WO2022253364A1 - Delivery guide wire and blood flow guiding apparatus - Google Patents

Delivery guide wire and blood flow guiding apparatus Download PDF

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Publication number
WO2022253364A1
WO2022253364A1 PCT/CN2022/113732 CN2022113732W WO2022253364A1 WO 2022253364 A1 WO2022253364 A1 WO 2022253364A1 CN 2022113732 W CN2022113732 W CN 2022113732W WO 2022253364 A1 WO2022253364 A1 WO 2022253364A1
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WO
WIPO (PCT)
Prior art keywords
guide wire
mandrel
delivery guide
wire according
friction pad
Prior art date
Application number
PCT/CN2022/113732
Other languages
French (fr)
Chinese (zh)
Inventor
曾凡艳
石华
贺心知
李志刚
王国辉
Original Assignee
上海心玮医疗科技股份有限公司
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Application filed by 上海心玮医疗科技股份有限公司 filed Critical 上海心玮医疗科技股份有限公司
Publication of WO2022253364A1 publication Critical patent/WO2022253364A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00862Material properties elastic or resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00902Material properties transparent or translucent
    • A61B2017/00915Material properties transparent or translucent for radioactive radiation
    • A61B2017/0092Material properties transparent or translucent for radioactive radiation for X-rays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0061Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • Embodiments of the present disclosure relate to the field of medical equipment, and in particular, to a delivery guide wire and a blood flow guiding device.
  • the treatment of intracranial aneurysms has gone through the development stages of early coil packing, balloon-assisted coil packing, and mid-term stent-assisted coil packing.
  • blood flow guiding devices are widely used for the treatment of intracranial aneurysms.
  • the design of the current blood flow guiding devices adopts the method of braiding filaments, so it has a high metal coverage, so that it can be placed at the position of the aneurysm.
  • the woven mesh intercepts the blood flow, changes the direction of the blood flow, guides the blood flow to flow in the direction of the stent guide, and prevents the blood flow from continuing to wash into the aneurysm, but it will further thin the blood vessel wall , increasing the risk of rupture
  • the angle of the distal end of the delivery guide wire is too small.
  • the doctor's limited attention is mainly focused on the release, deployment and apposition of the stent.
  • the tortuous blood vessel or obstacle is encountered, but the operator does not notice it, and keeps pushing the guide wire.
  • the distal end of the nearly straight delivery guide wire has the risk of puncturing the blood vessel.
  • the blood vessel bleeds after being punctured by the guide wire, resulting in cerebral hemorrhage. Since the bleeding point is at the distal end of the intracranial blood vessel, neither the microguide wire nor the coil can be put in place and cannot be remedied, so this bleeding is fatal;
  • both ends of the dense-mesh stent are open (the braided mesh is cut to form a broken end), and no new development point design is added at both ends, the delivery of the stent mainly depends on the design of the delivery guide wire. There are two main points in the design of the delivery guide wire. First, the distal end of the stent is wrapped, and a friction pad is designed at the proximal end.
  • the friction pad is inside the stent to stretch the stent so that it fits the inner wall of the delivery catheter, which reduces the risk of stent
  • the frictional force at the distal end increases the forward pushing force of the stent, and at the same time, because the distal end of the stent is wrapped, the stent is not easy to slip during the forward pushing process.
  • the wrapping design of the distal end also has the problem that the stent cannot be opened in the tortuous blood vessel. If the wrapping at the distal end of the stent cannot be opened, the guide wire cannot be withdrawn from the blood vessel, even if the stent and guide wire are recovered Access to the sheath is also difficult, which will bog down the clinician and take a lot of time to solve this difficult problem.
  • the distal end of the delivery guide wire does not wrap the stent, and multiple friction pads are designed at the proximal end of the stent to further increase the fit between the stent and the inner wall of the delivery catheter. This fit enables the stent to be pushed forward from the microcatheter.
  • This design avoids the problem that the distal end of the stent cannot be opened in some special blood vessels due to being wrapped, but there is a large gap between the distal end of the stent and the distal end of the guide wire (in order to increase the flexibility of the distal end of the delivery guide wire , usually as thin as a nerve microguide wire), the existence of the gap will cause the dense mesh stent to be pushed forward in the microcatheter, the stent will bend as a whole, and there will always be a tendency to move backwards, and the pushing force of the stent comes entirely from the stent near the stent.
  • the support force of the end friction pad will cause the braided wire at the proximal part of the stent to bear too much force, and these forces will be transmitted forward, which will make the whole stent receive uneven force.
  • the external performance is the push of the stent in the microcatheter The force increases, and even after the stent is pushed for a certain stroke, the stent and the friction pad are relatively displaced (the stent moves to the proximal end of the delivery guide wire), and after the stent is released, the distal end of the stent is prone to insufficient opening, or the proximal end of the stent is not fully opened, or even Insufficient simultaneous proximal and distal opening;
  • the length of the long specification support is greater than 40mm, and the span on the conveying guide wire is large. If the force is uneven during the conveying process, it is easy to cause uneven distribution of the braided wire In some cases, the uneven distribution of the braided filaments will lead to insufficient release and deployment of the stent, or poor adhesion to the wall, bending and discounting and other problems.
  • embodiments of the present disclosure provide a delivery guide wire and a blood flow guiding device to solve the problems in the prior art.
  • a delivery guide wire including a crimping section and a developing section that are continuously formed, and the crimping section includes a bendable mandrel. At least one flexible friction pad is arranged near its proximal end, and at least one expansion body is arranged near the distal end of the mandrel, and the expansion body has a diameter along the radial direction of the mandrel.
  • the end of the expansion body close to the friction pad is fixedly connected to the mandrel in the axial direction, the end of the expansion body away from the friction pad is connected to the
  • the mandrels are slidably connected in the axial direction, and at least one protective body is arranged at the proximal end of the developing section.
  • the mandrel is a tubular structure with a fixed extension length or a telescoping tubular structure.
  • the friction pad is arranged on the mandrel, its relative position with the mandrel is fixed in the axial direction, and it rotates around the mandrel in the radial direction of the mandrel 11 or is opposite to the mandrel.
  • the mandrel is fixed.
  • the friction pad is fixed on the mandrel in a wrapping manner or a multi-turn coil spring is arranged around the mandrel, and the friction pad is fixed on the coil spring.
  • the coil spring is made of platinum-iridium alloy.
  • multiple friction pads are sequentially arranged on the mandrel.
  • the friction pad adopts at least one structure among cylinder, spindle and sphere.
  • the friction pad is made of polymer material.
  • the polymer material is TPU material or silicone material.
  • the number of the expansion bodies is multiple, and the plurality of expansion bodies are arranged sequentially on the mandrel near its distal end.
  • the expansion body adopts a metal cage structure.
  • the expansion body adopts a polymer elastic body with a hollow structure, and the polymer elastic body is arranged as a single-layer porous structure.
  • the expansion body when adopts the structure of a metal cage, it has interconnected branches, and the developing material is disposed on the branches.
  • the developing material is at least one of platinum-iridium alloy, platinum-tungsten alloy, gold, and tantalum alloy.
  • the shape of the developing material is at least one of sheet shape, filament shape and ring shape.
  • the mounting method of the developing material on the branch adopts at least one of inlay, winding, and ring.
  • the distal end of the developing section is configured as an arc structure, and the arc structure is a U-shaped structure or a J-shaped structure.
  • the shape of the protective body is at least one of a sphere, an ellipsoid, or a cone.
  • the material of the protective body is one of tin, UV glue, high molecular polymer, and developable alloy material.
  • a first protective body and a second protective body are arranged near the developing section, the first protective body is arranged away from the crimping section, and the second protective body is close to the crimping section segment settings.
  • An embodiment of the present disclosure also provides a blood flow guiding device, which includes an introduction sheath, a stent, and the delivery guide wire according to any one of the above claims, the delivery guide wire is set in the introduction sheath, and The stent can be disposed within the delivery guidewire.
  • the embodiments of the present disclosure can be used in the blood flow guiding device, not only can maintain good flexibility and blood vessel super-selection performance, but also can deliver the stent to a designated position in the patient's blood vessel according to different usage scenarios.
  • FIG. 1 is a schematic structural view of a delivery guide wire according to an embodiment of the present disclosure
  • Fig. 2 is a structural schematic diagram of a delivery guide wire according to an embodiment of the present disclosure
  • FIG. 3 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure.
  • FIG. 4 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure.
  • FIG. 5 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure.
  • FIG. 6 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure.
  • FIG. 7 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure.
  • the first embodiment of the present disclosure provides a delivery guide wire.
  • the delivery guide wire here is suitable for use in a blood flow guiding device.
  • the tube is inserted into the patient's body, and then the introduction sheath is extended into the blood vessel of the patient and the medical implant such as a stent set in the delivery guide wire is delivered to a predetermined position in the patient's body.
  • the delivery guide wire includes a continuously formed crimping section 1 and a developing section 2, the crimping section 1 includes a mandrel 11, the mandrel 11 is a bendable tubular structure, the core
  • the interior of the shaft 11 is used to pass through, for example, a bracket, wherein the mandrel 11 here has a proximal end and a distal end, the proximal end refers to the end of the mandrel 11 away from the developing section 2, It refers to a position close to operators such as doctors.
