CN112842648A - Conveyor and blood flow guiding bracket system - Google Patents

Conveyor and blood flow guiding bracket system Download PDF

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Publication number
CN112842648A
CN112842648A CN202011632710.8A CN202011632710A CN112842648A CN 112842648 A CN112842648 A CN 112842648A CN 202011632710 A CN202011632710 A CN 202011632710A CN 112842648 A CN112842648 A CN 112842648A
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China
Prior art keywords
blood flow
inner core
core assembly
clamping section
clamping
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Granted
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CN202011632710.8A
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Chinese (zh)
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CN112842648B (en
Inventor
褚华磊
廖成
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Juhui Medical Technology Shenzhen Co ltd
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Juhui Medical Technology Shenzhen Co ltd
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Priority to CN202111503496.0A priority Critical patent/CN113995550A/en
Priority to CN202011632710.8A priority patent/CN112842648B/en
Publication of CN112842648A publication Critical patent/CN112842648A/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
    • 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
    • A61F2/962Instruments 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/068Modifying the blood flow model, e.g. by diffuser or deflector
    • 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
    • A61F2002/9505Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • 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
    • A61F2002/9665Instruments 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 with additional retaining means

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

A conveyor includes a core assembly and a restraint. The restraint member rotationally sets up in the inner core subassembly, the restraint member includes solid fixed ring from near-end to distal end in proper order, connecting rib and clamping section, the both ends of connecting rib are connected with solid fixed ring and clamping section respectively, gu fixed ring rotationally sets up in the inner core subassembly, the clamping section has contraction configuration and extension configuration, in contraction configuration, the clamping section is used for the near-end centre gripping with blood flow guide support between inner core subassembly and clamping section, and the clamping section is close to the coefficient of friction on the surface of inner core subassembly and is greater than the coefficient of friction on the surface that the inner core subassembly was kept away from to the clamping section, in extension configuration, clamping section and blood flow guide support separation. The conveyor can avoid the blood flow guide support from twisting and slipping in the conveying process, has small pushing resistance and is easy to load. The present application further provides a blood circuit guide support system.

Description

Conveyor and blood flow guiding bracket system
Technical Field
The invention relates to the technical field of medical instruments, in particular to a conveyor and a blood flow guide support system.
Background
This section provides background information related to the present disclosure only and is not necessarily prior art.
Intracranial aneurysms are usually abnormal bulges on the wall of an intracranial artery, and are the first causes of subarachnoid hemorrhage. Subarachnoid hemorrhage is one of the main types of hemorrhagic stroke in clinic. The means of aneurysm treatment mainly include two kinds of operation clamping and intervention treatment, and clinical trials find that the mortality rate of the intervention treatment of aneurysm patients is lower than that of the operation treatment.
The blood flow guiding support is an emerging intracranial aneurysm treatment method in recent years, and has the principle of reconstructing a correct path of a blood vessel at the position of an aneurysm, recovering the blood flow direction, remodeling the blood flow direction of the intracranial blood vessel, and gradually reducing and eliminating the aneurysm.
The blood flow guide support needs to be used with a conveyor in a matched mode, the friction part with the elastic silica gel pad on the conveying guide wire of the conveyor pushes the blood flow guide support to the position of an aneurysm through a micro-catheter and releases the blood flow guide support, and the specific principle is as follows: elastic silica gel pad is through the extrusion blood flow direction support inner wall, on the inner wall of pipe is led to the blood flow direction support laminating to little to the pipe, when the propelling movement part of promotion conveyer, because elastic silica gel pad and blood flow direction support's frictional force is greater than the frictional force of blood flow direction support and pipe, elastic silica gel pad and blood flow direction support are the state of relative rest, and blood flow direction support and the pipe is gliding state a little relatively of conveyer, thereby realize the transport of blood flow direction support in little pipe, but this kind of mode has following problem:
1) in the pushing process, friction force is generated between the blood flow guiding device and the inner wall of the micro catheter to cause certain pushing resistance, and when the blood flow guiding device passes through a bent blood vessel, the pushing resistance is particularly obvious, and even unsmooth pushing can occur;
2) in the pushing process, the blood flow guide support and the conveying guide wire may slide relatively, so that the whole blood flow guide support moves backwards relative to the conveyor, the tail part of the blood flow guide support is easy to form wire stacking deformation, after the support is released, the tail part of the blood flow guide support may not be restored to a preset shape, and the narrow opening of the support after implantation can occur, so that the postoperative effect of a patient is affected;
3) when a blood vessel is bent, the conveying guide wire can be uncontrollably twisted, and the blood flow guide support rotates along with the conveying guide wire due to the limitation of the conveying guide wire and the pushing component of the conveyor on the blood flow guide support, so that the blood flow guide support is twisted, and when the blood flow guide support is released, the blood flow guide support cannot be expanded and opened normally, so that the use effect is influenced;
4) because the head end and the tail end of the blood vessel guiding bracket are generally open weaving wire tail ends, when the blood vessel guiding bracket is preloaded to the loading catheter, the tail ends of the weaving wires are easily clamped at the catheter port and cannot smoothly enter the loading catheter.
