is closest to the physician during normal operation, and “distal” generally refers to the end that first enters the patient.
  • the core idea of the present invention is to provide a stent device, which is mainly used for the treatment of lesions at bifurcated vessels, such as lesions at the aortic arch involving branch arteries.
  • the stand device includes a stand and a control mechanism.
  • the control mechanism includes a control guide wire and a pulling part arranged on the control guide wire.
  • the control guide wire is arranged along the axial direction of the stent and can be movably arranged on the inner wall of the stent.
  • the bracket is provided with a window, a connecting part and a limiting part, the connecting part is arranged on the side of the bracket where the window is provided, and is used for connecting with the pulling part; the limiting part is used for limiting The position of the control guide wire in the circumferential and radial directions of the stent.
  • the stent is configured such that when the pulling part is connected to the connecting part and the stent is in an expanded state, the control guide wire applies a pulling force to the connecting part through the pulling part, so that the The bracket wall around the window is recessed toward the inner cavity of the bracket.
  • the connecting portion around the window is pulled by the control mechanism, so that the stent wall around the window is away from the blood vessel wall, so that there is a gap between the two, and blood flow can be prevented.
  • the branch blood vessels flow into this gap, so as to avoid the occlusion of the branch blood vessels due to inaccurate alignment of the window and the branch stent.
  • the window is also provided with a branch stent, since there is a gap between the stent wall and the blood vessel wall around the window, even if the window and the branch blood vessel are not accurately aligned, the construction of the control guide wire channel of the branch stent will not be adversely affected. .
  • the connecting portion includes a first coil, and the proximal end of the pulling portion is connected to a connection point on the control guide wire; the pulling portion passes through the first coil and is The distal end of the pulling portion is sleeved on the distal side of the control guide wire at the connection point, and then positioned to the point where the control guide wire is positioned at the connection point between the pulling portion and the control guide wire.
  • the connection between the pulling part and the connecting part is realized; the stent device is configured such that when the control guide wire moves toward the proximal end of the stent along the axial direction of the stent, the stent device The distal end of the pulling part is separated from the control guide wire and passes through the first coil to release the connection between the pulling part and the connecting part. That is to say, after the operator completes the posture adjustment of the stent and the construction of the guide wire passage of the branch blood vessel (when the branch stent needs to be installed), the connection between the pulling part and the connecting part can be released by withdrawing the control guide wire. , so that the stent wall adjacent to the window is attached to the blood vessel wall, and the operation is simple and convenient.
  • FIG. 1 shows a schematic structural diagram of a stent device provided by a preferred embodiment of the present invention
  • FIG. 2 and FIG. 3 respectively show structural schematic diagrams of two optional control mechanisms of the stent device
  • FIG. 4 shows a stent of the stent device. Schematic diagram of the structure.
  • the bracket device includes a control mechanism 100 and a bracket 200 .
  • the control mechanism 100 includes a control guide wire 110 and a pulling portion 120 disposed on the control guide wire 110
  • the control guide wire 110 is arranged along the axial direction of the stent 200, and can move movably arranged on the inner wall of the bracket 200 .
  • the stent 200 is usually a stent-graft, and a window 201 that communicates with the inner cavity of the stent is provided on the stent 200 , and a connecting portion 210 and a limiting portion are also provided on the stent 200 .
  • the connecting portion 210 is disposed on the side of the bracket 200 where the window 201 is provided, and is used for connecting with the pulling portion 120 .
  • the limiting portion is used to limit the position of the control guide wire 110 in the circumferential and radial directions of the stent 200 .
  • the stent device is configured such that when the pulling portion 120 is connected to the connecting portion 210 and the stent 200 is in an expanded state, the control guide wire 110 passes through the pulling portion 120 to the connecting portion. 210 exerts a pulling force so that the stent wall around the window 201 is recessed toward the lumen of the stent 200 .
  • the connecting portion 210 is arranged at the periphery of the window 201.
  • the connecting portion 210 is arranged at the edge of the window 201. In other embodiments, the The connecting portion 210 and the edge of the window 201 have a predetermined distance, and the predetermined distance is determined according to the actual situation. As long as the control guide wire 110 exerts a pulling force on the connecting portion 210 through the pulling portion, all the The bracket wall around the window 201 may be recessed.
  • FIG. 5 shows a schematic diagram of the stent device applied to aortic arch lesions involving branch vessels.
  • the side of the stent 200 provided with the window 201 is disposed toward the greater curvature of the aortic arch.
  • one of the windows 201 should be aligned with one of the branch arteries, so that blood flow can flow into the branch arteries from the window 201 .
  • the alignment of the window 201 and the branch artery is often inaccurate due to various reasons, and the branch blood vessel is blocked.
  • the control mechanism 100 of the stent device provided in this embodiment pulls the stent through the pulling part 120
  • the connecting part 210 on the 200 makes the stent wall around the window 201 recess toward the lumen of the stent 200 to form a gap with the blood vessel wall, so that blood flow can flow into the gap from the window 201 , and then flow into branch vessels to avoid branch vessel ischemia.
  • the existence of the gap also makes the construction of the branch blood vessel guide wire easier.
  • the stent 200 includes a stent body and a covering film disposed on the stent body, and both the connecting portion 210 and the limiting portion are sewn on the stent body of the stent 200 .
  • the connecting portion 210 and the limiting portion may also be sewn on the covering film, which is determined according to actual conditions.
  • the bracket 200 has a first side and a second side diametrically opposite, and the window 201 is disposed on the first side (that is, the first side is on the first side).
  • the first side is the side adjacent to the branched vessel
  • the connecting portion 210 is also arranged on the first side and the limiting portion is preferably arranged on the second side, so that the control guide wire 110 is movably arranged on the inner wall of the second side of the bracket 200 .
  • the advantage of this arrangement is that when the stent 200 is in the expanded state, the pulling force exerted by the control guide wire 110 on the connecting portion 210 is maximized, ensuring that the stent wall adjacent to the window 201 can reach the stent 200 cavity depression.
  • the pulling portion 120 is a flexible elongated structure, and the proximal end thereof can be connected to the connection point on the control guide wire 110 by hot melting, gluing or other suitable methods.
  • the connection part 210 includes at least one first coil. The pulling part is passed through the first coil, and the distal end of the pulling part is sheathed on the distal side of the control guide wire located at the connection point, so as to realize the pulling The connection between the part 120 and the connection part 210 .
  • the stent device is configured such that when the control guide wire 110 moves toward the proximal end of the stent 200 along the axial direction of the stent 200 , the distal end of the pulling portion 120 is disengaged from the control guide wire 110 .
  • the distal end of the pulling portion 120 can be connected to the distal end of the control guide wire at the connection point after passing through the first coil from the proximal end side of the first coil.
  • the connection between the pulling part 120 and the connecting part 210 is realized.
  • the control guide wire 110 moves toward the proximal end of the stent 200 along the axial direction of the stent 200 , so that the The distal end is separated from the control guide wire 110 and passed through the first coil from the distal end side of the first coil.
  • This structure makes it convenient for the operator to remove the control mechanism 100 from the stent 200 by withdrawing the control guide wire 110 to the outside of the body after completing the construction of the guide wire path of the branch stent.