  • the proximal end of the mandrel 11 can be connected with an operating handle, for example, to facilitate operations by operators such as doctors.
  • the distal end refers to the position of the mandrel. In 11, the end near the developing section 2 refers to a position close to the operating position for the patient, so that the developing section 2 is arranged outside the distal end of the mandrel 11, and It is fixedly connected with the crimping section 1 .
  • the mandrel 11 has a fixed extension length, and the extension length here can be determined according to the distance of the patient's operating position, so that it is not affected by the crimping of the stent on the guide wire. Instead, there is a variation in length, and moreover, the cross-sectional dimensions at any position along the extended length of the mandrel 11 are the same.
  • the mandrel 11 in order to be able to adjust the extension length of the mandrel 11 according to different patients, can adopt a retractable tubular structure, for example, a plurality of tubular structures are nested to form the core shaft 11, which can facilitate the adjustment of the extension length of the mandrel 11, so as to be used in different patients or in more operation scenarios.
  • a retractable tubular structure for example, a plurality of tubular structures are nested to form the core shaft 11, which can facilitate the adjustment of the extension length of the mandrel 11, so as to be used in different patients or in more operation scenarios.
  • At least one flexible friction pad 12 is arranged on the mandrel 11 near the proximal end, the friction pad 12 is arranged on the mandrel 11, and it is coaxial with the mandrel 11
  • the upward relative position is fixed, and can rotate around the mandrel 11 in the radial direction of the mandrel 11 or be fixed relative to the mandrel 11; the friction pad 12 here has a certain thickness, and it is used when the After the delivery guide wire is inserted into the patient's blood vessel, friction force can be formed with the blood vessel wall through the friction pad 12, and the delivery guide wire can be fixed in the blood vessel under the action of the friction force.
  • the way of fixing the friction pad 12 on the mandrel 11 can be in any way, for example, in a preferred embodiment, the friction pad 12 can be fixed on the mandrel in a wrapping manner. 11; in another preferred embodiment, on the mandrel 11, a multi-turn coil spring is arranged around the mandrel 11, and the friction pad 12 is fixed on the coil spring; in addition, the coil spring here can be, for example, Made of platinum-iridium alloy.
  • the mandrel 11 in order to increase the friction between the delivery guide wire and the blood vessel wall of the human body, thereby improving the fixing effect of the delivery guide wire in the blood vessel, the mandrel 11 can A plurality of said friction pads 12 are arranged on it.
  • the number of the friction pads 12 is multiple, multiple friction pads 12 can be arranged on the mandrel 11 in turn.
  • the number of the friction pads 12 is generally selected as 2-5. , for example, 3 can be selected.
  • the friction pad 12 can adopt a variety of structures with a certain thickness such as cylinders, spindles, and spheres that will not damage the blood vessels, so as to form a frictional force with the blood vessel walls of the blood vessels to fix the delivery. guide wire.
  • the friction pad 12 can be made of elastic material;
  • the pad 12 is made of polymer material, for example, any one of TPU (thermoplastic polyurethane elastomer rubber) material, silicone material and the like can be used.
  • the friction pad 12 here can be made of a single-layer structure using the same material, or a double-layer structure can be made of different materials, so that the inside maintains a certain hardness, while the outside has a certain flexibility, wherein the friction pad
  • the hardness of the inner structure of the friction pad 12 close to the mandrel 11 is greater than the hardness of the outer structure of the friction pad 12 away from the mandrel 11, where the inner structure and the outer structure are axially , circumferentially and radially are fixedly connected to each other.
  • At least one expansion body 13 is provided on the mandrel 11 close to the distal end.
  • the expansion body 13 is arranged outside the mandrel 11 , and the bracket is located inside the mandrel 11 .
  • the expansion body 13 is used to expand at a predetermined position in the blood vessel to expand the blood vessel, and the end of the expansion body 13 close to the friction pad 12 and the core shaft 11 are axially fixed connection, the end of the expansion body 13 away from the friction pad 12 is slidably connected to the mandrel 11 in the axial direction.
  • the fixing method between the expansion body 13 and the mandrel 11 can be adhesive connection, welding, or physical kneading or pressing; as a preferred method, adhesive bonding is adopted. .
  • the expansion body 13 here has scalability, that is, the outward expansion ability and elastic support force along the radial direction of the mandrel 11, so that the expansion body 13 can present Smaller volume, in other usage scenarios, the volume can be automatically increased, so that the volume can be changed according to different usage scenarios.
  • the expansion body when the stent is loaded in the delivery guide wire and the introduction sheath, the expansion body also shrinks and becomes thinner, and is distributed inside the stent, providing a uniform support force outward, so that the stent is evenly stressed, does not move, and does not twist.
  • the expansion body 13 on the delivery guide wire Since the expanded diameter of the expansion body 13 on the delivery guide wire is slightly larger than the inner diameter of the target blood vessel, the expansion body 13 on the delivery guide wire is first set to a compressed deformation state, and the delivery guide wire The wire goes deep into the introduction sheath. At this time, the expansion body 13 becomes thinner and longer when the delivery guidewire is accommodated in the introduction sheath. When the sheath is released in the patient's blood vessel, the delivery guidewire The expansion body 13 will expand automatically, thereby becoming thicker and shorter.
  • the mandrel 11 located in the inner layer realizes the flexibility of the delivery guide wire and the function of super-selecting blood vessels; the expansion body of the outer layer 13 Realize uniform stress during the stent delivery process, while not affecting or minimizing the impact on the flexibility and super-selection performance of the delivery guide wire, and not affecting the release and recovery of the delivery guide wire in the blood vessel.
  • the positions close to the distal end are arranged in sequence, and the plurality of expansion bodies 13 here can be arranged independently of each other or connected to each other.
  • the expansion body 13 has the ability to expand outwards along the radial direction of the mandrel 11.
  • the expansion body 13 can be made of nickel-titanium alloy-based material, for example.
  • the structure of the metal cage, in the production process, can form multiple branches by cutting and heat-treating the pipe made of nickel-titanium alloy, and then weave the multiple branches into a network structure by splicing. , thus cooling and shaping into a cage structure.
  • the network structure of the expansion body 13 will not overlap with the braided wire of the stent inside the mandrel 11 .
  • the expansion body 13 may be a polymer elastomer with a hollow structure.
  • the polymeric elastomer here is arranged as a single-layer porous structure, and several through holes are evenly distributed on the surface of the polymeric elastomer.
  • the polymer elastic body can present an ellipsoid-like structure in a natural expansion state, and in the state of being pressed by the outside world, the air or liquid inside it is evacuated to be in a compressed state, so that it can be worn It is retracted into the sheath to support the stent, and at the same time, the resistance of the stent to be pushed is increased due to the existence of friction.
  • the expansion body 13 when it adopts a structure such as a metal cage, it has interconnected branches 131, and a developing material 132 is arranged on the branches 131 of the expansion body 13, here
  • the developing material 132 can be selected from at least one of platinum-iridium alloy, platinum-tungsten alloy, gold, and tantalum alloy; the shape of the developing material 132 can be at least one of sheet shape, wire shape, ring shape, etc.; Corresponding to the different shapes of the developing material, the mounting method of the developing material 132 on the branch 131 may be one of wire wrapping, pressing ring and inlaying.
  • the shape of the developing material 132 can be set as a sheet.
  • the developing material 132 can be set in a mosaic manner, for example.
  • a hollow ring can be formed on the branches of the expansion body 13 by, for example, cutting, and the developing material, for example, in the form of a sheet 132 is embedded in this hollow ring, so that the developing material 132 in the form of a sheet with a slightly larger area can be stably fixed on the branches;
  • the material 132 is arranged on the branches of the expansion body 13 .
  • the developing material 132 may adopt a filamentary structure.
  • the developing material 132 may be installed in a wire-wrapped manner so that the developing material 132 It is fixed on the branch of the expansion body 13.
  • a thin neck section is formed on the branch of the expansion body 13 by, for example, cutting, and the filamentous developing material 132 is placed on the branch.
  • the thin neck section of the stem is wound into a spring shape, so that the developing material 132 can be installed on the branches; because in the structure of the metal cage, there are raised steps at both ends of each branch,
  • the step can limit the spring-shaped developing material 132 to prevent the developing material 132 from being displaced.
  • the developing material 132 can adopt a ring-shaped structure, and for the ring-shaped structure, the developing material 132 can be installed in a ring-shaped manner so that the developing material 132 It is fixed on the branch of the expansion body 13.
  • a thin neck section is formed on the branch of the expansion body 13 by, for example, cutting, and the ring-shaped developing material 132 is sleeved on the branch.
  • the step can limit the ring-shaped developing material 132 to prevent the developing material 132 from being displaced.
  • the distal end of the imaging section can be linear, which is suitable for tortuous blood vessels at the distal end of the aneurysm, or the special anatomical structure does not have a suitable position, as shown in Figure 3, in some embodiments, the imaging The distal end of the segment 2 is set in an arc structure, and the angle of the arc structure can be, for example, a 180° U-shaped structure or a J-shaped structure, so that the delivery guide wire in this embodiment is at the distal end of the patient's blood vessel. In the process of continuous delivery, even if a tortuous blood vessel or an obstacle is encountered, the blood vessel will not be punctured and cause the patient to bleed.