Disclosure of Invention
The object of the present invention is to solve at least one of the problems of the existing conveyors. The purpose is realized by the following technical scheme:
embodiments of the present application provide a conveyor, including:
an inner core assembly; and
the inner core assembly comprises an inner core assembly, the restraint member is rotatably arranged on the inner core assembly, the restraint member sequentially comprises a fixing ring, a connecting rib and a clamping section from a near end to a far end, two ends of the connecting rib are respectively connected with the fixing ring and the clamping section, the fixing ring is rotatably arranged on the inner core assembly, the clamping section has a contraction configuration and an expansion configuration, in the contraction configuration, the clamping section is used for clamping the near end of the blood flow guide support between the inner core assembly and the clamping section, the friction coefficient of the surface of the inner core assembly close to the clamping section is larger than that of the surface of the inner core assembly far away from the clamping section, and in the expansion configuration, the clamping section is separated from the blood flow guide support.
In one embodiment, the clamping section comprises a clamping piece and a woven net connected with the clamping piece, the woven net and the clamping piece are connected end to form a tubular structure, and a film coating layer is arranged on the woven net.
In one embodiment, the holding pieces and the woven net are both multiple, and the holding pieces and the woven net are alternately distributed.
In one embodiment, the holding pieces and the woven net are of an integral structure.
In one embodiment, a silica gel gasket is arranged on the surface, close to the inner core assembly, of the clamping sheet, a gasket is arranged at a position, corresponding to the clamping sheet, of the inner core assembly, and the gasket is sleeved on the inner core assembly.
In one embodiment, the core assembly is provided with a first developing member and a second developing member, the first developing member is located at the distal end of the gasket, and the second developing member is located at the proximal end of the gasket.
In one embodiment, the surface of the clamping sheet far away from the inner core assembly is provided with a smooth layer.
In one embodiment, the fixing ring is a developing structure.
In one embodiment, the inner core assembly comprises a delivery guide wire and a pushing rod connected with the delivery guide wire, and the restraint piece is rotatably arranged on the delivery guide wire.
In one embodiment, the connecting ribs are provided with hollow structures.
A blood flow guide support system comprises a blood flow guide support and a conveyor, wherein the conveyor comprises any one of the conveyors, the blood flow guide support is sleeved on an inner core assembly, and the proximal end of the blood flow guide support is bound between a constraint piece and the inner core assembly.
In one embodiment, the blood flow guiding support is woven by metal wires, each metal wire comprises an inner layer and an outer layer arranged on the inner layer, the inner layer is made of a developing material, and the outer layer is made of an elastic material.
The conveyor and the blood flow guiding bracket system at least have the following beneficial effects:
1) the restraint member on the conveyor can wrap the proximal end of the blood flow guide support, so that the blood flow guide support can be conveniently preassembled into the loading catheter, the open metal wire at the proximal end of the blood flow guide support is prevented from being clamped at the catheter port, and the loading difficulty of the blood flow guide support is reduced.
2) The friction coefficient of the clamping section of the restraint piece far away from the surface of the inner core assembly is small (the surface is made of nickel-titanium alloy and provided with a smooth layer), so that the friction force between the restraint piece and the micro catheter can be reduced, and the resistance in pushing is reduced.
3) The blood flow guide support is restrained between the silica gel gasket of the restraint piece and the gasket of the conveyor, the inner layer and the outer layer of the blood flow guide support are both extruded and restrained, friction force can be increased, the blood flow guide support is prevented from slipping on the conveyor, and the reliability of connection between the blood flow guide support and the conveyor is improved.
4) The restraint part is rotationally arranged on the inner core assembly, when the inner core assembly is twisted in the conveying process, the restraint part and the blood flow guide support can not rotate along with the conveying guide wire, so that the blood flow guide support can not be twisted, and the problem that the blood flow guide support cannot be normally expanded and opened in the releasing process to influence the using effect is solved.
