WO2022041593A1 - 可视化追踪定位的血流导向装置输送系统及追踪定位方法 - Google Patents

可视化追踪定位的血流导向装置输送系统及追踪定位方法 Download PDF

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Publication number
WO2022041593A1
WO2022041593A1 PCT/CN2020/137899 CN2020137899W WO2022041593A1 WO 2022041593 A1 WO2022041593 A1 WO 2022041593A1 CN 2020137899 W CN2020137899 W CN 2020137899W WO 2022041593 A1 WO2022041593 A1 WO 2022041593A1
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Prior art keywords
marker
blood flow
distal
release
distal end
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PCT/CN2020/137899
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English (en)
French (fr)
Inventor
许永松
穆磊
唐航
秦川
吴健
王金磊
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北京泰杰伟业科技有限公司
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Priority to US18/042,672 priority Critical patent/US20230329729A1/en
Publication of WO2022041593A1 publication Critical patent/WO2022041593A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/823—Stents, different from stent-grafts, adapted to cover an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09166—Guide wires having radio-opaque features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers

Definitions

  • the invention relates to the technical field of special equipment, in particular to a blood flow guiding device delivery system and a tracking and positioning method for visual tracking and positioning.
  • the blood flow diverter is usually a braided stent with high metal surface coverage. At present, there are more mature blood flow guidance products, and the product structure of different companies is slightly different.
  • the present application proposes a new technical solution for this difficulty.
  • the purpose of the present invention is to provide a blood flow guiding device delivery system and a tracking and positioning method for visual tracking and positioning, which can visually carry out the precise control of the release and recovery or secondary release of the blood flow guiding device in the whole process.
  • an embodiment of the present invention provides a blood flow guide device delivery system for visual tracking and positioning.
  • the blood flow guide device delivery system includes: a blood flow guide device, a push guide wire, a support spring, a distal end Springs, friction pads, distal markers, proximal markers and full release markers;
  • the distal end spring, distal end marker, blood flow guide device, proximal end marker, friction pad, complete release marker and support spring are sequentially arranged on the pushing guide wire from distal end to proximal end; wherein, the distal end End springs, distal markers, blood flow diverters, proximal markers and full release markers are made of materials that can be visualized under contrast;
  • the distal spring is arranged at the distal end of the push guide wire
  • the distal marker is arranged at the proximal end of the distal spring, and there is a gap of 1mm-5mm between the proximal end of the distal spring and the distal marker, so as to indicate that the blood flow guiding device is in the microscopic state. Positioning during intraluminal delivery of the catheter; wherein, when the distal end marker is aligned with the distal end marker of the microcatheter lumen, it indicates the initial state of release of the blood flow guide device;
  • the blood flow diverter is preloaded between the distal marker and the full release marker
  • the friction pad is arranged on the distal side of the complete release mark, and has a gap of 1mm-5mm with the complete release mark; the proximal end mark is arranged on a distal end of the friction pad. side; the friction pad is used to stabilize the delivery of the push guide wire and the blood flow guide device in the microcatheter lumen;
  • the complete release marker is disposed at the distal end of the support spring, and when the complete release marker is aligned with the distal end marker of the microcatheter lumen, indicates the completion state of the blood flow guide device release.
  • the proximal marker when aligned with the distal marker of the microcatheter lumen, it indicates that the release of the blood flow guide device is about to be completed.
  • the friction pad is made of UV-curable glue.
  • the push guide wire is tapered and has a polytetrafluoroethylene PTFE coating guide wire at the proximal end, and the total length is 190cm-230cm, wherein the push guide wire has a coating length at the proximal end of 150cm -190cm;
  • the length of the friction pad is 5mm-20mm, the outer diameter is 0.40mm-0.60mm, the precision is 0.01mm, the hardness is 30D-40D, and the distance between the friction pad and the end of the push guide wire is 5cm-25cm .
  • the minimum diameter of the distal end of the pushing guide wire is between 0.08mm-0.20m, and the maximum diameter of the proximal end is between 0.36mm-0.50mm.
  • the two ends of the support spring are fixed together with the push guide wire by means of ultraviolet UV curing glue or soldering;
  • the material of the distal spring is platinum-tungsten alloy or platinum-iridium alloy, the primary wire diameter is 0.04mm-0.07mm, and the length is 0.5cm-3cm;
  • the distal spring and the pushing guide wire are assembled together by means of UV curing glue or soldering, and the distal end of the distal spring has a distal ball cap.
  • the material of the distal marker, the proximal marker and the fully released marker is platinum-tungsten alloy or platinum-iridium alloy
  • the distance between the distal marker and the fully released marker is 2cm-8cm
  • the distal marker , the proximal marker and the complete release marker have diameters between 0.4mm-0.7mm, and widths between 0.5mm-2mm, respectively.