  • At least one protective body is arranged at the proximal end of the developing section 2, and the shape of the protective body is set as at least one of a sphere, an ellipsoid or a cone, and the material of the protective body is tin, UV glue, One of high molecular polymer and developable alloy materials.
  • two protective bodies are provided at the proximal end of the developing section 2, which are respectively a first protective body 211 and a second protective body 212, wherein the first protective body here is A protective body 211 is set away from the crimping section 1, and the second protective body 212 is set close to the crimping section 1,
  • the function of the first protective body 211 is that when the delivery guide wire is pushed or withdrawn in the blood vessel, when encountering a tortuous blood vessel, the diameter of the first protective body 211 is slightly larger than the delivery guide wire
  • the outer diameter of the distal end can make the delivery guide wire not close to the blood vessel wall due to the diameter factor of the first protective body, so that it is not easy to get stuck in the blood vessel; the second protective body 212 here
  • the function is to prevent the stent from being stuck or caught on the braided wire of the stent when the guide wire is retracted into the sheath tube when it rubs against the distal end of the stent, so as to prevent the stent from being driven during the recovery process, causing the stent to Displacement, or deformation of the distal port of the stent, or even shrinkage, causing vascular occlusion.
  • the second embodiment of the present disclosure provides a blood flow guiding device, which includes an introduction sheath, a stent, and the delivery guide wire in any one of the above-mentioned embodiments, and the delivery guide wire is set in the introduction sheath , the stent can be arranged in the delivery guidewire, especially in the mandrel 11 of the delivery guidewire.
  • the embodiments of the present disclosure can be used in the blood flow guiding device, not only can maintain good flexibility and blood vessel super-selection performance, but also can deliver the stent to a designated position in the patient's blood vessel according to different usage scenarios.

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Abstract

A delivery guide wire and a blood flow guiding apparatus. The delivery guide wire comprises a pressing and holding section (1) and a developing section (2) which are formed continuously. The pressing and holding section (1) comprises a bendable mandrel (11). At least one flexible friction pad (12) is provided at a position near the proximal end portion of the mandrel (11), and at least one expansion body (13) is provided at a position near the distal end portion of the mandrel (11). The expansion body (13) has, along the radial direction of the mandrel (11), the ability to automatically expand outward. The mandrel (11) and the end portion of the expansion body (13) near the friction pad (12) are fixedly connected on the axial direction. The mandrel (11) and the end portion of the expansion body (13) far away from the friction pad (12) are slidably connected on the axial direction. At least one protective body (211, 212) is provided at the proximal end of the developing section (2). The delivery guide wire can be used in the blood flow guiding apparatus. Thus, good flexibility and blood vessel super-selection performance can be maintained, and a stent can be delivered, according to different usage scenarios, to a designated position in the blood vessels of a patient.

Description

一种输送导丝以及血流导向装置A delivery guide wire and blood flow guiding device 技术领域technical field
本公开实施例涉及医疗设备领域,尤其涉及一种输送导丝以及血流导向装置。Embodiments of the present disclosure relate to the field of medical equipment, and in particular, to a delivery guide wire and a blood flow guiding device.
背景技术Background technique
颅内动脉瘤的治疗,经历了早期的弹簧圈填塞、球囊辅助弹簧圈填塞以及中期的支架辅助弹簧圈填塞等发展阶段。目前,广泛采用血流导向装置以用于颅内动脉瘤的治疗,现在的血流导向装置在设计上采用细丝编织的方式,为此具有较高的金属覆盖率,从而可以在动脉瘤位置的血管里均匀铺开,编织网拦截血流,改变血流冲刷的方向,引导血流按照支架导流的方向流动,避免血流继续向动脉瘤瘤体内冲刷,但是会使血管壁进一步变薄,增加破裂的风险The treatment of intracranial aneurysms has gone through the development stages of early coil packing, balloon-assisted coil packing, and mid-term stent-assisted coil packing. At present, blood flow guiding devices are widely used for the treatment of intracranial aneurysms. The design of the current blood flow guiding devices adopts the method of braiding filaments, so it has a high metal coverage, so that it can be placed at the position of the aneurysm. Spread evenly in the blood vessels of the aneurysm, the woven mesh intercepts the blood flow, changes the direction of the blood flow, guides the blood flow to flow in the direction of the stent guide, and prevents the blood flow from continuing to wash into the aneurysm, but it will further thin the blood vessel wall , increasing the risk of rupture
目前的血流导向装置普遍存在以下缺点:Current blood flow diversion devices generally have the following disadvantages:
(1)输送导丝的远端角度太小,在操作过程中,医生有限的注意力主要集中在支架的释放、展开和贴壁上,输送导丝远端的角度接近平直,在不断往远端推送的过程中,遇到迂曲的血管或者障碍物阻挡,而操作人员未注意到,并不停镶嵌推送导丝,接近平直的输送导丝远端有刺破血管的风险,远端血管被导丝刺破后出血,导致脑溢血。由于出血点在颅内血管的远端,微导丝和弹簧圈都不能到位,不能补救,因此这种出血是致命的;(1) The angle of the distal end of the delivery guide wire is too small. During the operation, the doctor's limited attention is mainly focused on the release, deployment and apposition of the stent. In the process of pushing the distal end, the tortuous blood vessel or obstacle is encountered, but the operator does not notice it, and keeps pushing the guide wire. The distal end of the nearly straight delivery guide wire has the risk of puncturing the blood vessel. The blood vessel bleeds after being punctured by the guide wire, resulting in cerebral hemorrhage. Since the bleeding point is at the distal end of the intracranial blood vessel, neither the microguide wire nor the coil can be put in place and cannot be remedied, so this bleeding is fatal;
(2)密网支架如果两端都是开放设计(编织网剪断形成断端),且两端没有增加新的显影点设计,支架的输送主要依靠输送导丝的设计。输送导丝的设计主要有2点,第一、将支架的远端包裹,近端设计摩擦垫,摩擦垫在支架内部,将支架撑开,使之与输送导管内壁贴合,这样既减少支架远端的摩擦力,又增加了支架向前的推送力,同时由于支架远端被包裹,支架在向前推送的过程中也不容易滑移。远端的包裹设计也存在使支架在迂曲血管内打不开的问题,如果支架远端的包裹物打不开,那么导丝也不能从血管内撤出,即使想将支架和导丝重新回收进入鞘管,也困难重重,这将会使临床医生陷入困境,需要花大量的时间来解决这个棘手的问题。并且也不总是能够 得到妥善的解决;第二、输送导丝的远端不包裹支架,在支架的近端设计多个摩擦垫,进一步增加支架和输送导管内壁之间的贴合,通过增加这种贴合力,使支架能够从微导管内向前推送。这种设计避免了支架远端因为被包裹,在某些特殊血管内打不开的问题,不过支架远端和导丝远端之间有较大的间隙(输送导丝远端为了增加柔顺性,通常像神经微导丝一样细),间隙的存在会使密网支架在微导管内向前推送时,支架整体弯曲,并始终存在向后移位的趋势,支架的推送力完全来自于支架近端摩擦垫的支撑力,会使得支架近端部分的编织丝承受的力偏大,并且这些力要向前传送,会使得整个支架受力不均匀,对外的表现是支架在微导管里的推送力增加,甚至支架推送一段行程后支架与摩擦垫相对移位(支架向输送导丝的近端移动),并且支架释放后容易出现支架远端打开不充分,或者支架近端打开不充分,甚至近端和远端同时打开不充分;(2) If both ends of the dense-mesh stent are open (the braided mesh is cut to form a broken end), and no new development point design is added at both ends, the delivery of the stent mainly depends on the design of the delivery guide wire. There are two main points in the design of the delivery guide wire. First, the distal end of the stent is wrapped, and a friction pad is designed at the proximal end. The friction pad is inside the stent to stretch the stent so that it fits the inner wall of the delivery catheter, which reduces the risk of stent The frictional force at the distal end increases the forward pushing force of the stent, and at the same time, because the distal end of the stent is wrapped, the stent is not easy to slip during the forward pushing process. The wrapping design of the distal end also has the problem that the stent cannot be opened in the tortuous blood vessel. If the wrapping at the distal end of the stent cannot be opened, the guide wire cannot be withdrawn from the blood vessel, even if the stent and guide wire are recovered Access to the sheath is also difficult, which will bog down the clinician and take a lot of time to solve this difficult problem. And it is not always able to be properly solved; second, the distal end of the delivery guide wire does not wrap the stent, and multiple friction pads are designed at the proximal end of the stent to further increase the fit between the stent and the inner wall of the delivery catheter. This fit enables the stent to be pushed forward from the microcatheter. This design avoids the problem that the distal end of the stent cannot be opened in some special blood vessels due to being wrapped, but there is a large gap between the distal end of the stent and the distal end of the guide wire (in order to increase the flexibility of the distal end of the delivery guide wire , usually as thin as a nerve microguide wire), the existence of the gap will cause the dense mesh stent to be pushed forward in the microcatheter, the stent will bend as a whole, and there will always be a tendency to move backwards, and the pushing force of the stent comes entirely from the stent near the stent. The support force of the end friction pad will cause the braided wire at the proximal part of the stent to bear too much force, and these forces will be transmitted forward, which will make the whole stent receive uneven force. The external performance is the push of the stent in the microcatheter The force increases, and even after the stent is pushed for a certain stroke, the stent and the friction pad are relatively displaced (the stent moves to the proximal end of the delivery guide wire), and after the stent is released, the distal end of the stent is prone to insufficient opening, or the proximal end of the stent is not fully opened, or even Insufficient simultaneous proximal and distal opening;
(3)密网支架因为型号规格较多,长规格的支架的长度大于40mm,在输送导丝上的跨度大,在输送的过程中如果受力不均匀,就很容易发生编织丝分布不均匀的情况,编织丝分布不均则会导致支架释放展开不充分,或者贴壁不良,弯曲打折等问题。(3) Due to the large number of models and specifications of the dense mesh support, the length of the long specification support is greater than 40mm, and the span on the conveying guide wire is large. If the force is uneven during the conveying process, it is easy to cause uneven distribution of the braided wire In some cases, the uneven distribution of the braided filaments will lead to insufficient release and deployment of the stent, or poor adhesion to the wall, bending and discounting and other problems.