  • the pulling force exerted by the control guide wire 110 on the stent wall around the window 201 through the connecting portion 210 is released, so that the stent wall around the window 201 is in close contact with the blood vessel wall to block the lesion.
  • proximal side of the first coil refers to that when the posture of the first coil is adjusted so that the plane where the first coil is located is perpendicular to the axis of the stent 200, the The side of the first coil facing the proximal end of the stent 200, and the side of the first coil facing the distal end of the stent 200 in this posture is the “distal side of the first coil” ".
  • the present invention does not limit the number of the first coils, which may also be two, three or more.
  • the pulling portion passes through at least one of the first coils and then communicates with the control conductor. wire connection.
  • the pulling part 120 includes a pulling cord 121 and a second coil 122 disposed at the distal end of the pulling cord 121 .
  • the limiting portion is disposed on the inner wall of the bracket 200 and includes at least two sub-limiting portions 221 , and the at least two sub-limiting portions 221 are along the axial direction of the bracket 200 . Arranged at intervals, for example, at least two of the sub-limiting portions 221 are distributed on both axial sides of the connecting portion 210 .
  • each of the sub-limiting portions 221 may include a third coil, and the control guide wire 110 is disposed on the inner wall of the second side of the stent 200 when the control guide wire 110 is passed through the third coil. .
  • the limiting portion may include two sub-limiting portions 211 .
  • the distal end of the pulling portion 120 is sleeved on the portion of the control guide wire 110 located between the two adjacent sub-limiting portions 221, which is Because this part of the control wire 110 is restricted by the two sub-limiting parts 211 , it will not move towards the window 201 due to the reaction force of the connecting part 210 when the stent 200 is expanded, so that Ensure that the connecting portion 210 is effectively pulled.
  • the assembled stent device can be loaded into a delivery system after the stent 200 is crimped and delivered to the diseased blood vessel.
  • the control mechanism 100 pulls the connecting portion 210 to form a gap between the stent wall around the window 201 and the blood vessel wall.
  • the operator pulls back the proximal end of the control guide wire 110 to withdraw the control guide wire 110 from the body.
  • the distal end of the control guide wire 110 passes through the two sub-limiting parts 221 in sequence, and at the same time, after the pulling part 120 is separated from the control guide wire 110 , it passes through the connecting part 210 again.
  • the connection between the pulling portion 120 and the connecting portion 210 is released, and at this time, the stent wall near the window 201 is attached to the blood vessel wall.
  • the connecting portion 210 , the sub-limiting portion 211 and the pulling portion 120 are all made of wires, which are soft and easy to bend, and will not adversely affect the pressing and holding of the bracket 200 , nor will it The stent 200 is damaged.
  • the connecting portion 210 , the sub-limiting portion 221 and the distal end of the pulling portion 120 are all designed as coils, which have the advantages of simple structure, convenient and reliable use.
  • the pulling part 120 includes a pulling rope in an annular structure (as shown in FIG. 3 ), which can also achieve the above-mentioned purpose.
  • the length of the pulling portion 120 (referring to the dimension when the pulling portion is stretched as a straight line) should be greater than the distance from the connecting point to the control guide wire 110 The distance between the end points is such that the pulling portion 120 can be sheathed on the control guide wire 110 from the distal end of the control guide wire 110 .
  • the length of the pulling portion 120 should also be less than twice the diameter of the stent 200 in the natural expansion state at the window 201.
  • the “natural expansion state” means that the control guide wire 110 is not The expanded state of the stent 200 (ie, the state shown in FIG. 4 ) when a pulling force is applied to the connecting portion 210 by the pulling portion 120 .
  • an embodiment of the present invention also provides a stent system
  • the stent system includes the stent device as described above, the stent system may further include a delivery guide wire and a delivery sheath, the delivery guide wire is used for Removably penetrated within the lumen of the stent, the stent device is adapted to be compressed within the delivery sheath.

Abstract

A stent device and a stent system. The stent device comprises a stent (200) and a control mechanism (100), the control mechanism (100) comprises a control guide wire (110) and a traction portion (120) arranged on the control guide wire (110), and the control guide wire (110) is arranged in an axial direction of the stent (200) and movably arranged on an inner wall of the stent (200); a window (201) is arranged on the stent (200), a connecting portion (210) and a limiting portion are further arranged on the stent, and the connecting portion (210) is arranged on the side of the stent (200) provided with the window (201), and is used for being connected to the traction portion (120); and the limiting portion is used for limiting the position of the control guide wire (110) in a circumferential direction and a radial direction of the stent (200). When the stent (200) is in an expanded state, the control guide wire (110) applies a pulling force to the connecting portion (210) by means of the traction portion (120), such that the stent wall around the window (201) sinks towards an inner cavity of the stent (200), separation from the blood vessel wall is achieved, and ischemia of a branch blood vessel caused by blocking the branch blood vessel when the window (201) is not aligned with a branch stent is avoided.

Description

一种支架装置及支架系统A bracket device and bracket system 技术领域technical field
本发明涉及医疗器械技术领域,具体涉及一种支架装置及支架系统。The invention relates to the technical field of medical devices, in particular to a stent device and a stent system.
背景技术Background technique
覆膜支架开窗技术一般应用于累及分叉血管的疾病的治疗,其兼具隔绝病变血管和保持分叉血管血流畅通的优势。但是患者的血管形态存在个体差异,因此预先开窗的覆膜支架在输送至病变位置进行释放时,容易出现窗口与分叉血管对位不准确的情况,此时若窗口周边的支架壁与血管壁贴合,会造成分叉血管封堵,引起分叉血管缺血,导致严重的脑梗、上肢缺血等并发症。不仅如此,窗口处一般设置有一个分支支架,如果窗口与分叉血管对位不准确,还会造成分支支架导丝通路建立困难,甚至无法建立分支支架导丝通路的情况。Stent graft fenestration technology is generally used in the treatment of diseases involving bifurcated vessels, and it has the advantages of isolating diseased vessels and maintaining the blood flow of bifurcated vessels. However, there are individual differences in the vascular morphology of patients. Therefore, when the pre-fenestrated stent-graft is delivered to the lesion site for release, the alignment of the window and the bifurcated blood vessel is likely to be inaccurate. At this time, if the stent wall around the window and the blood vessel are Wall fit will cause bifurcation vessel occlusion, causing bifurcation vessel ischemia, resulting in severe cerebral infarction, upper limb ischemia and other complications. Not only that, a branch stent is generally installed at the window. If the alignment of the window and the bifurcated blood vessel is not accurate, it will also cause difficulty in establishing a branch stent guide wire path, or even impossible to establish a branch stent guide wire path.
基于此,临床手术过程中,在覆膜支架释放后的一定时间内使覆膜支架的窗口周边的支架壁与血管壁保持在分离状态是非常有必要的。Based on this, during the clinical operation, it is very necessary to keep the stent wall around the window of the stent-graft in a separated state from the blood vessel wall for a certain period of time after the stent-graft is released.
发明内容SUMMARY OF THE INVENTION
本发明的目的在于提供一种支架装置和支架系统,该支架装置可有效避免在支架释放后因支架位置不准确而造成的分支血管封堵的情况。The purpose of the present invention is to provide a stent device and a stent system, which can effectively avoid the occlusion of branch blood vessels caused by the inaccurate position of the stent after the stent is released.