Drawings
Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to refer to like parts throughout the drawings. In the drawings:
FIG. 1 is a schematic structural view of a blood flow directing stent system in accordance with an embodiment of the present invention;
FIG. 2 is a schematic structural view of a blood flow directing stent of the blood flow directing stent system shown in FIG. 1;
FIG. 3 is a schematic diagram of the structure of the delivery device of the blood flow directing stent system shown in FIG. 1;
FIG. 4 is a schematic structural view of a restraint of the transporter shown in FIG. 3 in an expanded state;
FIG. 5 is a schematic illustration of the restraint of the conveyor of FIG. 3 in a compressed state;
FIG. 6 is a schematic diagram of a push rod of the conveyor shown in FIG. 3 in one embodiment;
FIG. 7 is a schematic diagram of a pusher bar of the conveyor shown in FIG. 3 in another embodiment;
fig. 8-15 are schematic views of the blood flow directing stent system of the present application during operation, respectively;
FIG. 16 is a schematic representation of a prior art blood flow directing stent visualized under DSA;
FIG. 17 is a schematic representation of the blood flow directing stent of FIG. 2 visualized under DSA
Fig. 18 is a schematic structural view of a constraining member according to a second embodiment of the present application.
Detailed Description
Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.
It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
For convenience of description, spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "above", and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" can include both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
In this application, the end closer to the operator is referred to as the "proximal end" and the end farther from the operator is referred to as the "distal end" in use, and the "proximal end" and the "distal end" of any component of the blood flow guide stent system are defined according to this principle.
Referring to fig. 1, a blood flow guiding stent system 10 according to a first embodiment of the present application includes a blood flow guiding stent 100 and a delivery device 200, wherein the delivery device 200 is used to deliver the blood flow guiding stent 100 to a lesion site (e.g., an aneurysm).
Please refer to fig. 2, which is a schematic structural diagram of a blood flow guiding stent 100 according to the present application. The blood flow guiding bracket 100 is formed by weaving and shaping 24-96 metal wires. For example, the blood flow directing stent 100 is woven from 36, 48 or 64 wires. In one embodiment, the wire diameter of the wire is 0.01mm to 0.05mm, preferably 0.02mm to 0.03 mm. In one embodiment, the PPI of the blood flow guiding stent 100 is 230-300. In the present application, PPI is the braid pick count, i.e., the mesh count of the blood flow directing stent over a 1 inch axial length. In one embodiment, the PPI of the blood flow guiding stent 200 is 250-. In one embodiment, the blood flow directing stent 200 has a diameter of 1.5mm to 1.8 mm.
The existing blood flow guiding stent is generally formed by mixing and weaving nickel-titanium alloy wires or cobalt-chromium alloy wires and 2-8 platinum developing wires, the stent with the structure cannot effectively observe the effect of attaching all the metal wires to blood vessels under DSA (digital subtraction angiography), and fig. 16 is a graph showing the effect of developing the blood flow guiding stent under DSA in the prior art. In one embodiment, the metal wire includes an inner layer and an outer layer disposed on the inner layer, the inner layer is made of a developing material, such as platinum and its alloy, or a metal material with better developing property, such as tantalum, and the outer layer is made of an elastic material, such as cobalt-nickel alloy, nickel-titanium alloy, and the like. Because the inner layer is made of developable materials, the blood flow guide support 200 can be effectively developed under DSA, and the fitting condition of the blood flow guide support 200 and the blood vessel can be effectively observed. Fig. 17 is a diagram illustrating the effect of the blood flow guiding stent 200 of the present application on DSA visualization. In one embodiment, the inner layer has a cross-sectional area of 20% to 50% of the wire cross-sectional area, preferably 30% to 45% of the wire cross-sectional area.
In one embodiment, the wire surface of the blood flow directing stent 200 is provided with an anti-thrombogenic layer. Specifically, the material of the antithrombotic coating adopts phosphorylcholine which is a main component of lecithin forming an outer structure of a cell membrane, the surface of a phosphatidylcholine group with equal positive and negative charges is known to have good blood compatibility, and the coating has the advantages of reducing the occurrence of thrombus on the surface of a blood flow guide support and preventing the complication of thromboembolism after a patient is implanted into the blood flow guide support. In one embodiment, the anti-thrombus coating can be heparin, which is a commonly used clinical blood coagulation substance and can effectively prevent thrombus formation.
Referring to fig. 3, the conveyor 100 includes an inner core assembly 110 and a constraining member 120, wherein the constraining member 120 is rotatably disposed on the inner core assembly 110. The inner core assembly 110 includes a delivery guide wire 111 and a pushing rod 112 connected to the delivery guide wire, and the constraining member 120 is rotatably disposed on the delivery guide wire 111. Because the restriction member 120 can rotate relative to the delivery guide wire 111, when the delivery guide wire 111 is twisted during delivery, the restriction member 120 and the blood flow guiding stent 200 can not rotate along with the delivery guide wire 111, so that the blood flow guiding stent 200 can not be twisted, and the blood flow guiding stent 200 can not be expanded and opened normally during release to avoid influencing the use effect.