发明内容Contents of the invention
有鉴于现有技术中存在的上述问题,本公开实施例提供了一种输送导丝以及血流导向装置,用以解决现有技术中存在的问题。In view of the above-mentioned problems in the prior art, embodiments of the present disclosure provide a delivery guide wire and a blood flow guiding device to solve the problems in the prior art.
为解决上述问题,本公开实施例提供的技术方案是:一种输送导丝,包括连续形成的压握段和显影段,所述压握段包括可弯曲的芯轴,在所述芯轴的靠近其近端部的位置设置至少一个柔性的摩擦垫,在所述芯轴的靠近其远端部的位置设置至少一个膨胀体,所述膨胀体具有沿所述芯轴的径向方向上的向外自动膨胀的能力,所述膨胀体的靠近所述摩擦垫的端部与所述芯轴之间在轴向上固定连接,所述膨胀体的远离所述摩擦垫的端部与所述芯轴之间在轴向上滑动连接,在所述显影段的近端设置至少一个保护体。In order to solve the above problems, the technical solution provided by the embodiments of the present disclosure is: a delivery guide wire, including a crimping section and a developing section that are continuously formed, and the crimping section includes a bendable mandrel. At least one flexible friction pad is arranged near its proximal end, and at least one expansion body is arranged near the distal end of the mandrel, and the expansion body has a diameter along the radial direction of the mandrel. The ability to self-expand outwards, the end of the expansion body close to the friction pad is fixedly connected to the mandrel in the axial direction, the end of the expansion body away from the friction pad is connected to the The mandrels are slidably connected in the axial direction, and at least one protective body is arranged at the proximal end of the developing section.
在一些实施例中,所述芯轴为具有固定延伸长度的管状结构或者为可伸缩的管状结构。In some embodiments, the mandrel is a tubular structure with a fixed extension length or a telescoping tubular structure.
在一些实施例中,所述摩擦垫设置在所述芯轴上,其与所述芯轴在轴向上的相对位置固定,在所述芯轴11的径向上绕所述芯轴转动或者相对所述芯轴固定。In some embodiments, the friction pad is arranged on the mandrel, its relative position with the mandrel is fixed in the axial direction, and it rotates around the mandrel in the radial direction of the mandrel 11 or is opposite to the mandrel. The mandrel is fixed.
在一些实施例中,所述摩擦垫以环绕包裹的方式固定在所述芯轴上或者在所述芯轴上环绕设置多圈的绕簧,所述摩擦垫固定在所述绕簧上。In some embodiments, the friction pad is fixed on the mandrel in a wrapping manner or a multi-turn coil spring is arranged around the mandrel, and the friction pad is fixed on the coil spring.
在一些实施例中,所述绕簧采用铂-铱合金制成。In some embodiments, the coil spring is made of platinum-iridium alloy.
在一些实施例中,当所述摩擦垫的数量为多个时,多个所述摩擦垫依次在所述芯轴上布置。In some embodiments, when there are multiple friction pads, multiple friction pads are sequentially arranged on the mandrel.
在一些实施例中,所述摩擦垫采用圆柱体、纺锤体、球体中的至少一种结构。In some embodiments, the friction pad adopts at least one structure among cylinder, spindle and sphere.
在一些实施例中,所述摩擦垫采用聚合物材料制成。In some embodiments, the friction pad is made of polymer material.
在一些实施例中,所述聚合物材料为TPU材料或者硅胶材料。In some embodiments, the polymer material is TPU material or silicone material.
在一些实施例中,所述膨胀体的数量是多个,多个所述膨胀体在所述芯轴上靠近其远端部的位置依次布置。In some embodiments, the number of the expansion bodies is multiple, and the plurality of expansion bodies are arranged sequentially on the mandrel near its distal end.
在一些实施例中,所述膨胀体采用金属笼的结构。In some embodiments, the expansion body adopts a metal cage structure.
在一些实施例中,所述膨胀体采用具有中空结构的聚合物弹性体,所述聚合物弹性体设置为单层多孔结构。In some embodiments, the expansion body adopts a polymer elastic body with a hollow structure, and the polymer elastic body is arranged as a single-layer porous structure.
在一些实施例中,当所述膨胀体采用金属笼的结构时,其具有相互连接的枝干,在所述枝干上设置显影材料。In some embodiments, when the expansion body adopts the structure of a metal cage, it has interconnected branches, and the developing material is disposed on the branches.
在一些实施例中,所述显影材料是铂铱合金、铂钨合金、黄金、钽合金中的至少一种。In some embodiments, the developing material is at least one of platinum-iridium alloy, platinum-tungsten alloy, gold, and tantalum alloy.
在一些实施例中,所述显影材料的形状是片状、丝状、环状中的至少一种。In some embodiments, the shape of the developing material is at least one of sheet shape, filament shape and ring shape.
在一些实施例中,所述显影材料在所述枝干上的安装方式根据所述显影材料的形状采用镶嵌、绕丝、套环中的至少一种。In some embodiments, according to the shape of the developing material, the mounting method of the developing material on the branch adopts at least one of inlay, winding, and ring.
在一些实施例中,所述显影段的远端设置为弧形结构,所述弧形结构是U形结构或者J形结构。In some embodiments, the distal end of the developing section is configured as an arc structure, and the arc structure is a U-shaped structure or a J-shaped structure.
在一些实施例中,所述保护体的形状设置为球体、椭球体或锥体中的至少一种。In some embodiments, the shape of the protective body is at least one of a sphere, an ellipsoid, or a cone.
在一些实施例中,所述保护体的材料采用锡、UV胶、高分子聚合物、可显影合金材料中的一种。In some embodiments, the material of the protective body is one of tin, UV glue, high molecular polymer, and developable alloy material.
在一些实施例中,在所述显影段的近端设置第一保护体和第二保护体,所述第一保护体远离所述压握段设置,所述第二保护体靠近所述压握段设置。In some embodiments, a first protective body and a second protective body are arranged near the developing section, the first protective body is arranged away from the crimping section, and the second protective body is close to the crimping section segment settings.
本公开实施例还提供一种血流导向装置,其包括导入鞘管、支架以及上 述任一项权利要求中的所述输送导丝,所述输送导丝设置在所述导入鞘管中,所述支架能够设置在所述输送导丝中。An embodiment of the present disclosure also provides a blood flow guiding device, which includes an introduction sheath, a stent, and the delivery guide wire according to any one of the above claims, the delivery guide wire is set in the introduction sheath, and The stent can be disposed within the delivery guidewire.
本公开实施例能够用于血流导向装置中,不但能够保持较好的柔顺性和血管超选的性能,还能够针对不同的使用场景将所述支架输送到患者血管中的指定位置。The embodiments of the present disclosure can be used in the blood flow guiding device, not only can maintain good flexibility and blood vessel super-selection performance, but also can deliver the stent to a designated position in the patient's blood vessel according to different usage scenarios.
附图说明Description of drawings
为了更清楚地说明本公开实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本公开中记载的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动性的前提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments described in the present disclosure. Those skilled in the art can also obtain other drawings based on these drawings without any creative effort.
图1为本公开的实施例的输送导丝的结构示意图;FIG. 1 is a schematic structural view of a delivery guide wire according to an embodiment of the present disclosure;
图2为本公开的实施例的输送导丝的结构示意图Fig. 2 is a structural schematic diagram of a delivery guide wire according to an embodiment of the present disclosure
图3为本公开的实施例的输送导丝的结构示意图;3 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure;
图4为本公开的实施例的输送导丝的结构示意图;4 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure;
图5为本公开的实施例的输送导丝的结构示意图;5 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure;
图6为本公开的实施例的输送导丝的结构示意图;6 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure;
图7为本公开的实施例的输送导丝的结构示意图。FIG. 7 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present disclosure.
具体实施方式Detailed ways
此处参考附图描述本申请的各种方案以及特征。Various aspects and features of the present application are described herein with reference to the accompanying drawings.
应理解的是,可以对此处申请的实施例做出各种修改。因此,上述说明书不应该视为限制,而仅是作为实施例的范例。本领域的技术人员将想到在本申请的范围和精神内的其他修改。It should be understood that various modifications may be made to the embodiments applied for herein. Accordingly, the above description should not be viewed as limiting, but only as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the application.