为实现上述目的,本发明提供了一种支架装置,包括支架和控制机构,其中,In order to achieve the above object, the present invention provides a bracket device, comprising a bracket and a control mechanism, wherein,
所述控制机构包括控制导丝和设置在所述控制导丝上的牵拉部,所述控制导丝沿所述支架的轴向布置,并用于可活动地设置在所述支架的内壁上;The control mechanism comprises a control guide wire and a pulling part arranged on the control guide wire, the control guide wire is arranged along the axial direction of the stent and is used to be movably arranged on the inner wall of the stent;
所述支架上设置有窗口、连接部和限位部;所述连接部设置在所述支架设有所述窗口的一侧,并用于与所述牵拉部连接;所述限位部用于限制所述控制导丝在所述支架的周向及径向上的位置;The bracket is provided with a window, a connecting part and a limiting part; the connecting part is arranged on the side of the bracket where the window is provided, and is used for connecting with the pulling part; the limiting part is used for restricting the position of the control guide wire in the circumferential and radial directions of the stent;
所述支架装置被配置为当所述牵拉部与所述连接部连接,且所述支架处于扩张状态时,所述控制导丝通过所述牵拉部向所述连接部施加拉力,以使 所述窗口周围的支架壁朝向所述支架的内腔凹陷。The stent device is configured such that when the pulling portion is connected to the connecting portion and the stent is in an expanded state, the control guide wire applies a pulling force to the connecting portion through the pulling portion, so as to cause the stent to be pulled. The stent wall around the window is recessed towards the lumen of the stent.
可选地,所述连接部包括第一线圈,所述牵拉部的近端与所述控制导丝上的连接点连接;Optionally, the connecting portion includes a first coil, and the proximal end of the pulling portion is connected to a connecting point on the control guide wire;
所述牵拉部从所述第一线圈中穿过并且所述牵拉部的远端套设于所述控制导丝位于所述连接点的远端侧上;the pulling portion passes through the first coil and the distal end of the pulling portion is sheathed on the distal side of the control guide wire at the connection point;
所述支架装置被配置为当所述控制导丝沿所述支架的轴向朝向所述支架的近端移动时,所述牵拉部的远端脱离所述控制导丝,并从所述第一线圈中穿过,以解除所述牵拉部与所述连接部的连接。The stent device is configured such that when the control guide wire is moved in the axial direction of the stent toward the proximal end of the stent, the distal end of the pulling portion is disengaged from the control guide wire and removed from the first end of the stent. A coil is passed through to release the connection between the pulling part and the connecting part.
可选地,所述牵拉部包括牵拉绳和第二线圈,所述牵拉绳的近端与所述控制导丝连接,所述牵拉绳的远端与所述第二线圈连接;所述牵拉绳用于穿设在所述第一线圈中,所述第二线圈用于套设在所述控制导丝上。Optionally, the pulling part comprises a pulling rope and a second coil, the proximal end of the pulling rope is connected with the control guide wire, and the distal end of the pulling rope is connected with the second coil; The pulling rope is used to pass through the first coil, and the second coil is used to be sleeved on the control guide wire.
可选地,所述牵拉部包括环形结构的牵拉绳。Optionally, the pulling portion includes a pulling rope in an annular structure.
可选地,所述连接部的数量为一个,且所述牵拉部的长度大于所述连接点到所述控制导丝的远端端点的距离,并小于处于自然扩张状态时的所述支架在所述窗口处的直径的两倍。Optionally, the number of the connecting portion is one, and the length of the pulling portion is greater than the distance from the connecting point to the distal end of the control guide wire, and is less than the stent in a natural expansion state. twice the diameter at the window.
可选地,所述限位部包括至少两个子限位部,至少两个所述子限位部沿所述支架的轴向间隔布置;所述牵拉部的远端套设在所述控制导丝上并位于相邻两个所述子限位部之间。Optionally, the limiting portion includes at least two sub-limiting portions, and the at least two sub-limiting portions are arranged at intervals along the axial direction of the stent; the distal end of the pulling portion is sleeved on the control on the guide wire and located between two adjacent sub-limiting parts.
可选地,所述子限位部包括第三线圈,所述控制导丝用于可活动地穿设在所述第三线圈中。Optionally, the sub-limiting portion includes a third coil, and the control guide wire is used to movably pass through the third coil.
可选地,至少两个所述子限位部分布在所述连接部的轴向两侧。Optionally, at least two of the sub-limiting portions are arranged on both axial sides of the connecting portion.
可选地,所述支架具有径向相对的第一侧和第二侧,所述第一侧上设置有所述窗口,所述第二侧上设置有所述限位部。Optionally, the bracket has a radially opposite first side and a second side, the first side is provided with the window, and the second side is provided with the limiting portion.
可选地,所述支架包括支架体和包覆在所述支架体上的覆膜,所述连接部和所述限位部均缝合在所述支架体上。Optionally, the stent includes a stent body and a coating covering the stent body, and both the connecting portion and the limiting portion are sewn on the stent body.
为实现上述目的,本发明还提供了一种支架系统,包括输送装置和如前任一项所述的支架装置,所述输送装置用于将所述支架装置输送至预定位置。To achieve the above objects, the present invention also provides a stent system, comprising a delivery device and the stent device according to any one of the preceding items, the delivery device is used to deliver the stent device to a predetermined position.
与现有技术相比,本发明的支架装置及支架系统具有如下优点:Compared with the prior art, the stent device and stent system of the present invention have the following advantages:
第一、前述的支架装置包括支架和控制机构,其中所述控制机构包括控制导丝和设置在所述控制导丝上的牵拉部,所述控制导丝沿所述支架的轴向布置,并用于可活动地设置在所述支架的内壁上;所述支架上开设有窗口、连接部和限位部,所述连接部设置在所述支架设有所述窗口的一侧并用于与所述牵拉部连接;所述限位部用于限制所述控制导丝在所述支架的周向及径向上的位置。所述支架装置被配置为当所述牵拉部与所述连接部连接,且所述支架处于扩张状态时,所述控制导丝通过所述牵拉部向所述连接部施加拉力,以使所述窗口周围的支架壁朝向所述支架的内腔凹陷。将该支架输送至血管内病变位置后释放,所述窗口周围的支架壁在所述控制机构的牵拉作用下朝向支架内腔凹陷而远离血管壁,从而保证分支血管不被封堵,既不会造成分支血管缺血,也不会对窗口处分支支架的导丝通路构建带来不良影响。First, the aforementioned stent device includes a stent and a control mechanism, wherein the control mechanism includes a control guide wire and a pulling portion provided on the control guide wire, and the control guide wire is arranged along the axial direction of the stent, and is used to be movably arranged on the inner wall of the bracket; the bracket is provided with a window, a connecting part and a limiting part, and the connecting part is arranged on the side of the bracket with the window and is used for connecting with all the brackets. The pulling part is connected; the limiting part is used to limit the position of the control guide wire in the circumferential and radial directions of the stent. The stent device is configured such that when the pulling portion is connected to the connecting portion and the stent is in an expanded state, the control guide wire applies a pulling force to the connecting portion through the pulling portion, so as to cause the stent to be pulled. The stent wall around the window is recessed towards the lumen of the stent. The stent is delivered to the intravascular lesion site and then released, and the stent wall around the window is concave toward the stent lumen and away from the blood vessel wall under the pulling action of the control mechanism, so as to ensure that the branch blood vessel is not blocked, neither. It will cause branch vessel ischemia, and will not adversely affect the construction of the guide wire pathway of the branch stent at the window.