In one embodiment, the diameter of the delivery guidewire 111 increases from the distal end to the proximal end, with the distal end of the delivery guidewire 111 having a diameter of 0.03mm to 0.1mm and the proximal end having a diameter of 0.1mm to 0.2 mm. The material of the delivery guide wire 111 is stainless steel or nickel-titanium alloy.
In one embodiment, inner core assembly 110 further comprises a visualization spring coil 113 disposed at the distal end of delivery guidewire 111, i.e., visualization spring coil 112 is located at the distal-most end of inner core assembly 110 to ensure that the distal end of inner core assembly 110 is visible under DSA to help determine the position and direction of movement of delivery apparatus 10 relative to the surrounding blood vessel. In one embodiment, the developing spring coil 113 is formed by winding a metal wire, the material of the metal wire may be platinum, tungsten, gold, silver, tantalum, nickel-titanium alloy, cobalt-chromium alloy, platinum-tungsten alloy, platinum-iridium alloy, etc., the metal wire has a certain developing property under DSA (digital subtraction angiography), and the wire diameter of the metal wire is between 0.01 and 0.1 mm. In one embodiment, the diameter of the development spring coil 113 is between 0.2-0.5 mm.
In one embodiment, the distal end of the delivery guidewire 111 is further provided with a distal developing member 114, the distal developing member 114 is disposed at the position where the delivery guidewire 111 is connected to the developing spring coil 112, and the distal developing member 114 is used for developing the position of the distal end of the positioning blood flow guide stent 200. The distal developing member 114 is made of a developable metal material, and the material of the metal wire may be platinum, tungsten, gold, silver, tantalum, nickel-titanium alloy, cobalt-chromium alloy, platinum-tungsten alloy, platinum-iridium alloy, etc. The distal developing member 114 is a hollow structure with a circular hole, and the distal developing member 114 passes through the delivery guide wire 111 and is fixed to the proximal end of the developing spring coil 113. In one embodiment, the distal end of the distal visualization member 114 is cone-shaped and the proximal end is cylindrical, and the proximal end of the distal visualization member 114 can be used to abut against the distal end of the blood flow guiding stent 200, i.e., the distal end of the blood flow guiding stent 200 overlaps the proximal end of the distal visualization member 114 when assembled. In one embodiment, the diameter of the cylinder at the proximal end of the distal developer member 114 is 0.3mm to 0.6 mm.
In one embodiment, the constraint 120 is rotatably disposed at the proximal end of the delivery guidewire 111. Referring to fig. 4, the constraining member 120 includes a fixing ring 121, a connecting rib 122 and a clamping section 123 sequentially from the proximal end to the distal end, and two ends of the connecting rib 122 are respectively connected to the fixing ring 121 and the clamping section 123. Referring to fig. 3, the fixing ring 122 is rotatably disposed on the inner core assembly 110, the clamping section 123 has a contracted configuration and an expanded configuration, in the contracted configuration, the clamping section 123 is used for clamping the proximal end of the blood flow guiding stent 200 between the inner core assembly 110 and the clamping section 123, the friction coefficient of the surface of the clamping section 123 close to the inner core assembly 110 is greater than that of the surface of the clamping section 123 on the side far from the inner core assembly 110, and in the expanded configuration, the clamping section 123 is separated from the blood flow guiding stent 200. When the delivery device is pushed into the microcatheter, the friction between the blood flow guiding stent 200 and the surface of the clamping section 123 close to the inner core assembly 110 is greater than the friction between the surface of the clamping section 123 far away from the inner core assembly 110 and the inner wall of the microcatheter, so that the blood flow guiding stent 200 can be prevented from slipping on the restraining element 120.
In one embodiment, the clamping section 123 includes clamping pieces 1231 and a woven mesh 1232 connected to the clamping pieces 1231, the woven mesh 1232 and the clamping pieces 1231 are connected end to form a tubular structure, and the woven mesh 1232 is provided with a film coating layer 1234. In one embodiment, the clamping pieces 1231 and the woven net 1232 are both plural, and the clamping pieces 1231 and the woven nets 1232 are alternately distributed. In the illustrated embodiment, the clamping pieces 1231 and the woven mesh 1232 are three, and the three clamping pieces 1231 and the three woven mesh 1232 together form a mesh structure. In one embodiment, the membrane layer 1234 overlies the inner layer (i.e., the surface proximate to the inner core assembly 110) of the woven mesh 1232, and the membrane layer 1234 may be a PTFE membrane.
Fig. 4 is a schematic structural view of the constraining member 120 in the expanded state. In the natural state, the restraint 120 is in an expanded state. The mesh 1232 is naturally unfolded and forms a tubular structure with the outer diameter of 1mm-4mm with the clamping pieces 1231. Fig. 5 is a schematic structural view of the constraining member 120 in a compressed state. In the compressed state, the mesh 1231 is compressed, and encloses a tubular structure with the holding pieces 1231 having an outer diameter of 0.5mm to 0.6 mm. The outer diameters of the woven mesh 1232 and the clamping pieces 1231 in the expanded state and the compressed state may be designed as necessary so that the blood flow guiding stent 200 can be constrained between the inner core member 110 and the constraining member 120 in the compressed state, and the blood flow guiding stent 200 can be released from the constraining member 120 in the expanded state.