包含在说明书中并构成说明书的一部分的附图示出了本申请的实施例,并且与上面给出的对本申请的大致描述以及下面给出的对实施例的详细描述一起用于解释本申请的原理。The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the application and, together with the general description of the application given above and the detailed description of the embodiments given below, serve to explain the embodiments of the application. principle.
通过下面参照附图对给定为非限制性实例的实施例的优选形式的描述,本申请的这些和其它特性将会变得显而易见。These and other characteristics of the present application will become apparent from the following description of preferred forms of embodiment given as non-limiting examples with reference to the accompanying drawings.
还应当理解,尽管已经参照一些具体实例对本申请进行了描述,但本领域技术人员能够确定地实现本申请的很多其它等效形式。It should also be understood that, while the application has been described with reference to a few specific examples, those skilled in the art will be able to implement certain other equivalents of the application.
当结合附图时,鉴于以下详细说明,本申请的上述和其他方面、特征和优势将变得更为显而易见。The above and other aspects, features and advantages of the present application will become more apparent in view of the following detailed description when taken in conjunction with the accompanying drawings.
此后参照附图描述本申请的具体实施例;然而,应当理解,所申请的实施例仅仅是本申请的实例,其可采用多种方式实施。熟知和/或重复的功能和结构并未详细描述以避免不必要或多余的细节使得本申请模糊不清。因此,本文所申请的具体的结构性和功能性细节并非意在限定,而是仅仅作为权利要求的基础和代表性基础用于教导本领域技术人员以实质上任意合适的详细结构多样地使用本申请。Specific embodiments of the present application are hereinafter described with reference to the accompanying drawings; however, it should be understood that the applied embodiments are merely examples of the present application, which can be implemented in various ways. Well-known and/or repetitive functions and constructions are not described in detail to avoid obscuring the application with unnecessary or redundant detail. Therefore, specific structural and functional details disclosed herein are not intended to be limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any suitable detailed structure. Application.
本说明书可使用词组“在一种实施例中”、“在另一个实施例中”、“在又一实施例中”或“在其他实施例中”,其均可指代根据本申请的相同或不同实施例中的一个或多个。This specification may use the phrases "in one embodiment," "in another embodiment," "in yet another embodiment," or "in other embodiments," which may refer to the same or one or more of the different embodiments.
本公开的第一实施例提供一种输送导丝,这里的所述输送导丝适用于血流导向装置中,其能够在医生等操作人员的操作下首先设置在导入鞘管内并随着导入鞘管进入到患者的体内,然后伸出所述导入鞘管并进入到患者的血管中并将设置在所述输送导丝中的医用植入物例如支架输送至患者体内的预定位置。如图1所示,所述输送导丝包括连续形成的压握段1和显影段2,所述压握段1包括芯轴11,所述芯轴11为可弯曲的管状结构,所述芯轴11内部用于通过例如支架,其中,这里的所述芯轴11具有近端部和远端部,所述近端部是指所述芯轴11上远离所述显影段2的端部,其是指与医生等操作人员接近的位置,所述芯轴11的所述近端部例如可以与操作手柄相连接以便于医生等操作人员执行操作,所述远端部是指所述芯轴11中靠近所述显影段2的端部,其是指与针对患者的操作位置相接近的位置,这样,所述显影段2设置在所述芯轴11的所述远端部的外侧,并与所述压握段1之间固定连接。The first embodiment of the present disclosure provides a delivery guide wire. The delivery guide wire here is suitable for use in a blood flow guiding device. The tube is inserted into the patient's body, and then the introduction sheath is extended into the blood vessel of the patient and the medical implant such as a stent set in the delivery guide wire is delivered to a predetermined position in the patient's body. As shown in Figure 1, the delivery guide wire includes a continuously formed crimping section 1 and a developing section 2, the crimping section 1 includes a mandrel 11, the mandrel 11 is a bendable tubular structure, the core The interior of the shaft 11 is used to pass through, for example, a bracket, wherein the mandrel 11 here has a proximal end and a distal end, the proximal end refers to the end of the mandrel 11 away from the developing section 2, It refers to a position close to operators such as doctors. The proximal end of the mandrel 11 can be connected with an operating handle, for example, to facilitate operations by operators such as doctors. The distal end refers to the position of the mandrel. In 11, the end near the developing section 2 refers to a position close to the operating position for the patient, so that the developing section 2 is arranged outside the distal end of the mandrel 11, and It is fixedly connected with the crimping section 1 .
具体地,在一个优选的实施方式中,所述芯轴11具有固定的延伸长度,这里的延伸长度可以根据针对患者的操作位置的距离而确定,这样,不因支架在导丝上的压握而有长度变化,此外,在所述芯轴11的延伸长度上的任意位置处的截面尺寸相同。在另一个优选的实施方式中,为了能够根据不同患者调整所述芯轴11的延伸长度,所述芯轴11可以采用可伸缩的管状结构,例如采用多个管状结构相互套接形成所述芯轴11,这样能够便于调整所述芯 轴11的延伸长度,以便于运用于不同的患者或者运用在更多的操作场景下。Specifically, in a preferred embodiment, the mandrel 11 has a fixed extension length, and the extension length here can be determined according to the distance of the patient's operating position, so that it is not affected by the crimping of the stent on the guide wire. Instead, there is a variation in length, and moreover, the cross-sectional dimensions at any position along the extended length of the mandrel 11 are the same. In another preferred embodiment, in order to be able to adjust the extension length of the mandrel 11 according to different patients, the mandrel 11 can adopt a retractable tubular structure, for example, a plurality of tubular structures are nested to form the core shaft 11, which can facilitate the adjustment of the extension length of the mandrel 11, so as to be used in different patients or in more operation scenarios.
进一步地,在所述芯轴11上靠近所述近端部的位置设置至少一个柔性的摩擦垫12,所述摩擦垫12设置在所述芯轴11上,其与所述芯轴11在轴向上的相对位置固定,在所述芯轴11的径向上可以绕所述芯轴11转动或者相对所述芯轴11固定;这里的所述摩擦垫12具有一定的厚度,其用于当所述输送导丝伸入到患者的血管中后,可以通过所述摩擦垫12与血管壁形成摩擦力,在摩擦力的作用下以便于在所述血管中固定所述输送导丝。Further, at least one flexible friction pad 12 is arranged on the mandrel 11 near the proximal end, the friction pad 12 is arranged on the mandrel 11, and it is coaxial with the mandrel 11 The upward relative position is fixed, and can rotate around the mandrel 11 in the radial direction of the mandrel 11 or be fixed relative to the mandrel 11; the friction pad 12 here has a certain thickness, and it is used when the After the delivery guide wire is inserted into the patient's blood vessel, friction force can be formed with the blood vessel wall through the friction pad 12, and the delivery guide wire can be fixed in the blood vessel under the action of the friction force.
当然,这里的在所述芯轴11上固定所述摩擦垫12的方式可以采用任意方式,例如在一个优选的实施方式中,所述摩擦垫12可以以环绕包裹的方式固定在所述芯轴11上;在另一个优选的实施方式中,在所述芯轴11上环绕设置多圈的绕簧,所述摩擦垫12固定在所述绕簧上;此外,这里的所述绕簧例如可以采用铂-铱合金制成。Of course, the way of fixing the friction pad 12 on the mandrel 11 here can be in any way, for example, in a preferred embodiment, the friction pad 12 can be fixed on the mandrel in a wrapping manner. 11; in another preferred embodiment, on the mandrel 11, a multi-turn coil spring is arranged around the mandrel 11, and the friction pad 12 is fixed on the coil spring; in addition, the coil spring here can be, for example, Made of platinum-iridium alloy.
此外,如图2所示,为了增大所述输送导丝与人体的血管壁之间的摩擦力,从而提升所述输送导丝在所述血管中的固定效果,可以在所述芯轴11上设置多个所述摩擦垫12。当所述摩擦垫12的数量为多个时,多个所述摩擦垫12可以依次在所述芯轴11上布置,在本公开实施例中,所述摩擦垫12的数量一般选择2-5个,例如可以选择3个。In addition, as shown in FIG. 2 , in order to increase the friction between the delivery guide wire and the blood vessel wall of the human body, thereby improving the fixing effect of the delivery guide wire in the blood vessel, the mandrel 11 can A plurality of said friction pads 12 are arranged on it. When the number of the friction pads 12 is multiple, multiple friction pads 12 can be arranged on the mandrel 11 in turn. In the embodiment of the present disclosure, the number of the friction pads 12 is generally selected as 2-5. , for example, 3 can be selected.
进一步地,所述摩擦垫12可以采用圆柱体、纺锤体、球体等多种具有一定厚度并且不会损伤到血管的结构,以便与所述血管的血管壁之间形成摩擦力以固定所述输送导丝。为了能够在血管中固定所述输送导丝的作用并且不会损伤到血管壁,所述摩擦垫12可以采用弹性材料制成;优选地,考虑到对人体无害的原因,这里的所述摩擦垫12采用聚合物材料制成,例如可以采用TPU(热塑性聚氨酯弹性体橡胶)材料、硅胶材料等中的任意一种。Further, the friction pad 12 can adopt a variety of structures with a certain thickness such as cylinders, spindles, and spheres that will not damage the blood vessels, so as to form a frictional force with the blood vessel walls of the blood vessels to fix the delivery. guide wire. In order to be able to fix the function of the delivery guide wire in the blood vessel without damaging the blood vessel wall, the friction pad 12 can be made of elastic material; The pad 12 is made of polymer material, for example, any one of TPU (thermoplastic polyurethane elastomer rubber) material, silicone material and the like can be used.