第二、所述连接部包括第一线圈,所述牵拉部的近端与所述控制导丝上的连接点连接;所述牵拉部穿过所述第一线圈并且所述牵拉部的远端连接到所述控制导丝的位于所述连接点的远端侧上,以实现所述牵拉部与所述连接部的连接;所述支架装置被配置为当所述控制导丝沿所述支架的轴向朝向所述支架的近端移动时,所述牵拉部的远端脱离所述控制导丝,并穿过所述第一线圈,以解除所述牵拉部与所述连接部的连接。在将所述控制导丝撤离体外的过程中即可解除所述牵拉部与所述连接部的连接,使得临近窗口处的支架壁与血管壁贴合,操作简单方便。Second, the connecting portion includes a first coil, and the proximal end of the pulling portion is connected to a connection point on the control guide wire; the pulling portion passes through the first coil and the pulling portion The distal end of the control guide wire is connected to the distal end side of the control guide wire at the connection point, so as to realize the connection of the pulling part and the connecting part; the stent device is configured to be used when the control guide wire is When moving toward the proximal end of the stent along the axial direction of the stent, the distal end of the pulling part is separated from the control guide wire and passes through the first coil, so as to release the pulling part from the other end. the connection of the connecting part. During the process of withdrawing the control guide wire from the body, the connection between the pulling part and the connecting part can be released, so that the stent wall near the window is attached to the blood vessel wall, and the operation is simple and convenient.
附图说明Description of drawings
附图用于更好地理解本发明,不构成对本发明的不当限定。其中:The accompanying drawings are used for better understanding of the present invention and do not constitute an improper limitation of the present invention. in:
图1是本发明根据一实施例所提供的支架装置的结构示意图;1 is a schematic structural diagram of a stent device according to an embodiment of the present invention;
图2是本发明根据一实施例所提供的支架装置的控制机构的结构示意图;2 is a schematic structural diagram of a control mechanism of a stent device provided by the present invention according to an embodiment;
图3是本发明根据另一实施例所提供的支架装置的控制机构的结构示意图;3 is a schematic structural diagram of a control mechanism of a stent device provided by another embodiment of the present invention;
图4是本发明根据一实施例所提供的支架装置的支架的结构示意图;4 is a schematic structural diagram of a stent of a stent device according to an embodiment of the present invention;
图5是本发明根据一实施例所提供的支架装置植入主动脉弓时的示意图。FIG. 5 is a schematic diagram of the stent device according to an embodiment of the present invention when the stent device is implanted into the aortic arch.
图中:In the picture:
100-控制机构;110-控制导丝;120-牵拉部;121-牵拉绳,122-第二线圈;200-支架;201-窗口;210-连接部;221-子限位部。100-control mechanism; 110-control guide wire; 120-pulling part; 121-pulling rope, 122-second coil; 200-support; 201-window; 210-connecting part; 221-sub-limiting part.
具体实施方式detailed description
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。需要说明的是,本实施例中所提供的图示仅以示意方式说明本发明的基本构想,遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制,其实际实施时各组件的型态、数量及比例可为一种随意的改变,且其组件布局型态也可能更为复杂。The embodiments of the present invention are described below through specific specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the drawings provided in this embodiment are only to illustrate the basic concept of the present invention in a schematic way, so the drawings only show the components related to the present invention rather than the number, shape and the number of components in actual implementation. For dimension drawing, the type, quantity and proportion of each component can be changed at will in actual implementation, and the component layout may also be more complicated.
另外,以下说明内容的各个实施例分别具有一或多个技术特征,然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征,或仅能分开实施不同实施例中的一部或全部技术特征。换句话说,在实施为可能的前提下,本领域技术人员可依据本发明的公开内容,并视设计规范或实作需求,选择性地实施任一实施例中部分或全部的技术特征,或者选择性地实施多个实施例中部分或全部的技术特征的组合,借此增加本发明实施时的弹性。In addition, each embodiment of the following description has one or more technical features, but this does not mean that the person using the present invention must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. One or all of the technical features of the . In other words, under the premise of possible implementation, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or The combination of some or all of the technical features in the multiple embodiments is selectively implemented, thereby increasing the flexibility of the implementation of the present invention.
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。As used in this specification, the singular forms "a," "an," and "the" include plural referents, and the plural forms "a plurality" include two or more referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "installed", "connected", "connected" shall be To be understood in a broad sense, for example, it may 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 the internal communication between two elements or the interaction relationship between the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.
在本文中,术语“近端”、“远端”是从使用该医疗器械的医生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,但是“近端”通常指该医疗设备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。As used herein, the terms "proximal", "distal" are the relative orientation, relative position, orientation of elements or actions relative to each other from the perspective of the physician using the medical device, although "proximal", "distal" " is not limiting, but "proximal" generally refers to the end of the medical device that is closest to the physician during normal operation, and "distal" generally refers to the end that first enters the patient.
本发明的核心思想在于提供一种支架装置,该支架装置主要用于分叉血管处的病变治疗,例如累及分支动脉的主动脉弓处的病变。所述支架装置包括支架和控制机构。其中所述控制机构包括控制导丝和设置在所述控制导丝上的牵拉部,所述控制导丝沿所述支架的轴向布置,并可活动地设置在所述支架的内壁上。所述支架上设置有窗口、连接部和限位部,所述连接部设置在所述支架设有所述窗口一侧,并用于与所述牵拉部连接;所述限位部用于限制所述控制导丝在所述支架的周向及径向上的位置。所述支架被配置为当所述牵拉部与所述连接部连接,且所述支架处于扩张状态时,所述控制导丝通过所述牵拉部向所述连接部施加拉力,以使所述窗口周围的支架壁朝向所述支架的内腔凹陷。即,当所述支架在病变部位释放时,利用所述控制机构牵拉所述窗口周围的连接部,使得所述窗口周围的支架壁远离血管壁,从而两者之间存在间隙,血流可从该间隙处流入分支血管,避免因窗口与分支支架对位不准确发生分支血管被封堵的情况。若所述窗口处还设置有分支支架,由于窗口周围的支架壁与血管壁之间存在间隙,即使窗口与分支血管对位不准确也不会对分支支架的控制导丝通路的构建产生不良影响。The core idea of the present invention is to provide a stent device, which is mainly used for the treatment of lesions at bifurcated vessels, such as lesions at the aortic arch involving branch arteries. The stand device includes a stand and a control mechanism. The control mechanism includes a control guide wire and a pulling part arranged on the control guide wire. The control guide wire is arranged along the axial direction of the stent and can be movably arranged on the inner wall of the stent. The bracket is provided with a window, a connecting part and a limiting part, the connecting part is arranged on the side of the bracket where the window is provided, and is used for connecting with the pulling part; the limiting part is used for limiting The position of the control guide wire in the circumferential and radial directions of the stent. The stent is configured such that when the pulling part is connected to the connecting part and the stent is in an expanded state, the control guide wire applies a pulling force to the connecting part through the pulling part, so that the The bracket wall around the window is recessed toward the inner cavity of the bracket. That is, when the stent is released at the lesion site, the connecting portion around the window is pulled by the control mechanism, so that the stent wall around the window is away from the blood vessel wall, so that there is a gap between the two, and blood flow can be prevented. The branch blood vessels flow into this gap, so as to avoid the occlusion of the branch blood vessels due to inaccurate alignment of the window and the branch stent. If the window is also provided with a branch stent, since there is a gap between the stent wall and the blood vessel wall around the window, even if the window and the branch blood vessel are not accurately aligned, the construction of the control guide wire channel of the branch stent will not be adversely affected. .