Because when restraint member 120 is in the compression state, clamping piece 1231 and braided network 1232 can enclose into and seal seamless tubular structure (the gap after the compression of braided network 1232 can be covered by coating 1234), after blood flow guide holder 200 loads, clamping piece 1231 and braided network 1232 can live with the complete parcel of blood flow guide holder 200, compare with netted restraint structure, the structure of clamping piece 1231 and braided network 1232 of this application can avoid the about piece 120 that spills of weaving silk of blood flow guide holder 200 tip, can effectively avoid blood flow guide holder 200 card in the pipe. In addition, in the expanded state, the knitted net 1232 and the clamping pieces 1231 may be enclosed to form a closed seamless tubular structure (the meshes of the knitted net 1232 are covered by the film layer 1234), which may prevent the knitted wires at the end of the blood flow guiding stent 200 from penetrating into the meshes when released, and reduce the probability that the blood flow guiding stent 200 and the constraining member cannot be separated.
In addition, the mesh grid 1232 can have certain constraint effect on the clamping pieces 1231, so that the clamping pieces 1231 can form a tubular structure in a compressed state, the situation that the braided wire at the end part of the blood flow guide bracket 200 leaks out of the constraint part 120 due to dislocation between the clamping pieces 1231 is avoided, and the assembly difficulty is reduced.
In one embodiment, the clamping pieces 1231 and the mesh grid 1232 are integrally formed, and in particular, the clamping pieces 1231 and the mesh grid 1232 are formed by engraving superelastic nickel titanium tubes. In this embodiment, the clamping pieces 1231, the mesh 1232, and the connecting ribs 122 are all formed by engraving through the same nitinol tube.
In one embodiment, the fixing ring 121 is a developing structure, and the relative position of the constraining member 120 and the nozzle of the micro-catheter can be observed through the fixing ring 121. Typically, the distal nozzle of the microcatheter is provided with a visualization ring, and when the retaining ring 121 is beyond the position of the visualization ring at the distal end of the microcatheter, the restriction member 120 is completely removed from the microcatheter, the restriction member 120 is in an expanded state, and the blood flow directing stent 200 is completely withdrawn from the microcatheter, and the delivery device 100 can be withdrawn to allow the delivery device 100 to enter the microcatheter.
In one embodiment, the fixing ring has a double-layer structure, which includes an inner layer made of developing material and an outer layer made of the same material as the connecting ribs 122, and the inner layer and the outer layer can be connected together by welding or bonding. In one embodiment, the outer layer, the connecting ribs 122, and the clamping section 123 are formed by engraving a single nitinol tube, so that the structure of the constraining member 120 is more stable. In one embodiment, the inner diameter of the outer layer is the same as the outer diameter of the inner layer, and the axial length of the inner and outer layers is equal. In one embodiment, the inner layer of the retaining ring 121 has an inner diameter of 0.16mm to 0.30 mm. Of course, the inner diameter of the inner layer of the retaining ring 121 can also be designed according to actual needs, such as according to the outer diameter of the delivery guidewire 111, so that the retaining ring 121 can rotate on the delivery guidewire 111.
Referring to fig. 4, one end of the connecting rib 122 is connected to the clamping piece 1231, and the other end is connected to the fixing ring 121. In the illustrated embodiment, the connecting ribs 122 are in a strip structure, a connecting rib 122 is connected to each clamping piece 1231, and a plurality of connecting ribs 122 are uniformly distributed along the circumferential direction of the fixing ring 121.
In an embodiment, a silicone gasket 1233 is disposed on the surface of the clamping piece 1231 close to the core assembly 110, and a gasket 115 is disposed at a position of the core assembly 110 corresponding to the clamping piece 1231, wherein the gasket 115 is sleeved on the core assembly 110. In the illustrated embodiment, the size of the silicone gasket 1233 is the same as that of the clamping pieces 1231, each clamping piece 1231 is provided with a silicone gasket 1233, and by adding the silicone gasket 1233, the friction coefficient of the silicone gasket 1233 is larger, so that the friction coefficient of the clamping pieces 1231 close to the surface of the core assembly 110 is larger. The gasket 115 is sleeved on the conveying guide wire 111, when the constraint piece 120 is in a compressed state, the silica gel gasket 1233 can be matched with the gasket 115, and when the constraint piece is in a compressed state, the blood flow guide support 200 is constrained between the gasket 115 and the silica gel gasket 1233, so that the inner layer and the outer layer of the blood flow guide support 200 are respectively constrained by the gasket 115 and the silica gel gasket 1233, the blood flow guide support can have larger static friction force, and the blood flow guide support 200 is prevented from slipping on the conveyor 100.