这里的所述摩擦垫12可以采用相同材料制成单层结构,也可以采用不同的材料制成双层结构,以使得内部保持一定的硬度,而外部具有一定的柔性,其中,所述摩擦垫12的靠近所述芯轴11的内层结构的硬度大于所述摩擦垫12的远离所述芯轴11的外层结构的硬度,这里的所述内层结构和所述外层结构在轴向、周向、径向上相互之间为固定连接。The friction pad 12 here can be made of a single-layer structure using the same material, or a double-layer structure can be made of different materials, so that the inside maintains a certain hardness, while the outside has a certain flexibility, wherein the friction pad The hardness of the inner structure of the friction pad 12 close to the mandrel 11 is greater than the hardness of the outer structure of the friction pad 12 away from the mandrel 11, where the inner structure and the outer structure are axially , circumferentially and radially are fixedly connected to each other.
在所述芯轴11上靠近所述远端部的位置设置至少一个膨胀体13,需要说明的是,所述芯轴11上设置所述膨胀体13的位置为例如支架的装载段,这里所述膨胀体13设置在所述芯轴11的外部,所述支架位于所述芯轴11 的内部。其中,所述膨胀体13用于在血管中的预定位置发生膨胀以将血管扩张,所述膨胀体13的靠近所述摩擦垫12的端部与所述芯轴11之间在轴向上固定连接,所述膨胀体13的远离所述摩擦垫12的端部与所述芯轴11之间在轴向上滑动连接。其中,所述膨胀体13与所述芯轴11之间的固定方式可以是粘性连接,也可以是焊接,还可以是物理捏合或者压握的方式;作为优选的一种方式采用是粘性粘接。At least one expansion body 13 is provided on the mandrel 11 close to the distal end. It should be noted that the position where the expansion body 13 is provided on the mandrel 11 is, for example, the loading section of the stent. Here, The expansion body 13 is arranged outside the mandrel 11 , and the bracket is located inside the mandrel 11 . Wherein, the expansion body 13 is used to expand at a predetermined position in the blood vessel to expand the blood vessel, and the end of the expansion body 13 close to the friction pad 12 and the core shaft 11 are axially fixed connection, the end of the expansion body 13 away from the friction pad 12 is slidably connected to the mandrel 11 in the axial direction. Wherein, the fixing method between the expansion body 13 and the mandrel 11 can be adhesive connection, welding, or physical kneading or pressing; as a preferred method, adhesive bonding is adopted. .
进一步地,这里的所述膨胀体13具有可伸缩性,即沿所述芯轴11的径向方向上的向外膨胀能力以及弹性支撑力,从而所述膨胀体13能够在一些使用场景下呈现较小的体积,在另一些使用场景下实现体积的自动增大,从而能够根据使用场景的不同而实现体积的变化。具体地,支架装载在输送导丝和导入鞘中时,膨胀体也收缩变细边长,分布在支架的内部,均匀的向外提供支撑力,使支架均匀受力,不移动,不扭曲。Further, the expansion body 13 here has scalability, that is, the outward expansion ability and elastic support force along the radial direction of the mandrel 11, so that the expansion body 13 can present Smaller volume, in other usage scenarios, the volume can be automatically increased, so that the volume can be changed according to different usage scenarios. Specifically, when the stent is loaded in the delivery guide wire and the introduction sheath, the expansion body also shrinks and becomes thinner, and is distributed inside the stent, providing a uniform support force outward, so that the stent is evenly stressed, does not move, and does not twist.
由于所述输送导丝上的所述膨胀体13的膨胀后的直径略大于目标血管的内径,首先将所述输送导丝上的所述膨胀体13设置为压缩变形状态,并所述输送导丝深入到导入鞘管内,此时,所述膨胀体13在所述输送导丝收纳在导入鞘管中时变细变长,当在患者的血管内释放鞘管时,所述输送导丝上的所述膨胀体13将自动膨胀,从而变粗且变短。Since the expanded diameter of the expansion body 13 on the delivery guide wire is slightly larger than the inner diameter of the target blood vessel, the expansion body 13 on the delivery guide wire is first set to a compressed deformation state, and the delivery guide wire The wire goes deep into the introduction sheath. At this time, the expansion body 13 becomes thinner and longer when the delivery guidewire is accommodated in the introduction sheath. When the sheath is released in the patient's blood vessel, the delivery guidewire The expansion body 13 will expand automatically, thereby becoming thicker and shorter.
通过在所述芯轴11上设置所述膨胀体13,从而使得位于内层的所述芯轴11实现所述输送导丝的柔顺性,超选血管的功能;使得外层的所述膨胀体13实现支架输送过程中均匀受力,同时不影响或尽量小的影响输送导丝的柔顺性和超选性能,不影响输送导丝在血管内释放和回收。By setting the expansion body 13 on the mandrel 11, the mandrel 11 located in the inner layer realizes the flexibility of the delivery guide wire and the function of super-selecting blood vessels; the expansion body of the outer layer 13 Realize uniform stress during the stent delivery process, while not affecting or minimizing the impact on the flexibility and super-selection performance of the delivery guide wire, and not affecting the release and recovery of the delivery guide wire in the blood vessel.
进一步地,为了提升扩张血管的效果或者在多个预定位置扩张血管,如图2所示,所述膨胀体13的数量可以是多个,多个所述膨胀体13可以在所述芯轴11上靠近所述远端部的位置依次布置,这里的多个所述膨胀体13可以相互独立设置或相互连接。Further, in order to improve the effect of dilating blood vessels or to dilate blood vessels at multiple predetermined positions, as shown in FIG. The positions close to the distal end are arranged in sequence, and the plurality of expansion bodies 13 here can be arranged independently of each other or connected to each other.
如上所述,所述膨胀体13具有沿所述芯轴11的径向方向上的向外膨胀能力,为此,在一些实施例中,所述膨胀体13例如可以采用基于镍-钛合金材料的金属笼的结构,在制作过程中,可以通过将镍-钛合金合金制成的管材进行分段切割热处理而形成多个枝干,然后通过拼接的方式将多个枝干编织为网状结构,从而冷却定型为笼形结构。这里的所述膨胀体13的网状结构不会与所述芯轴11内部的例如所述支架的编制丝相互重叠影响。As mentioned above, the expansion body 13 has the ability to expand outwards along the radial direction of the mandrel 11. For this reason, in some embodiments, the expansion body 13 can be made of nickel-titanium alloy-based material, for example. The structure of the metal cage, in the production process, can form multiple branches by cutting and heat-treating the pipe made of nickel-titanium alloy, and then weave the multiple branches into a network structure by splicing. , thus cooling and shaping into a cage structure. Here, the network structure of the expansion body 13 will not overlap with the braided wire of the stent inside the mandrel 11 .
在另一些实施例中,所述膨胀体13可以采用具有中空结构的聚合物弹性体。这里的所述聚合物弹性体设置为单层多孔结构,在所述聚合物弹性体的表面均匀分布有若干通孔。其中,所述聚合物弹性体在自然的膨胀状态下可以呈现类似椭球型的结构,在通过外界压握的状态下,其内部的空气或液体被排空从而处于压缩状态,以便于能够穿过收进导入鞘管中,从而起到对支架的支撑作用,同时由于摩擦力的存在而增加支架推送的阻力。In some other embodiments, the expansion body 13 may be a polymer elastomer with a hollow structure. The polymeric elastomer here is arranged as a single-layer porous structure, and several through holes are evenly distributed on the surface of the polymeric elastomer. Wherein, the polymer elastic body can present an ellipsoid-like structure in a natural expansion state, and in the state of being pressed by the outside world, the air or liquid inside it is evacuated to be in a compressed state, so that it can be worn It is retracted into the sheath to support the stent, and at the same time, the resistance of the stent to be pushed is increased due to the existence of friction.
在另一个实施方式中,当所述膨胀体13采用例如金属笼的结构时,其具有相互连接的枝干131,在所述膨胀体13的所述枝干131上设置显影材料132,这里的所述显影材料132可以选自铂铱合金、铂钨合金、黄金、钽合金中的至少一种;所述显影材料132的形状可以采用片状、丝状、环状等中的至少一种;对应于不同形状的所述显影材料,所述显影材料132在所述枝干131上的安装方式可以是绕丝、压环、镶嵌中的一种。In another embodiment, when the expansion body 13 adopts a structure such as a metal cage, it has interconnected branches 131, and a developing material 132 is arranged on the branches 131 of the expansion body 13, here The developing material 132 can be selected from at least one of platinum-iridium alloy, platinum-tungsten alloy, gold, and tantalum alloy; the shape of the developing material 132 can be at least one of sheet shape, wire shape, ring shape, etc.; Corresponding to the different shapes of the developing material, the mounting method of the developing material 132 on the branch 131 may be one of wire wrapping, pressing ring and inlaying.