更为详细地,所述连接部包括第一线圈,所述牵拉部的近端与所述控制导丝上的连接点连接;所述牵拉部从所述第一线圈中穿过并且所述牵拉部的远端套设于所述控制导丝位于所述连接点的远端侧上,再定位到所述控制导丝位于所述牵拉部与所述控制导丝的连接点的远端侧上,实现所述牵拉部与所述连接部的连接;所述支架装置被配置为当所述控制导丝沿所述支架的轴向朝向所述支架的近端移动时,所述牵拉部的远端脱离所述控制导丝,并从所述第一线圈穿过,以解除所述牵拉部与所述连接部的连接。也就是说,在施术者在完成支架的位姿调整以及分支血管的导丝通路构建(需要设置分支 支架时)完成后,通过回撤控制导丝就可以解除牵拉部与连接部的连接,使得临近所述窗口的支架壁与血管壁贴合,操作简单方便。In more detail, the connecting portion includes a first coil, and the proximal end of the pulling portion is connected to a connection point on the control guide wire; the pulling portion passes through the first coil and is The distal end of the pulling portion is sleeved on the distal side of the control guide wire at the connection point, and then positioned to the point where the control guide wire is positioned at the connection point between the pulling portion and the control guide wire. On the distal end side, the connection between the pulling part and the connecting part is realized; the stent device is configured such that when the control guide wire moves toward the proximal end of the stent along the axial direction of the stent, the stent device The distal end of the pulling part is separated from the control guide wire and passes through the first coil to release the connection between the pulling part and the connecting part. That is to say, after the operator completes the posture adjustment of the stent and the construction of the guide wire passage of the branch blood vessel (when the branch stent needs to be installed), the connection between the pulling part and the connecting part can be released by withdrawing the control guide wire. , so that the stent wall adjacent to the window is attached to the blood vessel wall, and the operation is simple and convenient.
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。附图中相同或相似的附图标记代表相同或相似的部件。In order to make the objects, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that, the accompanying drawings are all in a very simplified form and in inaccurate scales, and are only used to facilitate and clearly assist the purpose of explaining the embodiments of the present invention. The same or similar reference numbers in the drawings represent the same or similar parts.
图1示出了本发明优选实施例提供的支架装置的结构示意图,图2及图3分别示出了支架装置的两种可选的控制机构的结构示意图,图4示出了支架装置的支架的结构示意图。FIG. 1 shows a schematic structural diagram of a stent device provided by a preferred embodiment of the present invention, FIG. 2 and FIG. 3 respectively show structural schematic diagrams of two optional control mechanisms of the stent device, and FIG. 4 shows a stent of the stent device. Schematic diagram of the structure.
请参考图1至图4,所述支架装置包括控制机构100和支架200。其中,所述控制机构100包括控制导丝110和设置在所述控制导丝110上的牵拉部120,所述控制导丝110用于沿所述支架200的轴向布置,并可活动地设置在所述支架200的内壁上。所述支架200通常是覆膜支架,其上设置有与支架内腔相贯通的窗口201,所述支架200上还设置有连接部210和限位部。所述连接部210设置在所述支架200设有所述窗口201的一侧,并用于与所述牵拉部120连接。所述限位部用于限制所述控制导丝110在所述支架200的周向及径向上的位置。所述支架装置被配置为当所述牵拉部120与所述连接部210连接,且所述支架200处于扩张状态时,所述控制导丝110通过所述牵拉部120向所述连接部210施加拉力,以使所述窗口201周围的支架壁朝向所述支架200的内腔凹陷。本领域技术人员可理解,所述连接部210设置在所述窗口201的周边,在一些实施例中,所述连接部210设置在所述窗口201的边缘处,在另一些实施例中,所述连接部210与所述窗口201的边缘具有预定间距,所述预定间距根据实际情况确定,只要所述控制导丝110通过所述牵拉部向所述连接部210施加拉力时,能够使得所述窗口201周围的支架壁凹陷即可。Please refer to FIG. 1 to FIG. 4 , the bracket device includes a control mechanism 100 and a bracket 200 . Wherein, the control mechanism 100 includes a control guide wire 110 and a pulling portion 120 disposed on the control guide wire 110, the control guide wire 110 is arranged along the axial direction of the stent 200, and can move movably arranged on the inner wall of the bracket 200 . The stent 200 is usually a stent-graft, and a window 201 that communicates with the inner cavity of the stent is provided on the stent 200 , and a connecting portion 210 and a limiting portion are also provided on the stent 200 . The connecting portion 210 is disposed on the side of the bracket 200 where the window 201 is provided, and is used for connecting with the pulling portion 120 . The limiting portion is used to limit the position of the control guide wire 110 in the circumferential and radial directions of the stent 200 . The stent device is configured such that when the pulling portion 120 is connected to the connecting portion 210 and the stent 200 is in an expanded state, the control guide wire 110 passes through the pulling portion 120 to the connecting portion. 210 exerts a pulling force so that the stent wall around the window 201 is recessed toward the lumen of the stent 200 . Those skilled in the art can understand that the connecting portion 210 is arranged at the periphery of the window 201. In some embodiments, the connecting portion 210 is arranged at the edge of the window 201. In other embodiments, the The connecting portion 210 and the edge of the window 201 have a predetermined distance, and the predetermined distance is determined according to the actual situation. As long as the control guide wire 110 exerts a pulling force on the connecting portion 210 through the pulling portion, all the The bracket wall around the window 201 may be recessed.
图5示出了所述支架装置应用于累及分支血管的主动脉弓病变时的示意图。如图5所示,将所述支架装置植入患者的主动脉弓时,所述支架200设 置有所述窗口201的一侧朝向所述主动脉弓的大弯侧布置。在理想的情况下,当所述支架200释放后,一个所述窗口201应当与一个所述分支动脉对准,以使血流可从所述窗口201处流入所述分支动脉。但是在实际操作过程中,往往由于各种原因导致了窗口201与分支动脉对位不准确而封堵分支血管,本实施例提供的支架装置的控制机构100通过牵拉部120牵拉所述支架200上的连接部210,使得所述窗口201周围的支架壁朝向所述支架200的内腔的方向凹陷而与血管壁之间形成间隙,从而血流可从所述窗口201处流入所述间隙,再流入分支血管,避免分支血管缺血。当所述窗口201处需要设置分支支架时,间隙的存在也使得分支血管导丝通路的构建变得更为容易。本实施例中,所述支架200包括支架体和设置在所述支架体上的覆膜,所述连接部210和所述限位部均被缝合在所述支架200的支架体上。在其他实施例中,所述连接部210和所述限位部也可被缝合在所述覆膜上,具体根据实际情况确定。FIG. 5 shows a schematic diagram of the stent device applied to aortic arch lesions involving branch vessels. As shown in Fig. 5, when the stent device is implanted into the aortic arch of a patient, the side of the stent 200 provided with the window 201 is disposed toward the greater curvature of the aortic arch. Ideally, after the stent 200 is released, one of the windows 201 should be aligned with one of the branch arteries, so that blood flow can flow into the branch arteries from the window 201 . However, in the actual operation process, the alignment of the window 201 and the branch artery is often inaccurate due to various reasons, and the branch blood vessel is blocked. The control mechanism 100 of the stent device provided in this embodiment pulls the stent through the pulling part 120 The connecting part 210 on the 200 makes the stent wall around the window 201 recess toward the lumen of the stent 200 to form a gap with the blood vessel wall, so that blood flow can flow into the gap from the window 201 , and then flow into branch vessels to avoid branch vessel ischemia. When a branch stent needs to be arranged at the window 201, the existence of the gap also makes the construction of the branch blood vessel guide wire easier. In this embodiment, the stent 200 includes a stent body and a covering film disposed on the stent body, and both the connecting portion 210 and the limiting portion are sewn on the stent body of the stent 200 . In other embodiments, the connecting portion 210 and the limiting portion may also be sewn on the covering film, which is determined according to actual conditions.