In one embodiment, the gasket 115 has a double-layer structure, the inner layer is a circular tube made of polymer, the circular tube can be made of polypropylene, polyimide, or the like, and the outer layer is silica gel. In one embodiment, the inner layer has an inner diameter of 0.16mm to 0.25mm and an outer diameter of 0.3mm to 0.4mm, the outer layer has an outer diameter of 0.55mm to 0.60mm, the inner diameter of the outer layer is determined according to the outer diameter of the inner layer, and the length of the gasket 115 is 2mm to 4 mm. It should be noted that in other embodiments, the size of the washer 115 can be designed to match the particular delivery guidewire 111.
In one embodiment, the surfaces of the gripping sheets 1231 distal to the inner core assembly 110 are provided with a smooth layer, for example, the surfaces of the gripping sheets 1231 distal to the inner core assembly 110 are provided with a hydrophilic coating of ultra-smooth PTFE. In other embodiments, the smooth layer may be made of other materials, and the smooth layer mainly reduces the friction coefficient of the surface of the clamping sheet 1231 away from the inner core assembly 110, so as to reduce the friction between the clamping sheet 1231 and the microcatheter during the pushing process, thereby reducing the pushing resistance.
In one embodiment, the delivery guidewire 111 is further provided with a first visualization member 116 and a second visualization member 117, the first visualization member 116 being located at the distal end of the washer 115 and the second visualization member 117 being located at the proximal end of the washer 115. Specifically, the proximal end of the first developer 116 abuts the distal end of the washer 115, and the distal end of the second developer 117 abuts the proximal end of the washer. In one embodiment, the first developing member 116 is made of the same material as the distal developing member 113, the first developing member 116 has a similar structure to the distal developing member 113, and the distal end of the first developing member 116 is cone-shaped and the proximal end thereof is cylindrical. In one embodiment, the outer diameter of the cylinder of the first developer 116 is the same as the outer diameter of the washer 115, i.e., the outer surface of the first developer 116 is flush with the washer 115. In one embodiment, the outer diameter of the cylinder of the first developing member 115 is 0.3mm to 0.5 mm. The material of the second developing member 117 is the same as that of the first developing member 116. Referring to fig. 3, the second developing member 117 includes two cylinders coaxially and integrally disposed, wherein the diameter of the cylinder disposed near the gasket 115 is smaller than that of the cylinder disposed far from the gasket 115. In one embodiment, the smaller diameter cylinder has an outer diameter of 0.3mm to 0.5mm and the larger diameter cylinder has an outer diameter of 0.5mm to 0.6 mm. The sum of the length of the second smaller diameter cylinder and the axial length of the washer 115 is approximately equal to the axial length of the gripping tab 1231. After the blood flow guide holder 200 and the transporter 100 are loaded, the proximal end of the blood flow guide holder 200 is held between the holding piece 1231 and the washer 115, and covers the cylindrical portion of the first developing member 116 and the smaller diameter cylindrical portion of the second developing member 117, and it can be determined whether the blood flow guide holder 200 is displaced relative to the transporter 100 by the first developing member 116 and the second developing member 117.
Referring also to FIG. 6, the distal end of the push rod 112 is connected to the proximal end of the delivery guidewire 111, and the outer diameter of the push rod 112 is larger than the outer diameter of the delivery guidewire 111. The fixing ring 122 is rotatably disposed on the delivery guidewire 111 and is constrained between the second development member and the distal end of the push rod 112. In one embodiment, the push rod 112 has an outer diameter of 0.4mm to 0.6 mm. The pushing rod 112 includes a distal portion 1121 and a proximal portion 1122 connected to the distal portion 1121, and the hardness of the distal portion 1121 is less than that of the proximal portion 1122. The distal portion 1121 is a hypotube, and specifically, the distal portion 1121 of the push rod 112 may be formed by laser engraving a spiral hollow groove through a nickel-titanium alloy or stainless steel metal tube. Referring to fig. 6, the distal portion 1121 of the pushing rod 112 at least includes a section a, a section B, a section C, a section D and a section E from the distal end to the proximal end, the pitch of the section a is smaller than that of the section B, the pitch of the section B is smaller than that of the section C, the pitch of the section C is smaller than that of the section D, and the pitch of the section D is smaller than that of the section E, so that the distal portion 1121 has a gradual stiffness to facilitate the distal portion 1121 passing through a curved blood vessel. In one embodiment, the distal portion 1121 of the push rod 112 is further provided with a polymeric sleeve (e.g., a PTFE sleeve) to prevent the distal portion 1121 from unrotating. The proximal portion 1122 of the pushing rod 112 is a solid structure, in the illustrated embodiment, the proximal portion 1122 of the pushing rod 112 includes a metal tube extending from the distal portion 1121 of the pushing rod and a solid steel wire inserted into the metal tube, and the metal tube of the proximal portion 1122 has no hollow structure. In other embodiments, the proximal portion 1122 of the push rod 112 can have other configurations. Referring to fig. 7, the proximal portion 1122 of the push rod 112 may have other configurations, and the proximal portion 1122 includes a solid steel wire connected to the distal portion 1121 by welding. The distal portion 1121 of the pushing rod 112 is relatively low in hardness and relatively flexible, and can pass through a bent blood vessel, and the proximal portion 1122 is relatively high in hardness and relatively high in supporting strength, so that the pushing rod can have relatively good pushing performance. In one embodiment, the distal portion 1121 has a length of 70mm to 120mm and the push rod 112 has an overall length of 150mm to 200 mm.