在一个实施方式中,如图5所示,所述显影材料132的形状可以设置为片材,当采用例如片状的所述显影材料132时,所述显影材料132可以通过例如镶嵌的方式设置在所述膨胀体13的枝干上,具体地,在制作时,可以在所述膨胀体13的枝干上通过例如切割的方式形成一个空心的圆环,将例如片状的所述显影材料132镶嵌在这个空心圆环中,这样能够将面积稍大的片状的所述显影材料132稳定固定在所述枝干上;当然也可以采用其他的设置方式以便于将片状的所述显影材料132设置在所述膨胀体13的枝干上。In one embodiment, as shown in FIG. 5 , the shape of the developing material 132 can be set as a sheet. When the developing material 132 is in the form of a sheet, for example, the developing material 132 can be set in a mosaic manner, for example. On the branches of the expansion body 13, specifically, during manufacture, a hollow ring can be formed on the branches of the expansion body 13 by, for example, cutting, and the developing material, for example, in the form of a sheet 132 is embedded in this hollow ring, so that the developing material 132 in the form of a sheet with a slightly larger area can be stably fixed on the branches; The material 132 is arranged on the branches of the expansion body 13 .
在另一个实施方式中,如图6所示,所述显影材料132可以采用丝状的结构,针对丝状结构,所述显影材料132在可以采用绕丝的安装方式以将所述显影材料132固定在所述膨胀体13的枝干上,在制作时,将所述膨胀体13的枝干上通过例如切割的方式形成一个细颈段,将丝状的所述显影材料132在所述枝干的细颈段绕制成簧状,从而能够将所述显影材料132安装在所述枝干上;由于在金属笼的结构中,每个所述枝干的两端有凸起的台阶,这里所述台阶能够对簧状的所述显影材料132实现限位以防止所述显影材料132发生移位的情况。In another embodiment, as shown in FIG. 6 , the developing material 132 may adopt a filamentary structure. For a filamentous structure, the developing material 132 may be installed in a wire-wrapped manner so that the developing material 132 It is fixed on the branch of the expansion body 13. During manufacture, a thin neck section is formed on the branch of the expansion body 13 by, for example, cutting, and the filamentous developing material 132 is placed on the branch. The thin neck section of the stem is wound into a spring shape, so that the developing material 132 can be installed on the branches; because in the structure of the metal cage, there are raised steps at both ends of each branch, Here, the step can limit the spring-shaped developing material 132 to prevent the developing material 132 from being displaced.
在另一个实施方式中,如图7所示,所述显影材料132可以采用环状的结构,针对环状结构,所述显影材料132在可以采用套环的安装方式以将所述显影材料132固定在所述膨胀体13的枝干上,在制作时,将所述膨胀体13的枝干上通过例如切割的方式形成一个细颈段,将环状的所述显影材料 132套设在所述枝干的细颈段上并压握,从而能够将所述显影材料132安装在所述枝干上;由于在金属笼的结构中,每个所述枝干的两端有凸起的台阶,这里所述台阶能够对环状的所述显影材料132实现限位以防止所述显影材料132发生移位的情况。In another embodiment, as shown in FIG. 7 , the developing material 132 can adopt a ring-shaped structure, and for the ring-shaped structure, the developing material 132 can be installed in a ring-shaped manner so that the developing material 132 It is fixed on the branch of the expansion body 13. During production, a thin neck section is formed on the branch of the expansion body 13 by, for example, cutting, and the ring-shaped developing material 132 is sleeved on the branch. On the thin neck section of the branch and press it, so that the developing material 132 can be installed on the branch; because in the structure of the metal cage, there are raised steps at both ends of each branch Here, the step can limit the ring-shaped developing material 132 to prevent the developing material 132 from being displaced.
一般上,所述显影段的远端可以为直线型,其适合用于动脉瘤远端血管迂曲,或者解剖结构特殊无合适的位置,如图3所示,在一些实施方式中,所述显影段2的远端设置为弧形结构,所述弧形结构的角度例如可以是180°的U形结构或者J形结构,这样,本实施例的所述输送导丝在向患者的血管远端不断输送的过程中,即使遇到迂曲的血管,或者遇到障碍物,也不会将血管捅破而导致患者发生出血的情况。Generally, the distal end of the imaging section can be linear, which is suitable for tortuous blood vessels at the distal end of the aneurysm, or the special anatomical structure does not have a suitable position, as shown in Figure 3, in some embodiments, the imaging The distal end of the segment 2 is set in an arc structure, and the angle of the arc structure can be, for example, a 180° U-shaped structure or a J-shaped structure, so that the delivery guide wire in this embodiment is at the distal end of the patient's blood vessel. In the process of continuous delivery, even if a tortuous blood vessel or an obstacle is encountered, the blood vessel will not be punctured and cause the patient to bleed.
此外,在所述显影段2的近端设置至少一个保护体,所述保护体的形状设置为球体、椭球体或锥体中的至少一种,所述保护体的材料为锡、UV胶、高分子聚合物、可显影合金材料中的一种。In addition, at least one protective body is arranged at the proximal end of the developing section 2, and the shape of the protective body is set as at least one of a sphere, an ellipsoid or a cone, and the material of the protective body is tin, UV glue, One of high molecular polymer and developable alloy materials.
在一个优选的实施方式中,如图4所示,在所述显影段2的近端设置两个保护体,分别是第一保护体211和第二保护体212,其中,这里的所述第一保护体211远离所述压握段1设置,所述第二保护体212靠近所述压握段1设置,In a preferred embodiment, as shown in FIG. 4, two protective bodies are provided at the proximal end of the developing section 2, which are respectively a first protective body 211 and a second protective body 212, wherein the first protective body here is A protective body 211 is set away from the crimping section 1, and the second protective body 212 is set close to the crimping section 1,
其中,所述第一保护体211的作用在当所述输送导丝在血管内推送或撤退时,在遇到迂曲的血管时,所述第一保护体211的直径稍大于所述输送导丝的远端的外径,可以使所述输送导丝因为所述第一保护体的直径因素而不会贴近血管壁,从而不容易在血管内卡顿;这里的所述第二保护体212的作用在于当所述输送导丝回收进导入鞘管的过程中,在与支架的远端产生摩擦时,避免卡住支架或者挂住支架的编织丝,防止在回收的过程中带动支架,导致支架移位,或者支架远端口变形,甚至是缩口,引起血管闭塞。Wherein, the function of the first protective body 211 is that when the delivery guide wire is pushed or withdrawn in the blood vessel, when encountering a tortuous blood vessel, the diameter of the first protective body 211 is slightly larger than the delivery guide wire The outer diameter of the distal end can make the delivery guide wire not close to the blood vessel wall due to the diameter factor of the first protective body, so that it is not easy to get stuck in the blood vessel; the second protective body 212 here The function is to prevent the stent from being stuck or caught on the braided wire of the stent when the guide wire is retracted into the sheath tube when it rubs against the distal end of the stent, so as to prevent the stent from being driven during the recovery process, causing the stent to Displacement, or deformation of the distal port of the stent, or even shrinkage, causing vascular occlusion.
本公开的第二实施例提供一种血流导向装置,其包括导入鞘管、支架以及上述任一项实施方式中的所述输送导丝,所述输送导丝设置在所述导入鞘管中,所述支架能够设置在所述输送导丝中,尤其设置在所述输送导丝的所述芯轴11内。The second embodiment of the present disclosure provides a blood flow guiding device, which includes an introduction sheath, a stent, and the delivery guide wire in any one of the above-mentioned embodiments, and the delivery guide wire is set in the introduction sheath , the stent can be arranged in the delivery guidewire, especially in the mandrel 11 of the delivery guidewire.
本公开实施例能够用于血流导向装置中,不但能够保持较好的柔顺性和血管超选的性能,还能够针对不同的使用场景将所述支架输送到患者血管中的指定位置。The embodiments of the present disclosure can be used in the blood flow guiding device, not only can maintain good flexibility and blood vessel super-selection performance, but also can deliver the stent to a designated position in the patient's blood vessel according to different usage scenarios.
以上描述仅为本公开的较佳实施例以及对所运用技术原理的说明。本领域技术人员应当理解,本公开中所涉及的公开范围,并不限于上述技术特征的特定组合而成的技术方案,同时也应涵盖在不脱离上述公开构思的情况下,由上述技术特征或其等同特征进行任意组合而形成的其它技术方案。例如上述特征与本公开中公开的(但不限于)具有类似功能的技术特征进行互相替换而形成的技术方案。The above description is only a preferred embodiment of the present disclosure and an illustration of the applied technical principles. Those skilled in the art should understand that the disclosure scope involved in this disclosure is not limited to the technical solution formed by the specific combination of the above-mentioned technical features, but also covers the technical solutions formed by the above-mentioned technical features or Other technical solutions formed by any combination of equivalent features. For example, a technical solution formed by replacing the above-mentioned features with (but not limited to) technical features with similar functions disclosed in this disclosure.
此外,虽然采用特定次序描绘了各操作,但是这不应当理解为要求这些操作以所示出的特定次序或以顺序次序执行来执行。在一定环境下,多任务和并行处理可能是有利的。同样地,虽然在上面论述中包含了若干具体实现细节,但是这些不应当被解释为对本公开的范围的限制。在单独的实施例的上下文中描述的某些特征还可以组合地实现在单个实施例中。相反地,在单个实施例的上下文中描述的各种特征也可以单独地或以任何合适的子组合的方式实现在多个实施例中。In addition, while operations are depicted in a particular order, this should not be understood as requiring that the operations be performed in the particular order shown or performed in sequential order. Under certain circumstances, multitasking and parallel processing may be advantageous. Likewise, while the above discussion contains several specific implementation details, these should not be construed as limitations on the scope of the disclosure. Certain features that are described in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination.