进一步地,请重点参考图1,所述支架200具有径向相对的第一侧和第二侧,所述窗口201设置在所述第一侧上(也就是说,所述第一侧是在实际使用中临近主动脉弓大弯侧的一侧,或者在其他的分叉血管中,所述第一侧是临近有分支血管的一侧),那么所述连接部210也设置在所述第一侧上,而所述限位部优选设置在所述第二侧上,如此所述控制导丝110被可活动地设置在所述支架200的第二侧的内壁上。这样设置的好处在于,当所述支架200处于扩张状态时,所述控制导丝110施加至所述连接部210上的拉力最大化,确保临近所述窗口201的支架壁能够向所述支架200的内腔凹陷。Further, referring to FIG. 1 , the bracket 200 has a first side and a second side diametrically opposite, and the window 201 is disposed on the first side (that is, the first side is on the first side). In actual use, the side adjacent to the greater curvature of the aortic arch, or in other bifurcated vessels, the first side is the side adjacent to the branched vessel), then the connecting portion 210 is also arranged on the first side and the limiting portion is preferably arranged on the second side, so that the control guide wire 110 is movably arranged on the inner wall of the second side of the bracket 200 . The advantage of this arrangement is that when the stent 200 is in the expanded state, the pulling force exerted by the control guide wire 110 on the connecting portion 210 is maximized, ensuring that the stent wall adjacent to the window 201 can reach the stent 200 cavity depression.
进一步地,所述牵拉部120为柔软的长条形结构,其近端可通过热熔、胶粘或其他合适的方式与所述控制导丝110上的连接点连接。所述连接部210包括至少一个第一线圈。所述牵拉部从所述第一线圈中穿过,并且所述牵拉部的远端套设在所述控制导丝的位于所述连接点的远端侧上,以实现所述牵拉部120与所述连接部210的连接。同时所述支架装置被配置为当所述控制导丝110沿所述支架200的轴向朝向所述支架200的近端移动时,所述牵拉 部120的远端脱离所述控制导丝110,并从所述第一线圈中穿过,以解除所述牵拉部120与所述连接部210的连接。具体来说,所述牵拉部120的远端可从所述第一线圈的近端侧穿过所述第一线圈后,再被连接到控制导丝的位于所述连接点的远端侧上,实现所述牵拉部120与所述连接部210的连接。解除所述牵拉部120与所述连接部210的连接时,所述控制导丝110沿所述支架200的轴向朝向所述支架200的近端移动,以使所述牵拉部120的远端脱离所述控制导丝110,并从所述第一线圈的远端侧穿过所述第一线圈即可。这种结构方便施术者在完成所述分支支架导丝通路的构建后,通过向体外回撤所述控制导丝110的方式就能够将所述控制机构100从所述支架200上拆卸下来,解除所述控制导丝110通过所述连接部210施加在所述窗口201周围的支架壁上的拉力,使得所述窗口201周围的支架壁与血管壁贴合而阻隔病变。本领域技术人员可理解,所述的“第一线圈的近端侧”是指通过调整所述第一线圈的位姿使得所述第一线圈所在平面垂直于所述支架200的轴线时,所述第一线圈朝向所述支架200近端的一侧,而所述第一线圈在该位姿时朝向所述支架200的远端的一侧则为所述的“第一线圈的远端侧”。此外,本发明对所述第一线圈的数量不作限定,其还可以是两个、三个或更多个,所述牵拉部至少穿过一个所述第一线圈后再与所述控制导丝连接。Further, the pulling portion 120 is a flexible elongated structure, and the proximal end thereof can be connected to the connection point on the control guide wire 110 by hot melting, gluing or other suitable methods. The connection part 210 includes at least one first coil. The pulling part is passed through the first coil, and the distal end of the pulling part is sheathed on the distal side of the control guide wire located at the connection point, so as to realize the pulling The connection between the part 120 and the connection part 210 . Meanwhile, the stent device is configured such that when the control guide wire 110 moves toward the proximal end of the stent 200 along the axial direction of the stent 200 , the distal end of the pulling portion 120 is disengaged from the control guide wire 110 . , and pass through the first coil to release the connection between the pulling part 120 and the connecting part 210 . Specifically, the distal end of the pulling portion 120 can be connected to the distal end of the control guide wire at the connection point after passing through the first coil from the proximal end side of the first coil. Above, the connection between the pulling part 120 and the connecting part 210 is realized. When the connection between the pulling part 120 and the connecting part 210 is released, the control guide wire 110 moves toward the proximal end of the stent 200 along the axial direction of the stent 200 , so that the The distal end is separated from the control guide wire 110 and passed through the first coil from the distal end side of the first coil. This structure makes it convenient for the operator to remove the control mechanism 100 from the stent 200 by withdrawing the control guide wire 110 to the outside of the body after completing the construction of the guide wire path of the branch stent. The pulling force exerted by the control guide wire 110 on the stent wall around the window 201 through the connecting portion 210 is released, so that the stent wall around the window 201 is in close contact with the blood vessel wall to block the lesion. Those skilled in the art can understand that the "proximal side of the first coil" refers to that when the posture of the first coil is adjusted so that the plane where the first coil is located is perpendicular to the axis of the stent 200, the The side of the first coil facing the proximal end of the stent 200, and the side of the first coil facing the distal end of the stent 200 in this posture is the “distal side of the first coil” ". In addition, the present invention does not limit the number of the first coils, which may also be two, three or more. The pulling portion passes through at least one of the first coils and then communicates with the control conductor. wire connection.