Referring to fig. 8-15, a method of operating the blood flow directing stent system 10 is also provided according to an embodiment of the present application. The blood flow directing stent system 10 also includes a loading catheter 20.
Step S1: the delivery device 10 is advanced into the loading catheter 20 with the loading catheter 20 positioned at the pusher rod 112, and the blood flow directing stent 200 is advanced over the delivery guidewire 111 with its proximal end tucked into the constraint 120 in the expanded state. Fig. 8 is a schematic diagram of the assembly process of blood flow directing stent system 10 and loading catheter 20.
Step S2: withdrawing the pusher bar 112, with the constraint 120 in compression within the loading catheter 20 and the blood flow directing stent 200 secured between the clamping segment 123 and the washer 115, continues to withdraw the pusher bar 112 until the blood flow directing stent 200 is fully pulled into the loading catheter 20. Fig. 9 is a schematic view of the configuration of blood flow directing stent system 10 within loading catheter 20.
Step S3: the loading catheter 20 is inserted into the microcatheter 30 (at which point the microcatheter 30 has reached the lesion), the transporter 100 is advanced, and blood flow is directed to the stent 200 and advanced into the microcatheter 30. Fig. 10 is a schematic view of the loading catheter 20 loaded with the blood flow directing stent system 10 inserted into the microcatheter 30, and fig. 11 is a schematic view of the blood flow directing stent system 10 positioned within the microcatheter 30 with the constraining member 120 in a compressed state within the microcatheter 30.
Step S4: the pusher rod 112 of the delivery device 100 is pushed until the distal end of the blood flow directing stent 200 reaches the distal end of the microcatheter 30 (as may be determined by observing the relative position of the distal visualization member 114 and the visualization ring 31 at the distal end of the microcatheter 30), the microcatheter 30 is withdrawn and the distal end of the blood flow directing stent 200 is released from the distal end of the microcatheter 30 and self-expands within the vessel. Fig. 12 is a partially released configuration of flow directing stent 200, wherein the distal end of flow directing stent 200 has been released from the distal end of microcatheter 30 and self-expanded and deployed, and the proximal end of flow directing stent 200 is also constrained within microcatheter 30 by constraining member 120, and wherein if flow directing stent 200 is not properly positioned, push rod 112 may be retracted to pull flow directing stent 200 back into microcatheter 30.
Step S5: when the blood flow guiding stent 200 is properly released, the microcatheter 30 is continuously withdrawn, the constraining member 120 is gradually exposed from the microcatheter 30 until the securing ring 121 of the constraining member 120 is exposed from the microcatheter 30, and the delivery device 100 is withdrawn, allowing the blood flow guiding stent 200 to fully expand and deploy. Fig. 13 shows the position of the release of the blood flow directing stent 200 by holding the delivery device 100 while pushing the microcatheter 30 to retract the constraining member 120 into the microcatheter 30, sandwiching the proximal end of the blood flow directing stent 200 between the constraining ring 121 of the constraining member 120 and the distal end of the microcatheter 30, and the proximal end of the blood flow directing stent 200 within the constraining member 120. Fig. 14 is a schematic view of the blood flow directing stent 200 after it has been fully released within a blood vessel.
Step S6: the delivery device 100 is withdrawn into the microcatheter 30, and the microcatheter 30 and delivery device 100 are withdrawn from the body. Fig. 15 is a schematic view of the restraint 120 retracted into the microcatheter 30.
The blood flow guiding bracket system 10 has at least the following beneficial effects:
1) the restraining member 120 on the delivery device 10 can wrap the proximal end of the blood flow guide stent 200, so that the blood flow guide stent 200 can be conveniently pre-installed in a loading catheter, the open metal wire at the proximal end of the blood flow guide stent is prevented from being clamped at the catheter port, and the loading difficulty of the blood flow guide stent 200 is reduced.