尽管已经采用特定于结构特征和/或方法逻辑动作的语言描述了本主题,但是应当理解所附权利要求书中所限定的主题未必局限于上面描述的特定特征或动作。相反,上面所描述的特定特征和动作仅仅是实现权利要求书的示例形式。Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are merely example forms of implementing the claims.
以上对本公开多个实施例进行了详细说明,但本公开不限于这些具体的实施例,本领域技术人员在本公开构思的基础上,能够做出多种变型和修改实施例,这些变型和修改都应落入本公开所要求保护的范围。Multiple embodiments of the present disclosure have been described in detail above, but the present disclosure is not limited to these specific embodiments. Those skilled in the art can make various variations and modifications on the basis of the concept of the disclosure. These variations and modifications All should fall within the scope of protection claimed by the present disclosure.

Claims (21)

  1. 一种输送导丝,其特征在于,包括连续形成的压握段和显影段,所述压握段包括可弯曲的芯轴,在所述芯轴的靠近其近端部的位置设置至少一个柔性的摩擦垫,在所述芯轴的靠近其远端部的位置设置至少一个膨胀体,所述膨胀体具有沿所述芯轴的径向方向上的向外自动膨胀的能力,所述膨胀体的靠近所述摩擦垫的端部与所述芯轴之间在轴向上固定连接,所述膨胀体的远离所述摩擦垫的端部与所述芯轴之间在轴向上滑动连接,在所述显影段的近端设置至少一个保护体。A delivery guide wire, characterized in that it includes a continuously formed crimping section and a developing section, the crimping section includes a bendable mandrel, and at least one flexible The friction pad is provided with at least one expansion body near the distal end of the mandrel, the expansion body has the ability to self-expand outward along the radial direction of the mandrel, and the expansion body The end of the expansion body close to the friction pad is fixedly connected to the mandrel in the axial direction, and the end of the expansion body away from the friction pad is slidably connected to the mandrel in the axial direction, At least one protective body is arranged near the developing section.
  2. 根据权利要求1所述的输送导丝,其特征在于,所述芯轴为具有固定延伸长度的管状结构或者为可伸缩的管状结构。The delivery guide wire according to claim 1, wherein the mandrel is a tubular structure with a fixed extension length or a telescopic tubular structure.
  3. 根据权利要求1所述的输送导丝,其特征在于,所述摩擦垫设置在所述芯轴上,其与所述芯轴在轴向上的相对位置固定,在所述芯轴11的径向上绕所述芯轴转动或者相对所述芯轴固定。The delivery guide wire according to claim 1, wherein the friction pad is arranged on the mandrel, and its relative position with the mandrel in the axial direction is fixed, and the diameter of the mandrel 11 is Rotate upwardly about the mandrel or be fixed relative to the mandrel.
  4. 根据权利要求3所述的输送导丝,其特征在于,所述摩擦垫以环绕包裹的方式固定在所述芯轴上或者在所述芯轴上环绕设置多圈的绕簧,所述摩擦垫固定在所述绕簧上。The delivery guide wire according to claim 3, characterized in that, the friction pad is fixed on the mandrel in a wrapping manner or a multi-turn coil spring is arranged around the mandrel, and the friction pad fixed on the coil spring.
  5. 根据权利要求4所述的输送导丝,其特征在于,所述绕簧采用铂-铱合金制成。The delivery guide wire according to claim 4, wherein the coil spring is made of platinum-iridium alloy.
  6. 根据权利要求1所述的输送导丝,其特征在于,当所述摩擦垫的数量为多个时,多个所述摩擦垫依次在所述芯轴上布置。The delivery guide wire according to claim 1, wherein when there are multiple friction pads, multiple friction pads are arranged on the mandrel in sequence.
  7. 根据权利要求1所述的输送导丝,其特征在于,所述摩擦垫采用圆柱体、纺锤体、球体中的至少一种结构。The delivery guide wire according to claim 1, wherein the friction pad adopts at least one structure among cylinder, spindle and sphere.
  8. 根据权利要求1所述的输送导丝,其特征在于,所述摩擦垫采用聚合物材料制成。The delivery guide wire according to claim 1, wherein the friction pad is made of polymer material.
  9. 根据权利要求8所述的输送导丝,其特征在于,所述聚合物材料为TPU材料或者硅胶材料。The delivery guide wire according to claim 8, characterized in that, the polymer material is TPU material or silica gel material.
  10. 根据权利要求1所述的输送导丝,其特征在于,所述膨胀体的数量是多个,多个所述膨胀体在所述芯轴上靠近其远端部的位置依次布置。The delivery guide wire according to claim 1, characterized in that there are multiple expansion bodies, and the plurality of expansion bodies are arranged in sequence on the mandrel near its distal end.
  11. 根据权利要求1所述的输送导丝,其特征在于,所述膨胀体采用金属笼的结构。The delivery guide wire according to claim 1, wherein the expansion body adopts a metal cage structure.
  12. 根据权利要求1所述的输送导丝,其特征在于,所述膨胀体采用具有中空结构的聚合物弹性体,所述聚合物弹性体设置为单层多孔结构。The delivery guide wire according to claim 1, characterized in that, the expansion body is a polymer elastomer with a hollow structure, and the polymer elastomer is configured as a single-layer porous structure.
  13. 根据权利要求11所述的输送导丝,其特征在于,当所述膨胀体采用金属笼的结构时,其具有相互连接的枝干,在所述枝干上设置显影材料。The delivery guide wire according to claim 11, wherein when the expansion body adopts a metal cage structure, it has interconnected branches, and a developing material is arranged on the branches.
  14. 根据权利要求13所述的输送导丝,其特征在于,所述显影材料是铂铱合金、铂钨合金、黄金、钽合金中的至少一种。The delivery guide wire according to claim 13, wherein the imaging material is at least one of platinum-iridium alloy, platinum-tungsten alloy, gold, and tantalum alloy.
  15. 根据权利要求13所述的输送导丝,其特征在于,所述显影材料的形状是片状、丝状、环状中的至少一种。The delivery guide wire according to claim 13, wherein the shape of the developing material is at least one of sheet shape, wire shape and ring shape.
  16. 根据权利要求15所述的输送导丝,其特征在于,所述显影材料在所述枝干上的安装方式根据所述显影材料的形状采用镶嵌、绕丝、套环中的至少一种。The delivery guide wire according to claim 15, characterized in that, according to the shape of the developing material, the installation method of the developing material on the branch adopts at least one of inlay, wire wrapping and looping.
  17. 根据权利要求1所述的输送导丝,其特征在于,所述显影段的远端设置为弧形结构,所述弧形结构是U形结构或者J形结构。The delivery guide wire according to claim 1, wherein the distal end of the developing section is arranged in an arc-shaped structure, and the arc-shaped structure is a U-shaped structure or a J-shaped structure.
  18. 根据权利要求1所述的输送导丝,其特征在于,所述保护体的形状设置为球体、椭球体或锥体中的至少一种。The delivery guide wire according to claim 1, wherein the shape of the protective body is at least one of a sphere, an ellipsoid or a cone.
  19. 根据权利要求18所述的输送导丝,其特征在于,所述保护体的材料采用锡、UV胶、高分子聚合物、可显影合金材料中的一种。The delivery guide wire according to claim 18, characterized in that, the material of the protective body is one of tin, UV glue, high molecular polymer, and developable alloy material.
  20. 根据权利要求1所述的输送导丝,其特征在于,在所述显影段的近端设置第一保护体和第二保护体,所述第一保护体远离所述压握段设置,所述第二保护体靠近所述压握段设置。The delivery guide wire according to claim 1, wherein a first protective body and a second protective body are arranged at the proximal end of the developing section, the first protective body is arranged away from the crimping section, and the The second protection body is arranged close to the crimping section.
  21. 一种血流导向装置,其特征在于,包括导入鞘管、支架以及上述任一项权利要求中的所述输送导丝,所述输送导丝设置在所述导入鞘管中,所述支架能够设置在所述输送导丝中。A blood flow guiding device, characterized in that it comprises an introduction sheath, a stent, and the delivery guidewire according to any one of the above claims, the delivery guidewire is set in the introduction sheath, and the stent can disposed within the delivery guidewire.
PCT/CN2022/113732 2021-08-23 2022-08-19 Delivery guide wire and blood flow guiding apparatus WO2022253364A1 (en)

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CN113208791A (en) * 2021-04-28 2021-08-06 聚辉医疗科技(深圳)有限公司 Conveyor and blood flow guiding bracket system
CN114451946A (en) * 2021-08-23 2022-05-10 上海心玮医疗科技股份有限公司 Carry seal wire and blood flow guider

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116269968A (en) * 2023-05-24 2023-06-23 北京久事神康医疗科技有限公司 Vascular stent conveying system
CN116269968B (en) * 2023-05-24 2023-09-26 北京久事神康医疗科技有限公司 Vascular stent conveying system

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