更为详细地,请参考图2并结合图1,在一个示范性的实施例中,所述牵拉部120包括牵拉绳121和设置在所述牵拉绳121远端的第二线圈122。接着请参考图4并结合图1,所述限位部设置在所述支架200的内壁上,并包括至少两个子限位部221,至少两个子限位部221沿所述支架200的轴向间隔地布置,例如至少两个所述子限位部221分布在所述连接部210的轴向两侧。较佳地,每个所述子限位部221可包括第三线圈,所述控制导丝110穿设在所述第三线圈中时即被设置在所述支架200的第二侧的内壁上。In more detail, please refer to FIG. 2 in conjunction with FIG. 1 , in an exemplary embodiment, the pulling part 120 includes a pulling cord 121 and a second coil 122 disposed at the distal end of the pulling cord 121 . . Next, please refer to FIG. 4 in conjunction with FIG. 1 , the limiting portion is disposed on the inner wall of the bracket 200 and includes at least two sub-limiting portions 221 , and the at least two sub-limiting portions 221 are along the axial direction of the bracket 200 . Arranged at intervals, for example, at least two of the sub-limiting portions 221 are distributed on both axial sides of the connecting portion 210 . Preferably, each of the sub-limiting portions 221 may include a third coil, and the control guide wire 110 is disposed on the inner wall of the second side of the stent 200 when the control guide wire 110 is passed through the third coil. .
本实施例中,所述限位部可包括两个所述子限位部211。组装所述支架装置时,首先将所述控制导丝110的头端从所述支架200的近端穿入所述支架200的内腔,并穿过靠近所述支架200的近端的一个所述子限位部221;接着, 将所述牵拉部120的远端穿过所述连接部210,并使所述牵拉部120的远端从所述控制导丝110的远端套装到所述控制导丝110上;最后,使所述控制导丝110朝向所述支架200的远端移动,以使所述控制导丝110的远端穿过另一个所述子限位部221(即靠近所述支架200远端的一个子限位部221)。In this embodiment, the limiting portion may include two sub-limiting portions 211 . When assembling the stent device, firstly, the head end of the control guide wire 110 is inserted into the lumen of the stent 200 from the proximal end of the stent 200, and passed through a position close to the proximal end of the stent 200. The sub-limiting portion 221; then, the distal end of the pulling portion 120 is passed through the connecting portion 210, and the distal end of the pulling portion 120 is sheathed from the distal end of the control guide wire 110 to the on the control guide wire 110; finally, move the control guide wire 110 toward the distal end of the stent 200, so that the distal end of the control guide wire 110 passes through the other sub-limiting portion 221 ( That is, a sub-limiting portion 221) near the distal end of the stent 200.
这里,在组装后的所述支架装置中,所述牵拉部120的远端套设在所述控制导丝110位于相邻两个所述子限位部221之间的部分上,这是因为该部分的控制导丝110被两个所述子限位部211限制,使得其在所述支架200扩张时不会因为所述连接部210的反作用力而向所述窗口201方向移动,从而确保对所述连接部210有效牵拉。Here, in the assembled stent device, the distal end of the pulling portion 120 is sleeved on the portion of the control guide wire 110 located between the two adjacent sub-limiting portions 221, which is Because this part of the control wire 110 is restricted by the two sub-limiting parts 211 , it will not move towards the window 201 due to the reaction force of the connecting part 210 when the stent 200 is expanded, so that Ensure that the connecting portion 210 is effectively pulled.
组装完成的所述支架装置在所述支架200被压握后可装载于一输送系统,并被输送至病变血管中。当所述支架200在血管中释放后,所述控制机构100牵拉所述连接部210,以使所述窗口201周围的支架壁与血管壁之间形成间隙。当施术者完成支架200的位姿调整,以及完成分支血管导丝通路的构建后,在回拉所述控制导丝110的近端,以将所述控制导丝110撤出体外的过程中,所述控制导丝110的远端依次穿过两个所述子限位部221,同时所述牵拉部120脱离所述控制导丝110后,再穿过所述连接部210,即可解除所述牵拉部120与所述连接部210的连接,此时所述窗口201附近的支架壁与血管壁贴合。The assembled stent device can be loaded into a delivery system after the stent 200 is crimped and delivered to the diseased blood vessel. After the stent 200 is released in the blood vessel, the control mechanism 100 pulls the connecting portion 210 to form a gap between the stent wall around the window 201 and the blood vessel wall. After the operator completes the posture adjustment of the stent 200 and the construction of the branch vessel guide wire pathway, the operator pulls back the proximal end of the control guide wire 110 to withdraw the control guide wire 110 from the body. , the distal end of the control guide wire 110 passes through the two sub-limiting parts 221 in sequence, and at the same time, after the pulling part 120 is separated from the control guide wire 110 , it passes through the connecting part 210 again. The connection between the pulling portion 120 and the connecting portion 210 is released, and at this time, the stent wall near the window 201 is attached to the blood vessel wall.
本实施例中,所述连接部210、所述子限位部211及所牵拉部120均采用线材制作,柔软易弯曲,不会对所述支架200的压握产生不良影响,也不会损伤所述支架200。且所述连接部210、所述子限位部221及所述牵拉部120的远端均被设计为线圈,具有结构简单、使用方便可靠的优势。In this embodiment, the connecting portion 210 , the sub-limiting portion 211 and the pulling portion 120 are all made of wires, which are soft and easy to bend, and will not adversely affect the pressing and holding of the bracket 200 , nor will it The stent 200 is damaged. Moreover, the connecting portion 210 , the sub-limiting portion 221 and the distal end of the pulling portion 120 are all designed as coils, which have the advantages of simple structure, convenient and reliable use.
在替代性的实施例中,所述牵拉部120包括环形结构的牵拉绳(如图3所示),其同样可实现上述目的。此外,当所述连接部210的数量为一个时,所述牵拉部120的长度(指牵拉部拉伸为直线时的尺寸)应大于所述连接点到所述控制导丝110的远端端点的距离,使得所述牵拉部120可从所述控制导丝110的远端套装到所述控制导丝110上。并且,所述牵拉部120的长度还应小于处于自然扩张状态的所述支架200在所述窗口201处的直径的两倍, 所述“自然扩张状态”是指所述控制导丝110未通过所述牵拉部120向所述连接部210施加拉力时所述支架200的扩张状态(即图4所示的状态)。In an alternative embodiment, the pulling part 120 includes a pulling rope in an annular structure (as shown in FIG. 3 ), which can also achieve the above-mentioned purpose. In addition, when the number of the connecting portion 210 is one, the length of the pulling portion 120 (referring to the dimension when the pulling portion is stretched as a straight line) should be greater than the distance from the connecting point to the control guide wire 110 The distance between the end points is such that the pulling portion 120 can be sheathed on the control guide wire 110 from the distal end of the control guide wire 110 . In addition, the length of the pulling portion 120 should also be less than twice the diameter of the stent 200 in the natural expansion state at the window 201. The “natural expansion state” means that the control guide wire 110 is not The expanded state of the stent 200 (ie, the state shown in FIG. 4 ) when a pulling force is applied to the connecting portion 210 by the pulling portion 120 .
进一步地,本发明实施例还提供了一种支架系统,所述支架系统包括如前所述的支架装置,所述支架系统还可包括输送导丝和输送鞘管,所述输送导丝用于可活动地穿设在所述支架的内腔中,所述支架装置用于压缩在所述输送鞘管内。Further, an embodiment of the present invention also provides a stent system, the stent system includes the stent device as described above, the stent system may further include a delivery guide wire and a delivery sheath, the delivery guide wire is used for Removably penetrated within the lumen of the stent, the stent device is adapted to be compressed within the delivery sheath.