2) The gripping section 123 of the constraining member 120 has a low coefficient of friction (the surface is nitinol and is provided with a smooth layer) away from the surface of the inner core assembly 110, which reduces the friction between the constraining member and the microcatheter, thereby reducing the resistance to pushing.
3) The blood flow guide bracket 200 is constrained between the silica gel gasket 1233 of the constraining piece 120 and the gasket 115 of the conveyor 100, and the inner layer and the outer layer of the blood flow guide bracket 200 are both extruded and constrained, so that the friction force can be increased, the blood flow guide bracket 200 is prevented from slipping on the conveyor 100, and the connection reliability of the blood flow guide bracket 200 and the conveyor 100 is improved.
4) The restriction member 120 is rotatably disposed on the inner core assembly 110, and when the delivery guide wire 111 is twisted during delivery, the restriction member 120 and the blood flow guiding stent 200 may not be rotated along with the delivery guide wire 111, so that the blood flow guiding stent 200 may not be twisted, thereby preventing the blood flow guiding stent 200 from being opened due to abnormal expansion during release, which may affect the use effect.
Referring to fig. 18, the blood flow guiding stent system (not shown) of the second embodiment of the present application has substantially the same structure as the blood flow guiding stent system 10 of the first embodiment, but differs therefrom in that a hollow-out structure 1221 is disposed on the connecting rib 122a of the constraining member 120a of the conveyor (not shown). Through setting up hollow out construction 1221, can increase the compliance of connecting rib 122a, can make connecting rib 122a change and buckle and can not produce great elasticity to can be better with restraint piece 120a pull-in to loading pipe or little pipe in.
In one embodiment, the number of the hollow structures is multiple, and the plurality of hollow structures 1221 are arranged along the axial direction of the connecting rib 122 a. The hollow structure may be rectangular or diamond-shaped, and the dimension of the longest side of the hollow structure is not greater than the width of the connecting rib 122 a.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (12)

1. A conveyor, comprising:
an inner core assembly; and
the inner core assembly comprises an inner core assembly, the restraint member is rotatably arranged on the inner core assembly, the restraint member sequentially comprises a fixing ring, a connecting rib and a clamping section from a near end to a far end, two ends of the connecting rib are respectively connected with the fixing ring and the clamping section, the fixing ring is rotatably arranged on the inner core assembly, the clamping section has a contraction configuration and an expansion configuration, in the contraction configuration, the clamping section is used for clamping the near end of the blood flow guide support between the inner core assembly and the clamping section, the friction coefficient of the surface of the inner core assembly close to the clamping section is larger than that of the surface of the inner core assembly far away from the clamping section, and in the expansion configuration, the clamping section is separated from the blood flow guide support.
2. The conveyor according to claim 1, characterized in that the clamping section comprises a clamping piece and a woven mesh connected with the clamping piece, the woven mesh and the clamping piece are connected end to form a tubular structure, and a film coating layer is arranged on the woven mesh.
3. The conveyor according to claim 2, wherein said holding pieces and said woven mesh are plural, and said holding pieces and said woven mesh are alternately arranged.
4. A conveyor according to claim 3, characterised in that said gripping flaps are of a one-piece construction with said knitted mesh.
5. The conveyor according to claim 2, characterized in that a silica gel gasket is arranged on the surface of the clamping piece close to the inner core assembly, a gasket is arranged on the inner core assembly corresponding to the clamping piece, and the gasket is sleeved on the inner core assembly.
6. A conveyor according to claim 1, wherein said core assembly is provided with a first developer member located at a distal end of said gasket and a second developer member located at a proximal end of said gasket.
7. The conveyor of claim 2 wherein the surfaces of the gripping sheets remote from the core assembly are provided with a smooth layer.
8. A conveyor according to claim 1, characterized in that said fixed ring is a developing structure.
9. The conveyor of claim 1 wherein said inner core assembly includes a delivery guidewire and a pusher rod connected to said delivery guidewire, said constraint being rotatably disposed on said delivery guidewire.
10. Conveyor according to claim 1, characterized in that the connecting ribs are provided with a hollow structure.
11. A blood flow guiding stent system comprising a blood flow guiding stent, characterized by comprising the delivery device of any one of claims 1 to 11, wherein the blood flow guiding stent is sleeved on the inner core assembly, and the proximal end of the blood flow guiding stent is constrained between the constraining member and the inner core assembly.
12. The blood flow directing stent system of claim 12, wherein the blood flow directing stent is woven from metal wires, the metal wires comprising an inner layer and an outer layer disposed on the inner layer, the inner layer being formed from a visualization material and the outer layer being formed from an elastic material.
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