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。Although the present invention is disclosed above, it is not limited thereto. Various modifications and variations can be made in the present invention by those skilled in the art without departing from the spirit and scope of the invention. Thus, provided that these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims (11)

  1. 一种支架装置,其特征在于,包括支架和控制机构,其中:A bracket device, characterized in that it includes a bracket and a control mechanism, wherein:
    所述控制机构包括控制导丝和设置在所述控制导丝上的牵拉部,所述控制导丝沿所述支架的轴向布置,并用于可活动地设置在所述支架的内壁上;The control mechanism comprises a control guide wire and a pulling part arranged on the control guide wire, the control guide wire is arranged along the axial direction of the stent and is used to be movably arranged on the inner wall of the stent;
    所述支架上设置有窗口、连接部和限位部;所述连接部设置在所述支架设有所述窗口的一侧,并用于与所述牵拉部连接;所述限位部用于限制所述控制导丝在所述支架的周向及径向上的位置;The bracket is provided with a window, a connecting part and a limiting part; the connecting part is arranged on the side of the bracket where the window is provided, and is used for connecting with the pulling part; the limiting part is used for restricting the position of the control guide wire in the circumferential and radial directions of the stent;
    所述支架装置被配置为当所述牵拉部与所述连接部连接,且所述支架处于扩张状态时,所述控制导丝通过所述牵拉部向所述连接部施加拉力,以使所述窗口周围的支架壁朝向所述支架的内腔凹陷。The stent device is configured such that when the pulling portion is connected to the connecting portion and the stent is in an expanded state, the control guide wire applies a pulling force to the connecting portion through the pulling portion, so as to cause the stent to be pulled. The stent wall around the window is recessed towards the lumen of the stent.
  2. 根据权利要求1所述的支架装置,其特征在于,所述连接部包括第一线圈,所述牵拉部的近端与所述控制导丝上的连接点连接;The stent device according to claim 1, wherein the connecting portion comprises a first coil, and the proximal end of the pulling portion is connected to a connecting point on the control guide wire;
    所述牵拉部从所述第一线圈中穿过并且所述牵拉部的远端套设于所述控制导丝的位于所述连接点的远端侧上;the pulling portion passes through the first coil and the distal end of the pulling portion is sheathed on the distal side of the control guide wire at the connection point;
    所述支架装置被配置为当所述控制导丝沿所述支架的轴向朝向所述支架的近端移动时,所述牵拉部的远端脱离所述控制导丝,并从所述第一线圈中穿过,以解除所述牵拉部与所述连接部的连接。The stent device is configured such that when the control guide wire is moved in the axial direction of the stent toward the proximal end of the stent, the distal end of the pulling portion is disengaged from the control guide wire and removed from the first end of the stent. A coil is passed through to release the connection between the pulling part and the connecting part.
  3. 根据权利要求1或2所述的支架装置,其特征在于,所述牵拉部包括牵拉绳和第二线圈,所述牵拉绳的近端与所述控制导丝连接,所述牵拉绳的远端与所述第二线圈连接;所述牵拉绳用于穿设在所述第一线圈中,所述第二线圈用于套设在所述控制导丝上。The stent device according to claim 1 or 2, wherein the pulling part comprises a pulling wire and a second coil, the proximal end of the pulling wire is connected with the control guide wire, and the pulling The distal end of the rope is connected with the second coil; the pulling rope is used to pass through the first coil, and the second coil is used to be sleeved on the control guide wire.
  4. 根据权利要求1或2所述的支架装置,其特征在于,所述牵拉部包括环形结构的牵拉绳。The stent device according to claim 1 or 2, wherein the pulling part comprises a pulling rope in an annular structure.
  5. 根据权利要求2所述的支架装置,其特征在于,所述连接部的数量为一个,且所述牵拉部的长度大于所述连接点到所述控制导丝的远端端点的距离,并小于处于自然扩张状态时的所述支架在所述窗口处的直径的两倍。The stent device according to claim 2, wherein the number of the connecting portion is one, and the length of the pulling portion is greater than the distance from the connecting point to the distal end of the control guide wire, and Less than twice the diameter of the stent at the window in its natural expanded state.
  6. 根据权利要求2所述的支架装置,其特征在于,所述限位部包括至少 两个子限位部,至少两个所述子限位部沿所述支架的轴向间隔布置;所述牵拉部的远端套设在所述控制导丝上并位于相邻两个所述子限位部之间。The stent device according to claim 2, wherein the limiting portion comprises at least two sub-limiting portions, and the at least two sub-limiting portions are arranged at intervals along the axial direction of the stent; the pulling The distal end of the part is sleeved on the control guide wire and is located between two adjacent sub-limiting parts.
  7. 根据权利要求6所述的支架装置,其特征在于,所述子限位部包括第三线圈,所述控制导丝用于可活动地穿设在所述第三线圈中。The stent device according to claim 6, wherein the sub-limiting portion comprises a third coil, and the control guide wire is used to movably pass through the third coil.
  8. 根据权利要求6所述的支架装置,其特征在于,至少两个所述子限位部分布在所述连接部的轴向两侧。The stent device according to claim 6, wherein at least two of the sub-limiting parts are arranged on both sides of the connecting portion in the axial direction.
  9. 根据权利要求1所述的支架装置,其特征在于,所述支架具有径向相对的第一侧和第二侧,所述第一侧上设置有所述窗口,所述第二侧上设置有所述限位部。2. The stent assembly of claim 1, wherein the stent has diametrically opposed first and second sides, the first side having the window disposed thereon, and the second side having the window disposed thereon the limiting part.
  10. 根据权利要求1所述的支架装置,其特征在于,所述支架包括支架体和包覆在所述支架体上的覆膜,所述连接部和所述限位部均缝合在所述支架体上。The stent device according to claim 1, wherein the stent comprises a stent body and a coating covering the stent body, and the connecting portion and the limiting portion are both sewn on the stent body superior.
  11. 一种支架系统,其特征在于,包括输送装置和如权利要求1-10中任一项所述的支架装置,所述输送装置用于将所述支架装置输送至预定位置。A stent system, characterized by comprising a delivery device and the stent device according to any one of claims 1-10, wherein the delivery device is used to deliver the stent device to a predetermined position.
PCT/CN2021/097490 2020-08-31 2021-05-31 Stent device and stent system WO2022041903A1 (en)

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Citations (6)

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CN111329633A (en) * 2018-12-18 2020-06-26 深圳市先健畅通医疗有限公司 Implant and method of manufacturing the same
CN212415986U (en) * 2020-08-31 2021-01-29 上海微创心脉医疗科技(集团)股份有限公司 Support device and support system

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US20040138732A1 (en) * 2002-07-22 2004-07-15 Suhr William S. Apparatus and method for stenting bifurcation lesions
US20170189212A1 (en) * 2015-12-30 2017-07-06 Cook Medical Technologies Llc Hybrid trigger wire for endografts
WO2018156847A1 (en) * 2017-02-24 2018-08-30 Bolton Medical, Inc. Delivery system and method to radially constrict a stent graft
CN110022795A (en) * 2017-02-24 2019-07-16 波顿医疗公司 It being capable of controlled stent graft, delivery system and application method
CN111329633A (en) * 2018-12-18 2020-06-26 深圳市先健畅通医疗有限公司 Implant and method of manufacturing the same
CN212415986U (en) * 2020-08-31 2021-01-29 上海微创心脉医疗科技(集团)股份有限公司 Support device and support system

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