  • an embodiment of the present invention provides a visual tracking and positioning method for a blood flow guiding device in the blood flow guiding device delivery system for visual tracking and positioning described in the first aspect above.
  • the visual tracking and positioning method includes:
  • the microcatheter is withdrawn, so that the blood flow guiding device is gradually released from the distal end to the proximal end, and the relative positions of the proximal end marker and the complete release marker and the distal end marker of the microcatheter lumen are tracked in real time under angiography; wherein, the release During the process, the blood flow guiding device gradually changes from a compressed state to an open state;
  • the blood flow director release is complete when the full release marker is aligned with the distal marker of the microcatheter lumen.
  • the method further includes: withdrawing the push guide wire and the distal spring, distal end marker, proximal end marker, friction pad, Fully release the marker and support spring.
  • the method further comprises:
  • the blood flow guiding device delivery system for visual tracking and positioning adopts a distal marker, a proximal marker and a complete release marker to indicate the positioning of the blood flow guiding device during the delivery process in the microcatheter cavity.
  • Mark the release start state mark the completion status by completely releasing the mark, and indicate the critical point of the release to be completed by the proximal mark and indicate whether the blood flow guide device can be recovered, so that the whole process can be visualized, tracked and positioned, and greatly improved. Improved handling accuracy.
  • the friction pad made of ultraviolet curing glue has high precision, strong adhesion with the guide wire, uniform and controllable hardness, and improves the reliability of the release and recovery process of the blood flow guide device.
  • FIG. 1 is a schematic structural diagram of a blood flow guiding device for visual tracking and positioning provided by an embodiment of the present invention
  • FIG. 2 is a flowchart of a visual tracking and positioning method provided by an embodiment of the present invention
  • FIG. 3 is one of schematic diagrams of a visual tracking and positioning process provided by an embodiment of the present invention.
  • FIG. 4 is a second schematic diagram of a visual tracking and positioning process provided by an embodiment of the present invention.
  • FIG. 5 is a third schematic diagram of a visual tracking and positioning process provided by an embodiment of the present invention.
  • FIG. 6 is a fourth schematic diagram of a visual tracking and positioning process provided by an embodiment of the present invention.
  • An embodiment of the present invention provides a blood flow guide device for visual tracking and positioning, the structure of which is shown in FIG. 1 , including: a blood flow guide device 8 , a push guide wire 1 , a support spring 2 , a distal spring 3 , and a friction pad 4. Distal marker 5, proximal marker 7 and complete release marker 6;
  • a distal spring 3, a distal marker 5, a blood flow guide device 8, a proximal marker 7, a friction pad 4, a complete release marker 6 and a support spring 2 are sequentially arranged on the push guide wire 1 from the distal end to the proximal end; wherein , the distal spring 3, the distal marker 5, the blood flow guide device 8, the proximal marker 7 and the complete release marker 6 are made of materials that can be visualized under angiography;
  • the distal spring 3 is arranged at the distal end of the push guide wire 1;
  • the distal end marker 5 is arranged at the proximal end of the distal end spring 3, and there is a gap of 1mm-5mm between the proximal end of the distal end spring 3 and the distal end marker 5 to clearly indicate that the blood flow guide device 8 is in the microcatheter lumen Positioning during delivery; wherein, when the distal marker 5 is aligned with the distal marker 5 of the microcatheter lumen, it indicates the initial state of the release of the blood flow guide device 8;
  • the blood flow guide device 8 is pre-installed between the distal marker 5 and the complete release marker 6;
  • the friction pad 4 is arranged on the distal side of the complete release mark 6, and has a gap of 1mm-5mm with the complete release mark 6; intraluminal delivery of catheters;
  • the proximal end marker 7 is arranged on the distal side of the friction pad 4; when the proximal end marker 7 is aligned with the distal end marker 5 of the microcatheter lumen, it indicates that the release of the blood flow guiding device 8 is about to be completed, so that the release can be almost finished At the same time, the proximal marker 7 is also used to indicate the critical point of recovery during the release of the blood flow guide device 8. Before the proximal marker 7 is aligned with the distal marker 5 of the microcatheter lumen, it can be performed The recovery of the blood flow guide device 8, so that in the case of inaccurate positioning at one time, the position of the microcatheter can be readjusted and then released.
  • the proximal marker 7 When the proximal marker 7 is aligned with the distal marker 5 of the microcatheter lumen, it can no longer be retrieved.
  • the visual position observation can clearly indicate to the operator whether the blood flow guide device 8 is in a recoverable state, so as to prevent the blood flow guide
  • the operator When the device 8 has reached the non-recoverable position, the operator performs the recovery operation of the blood flow guide device 8 again, which may damage the blood flow guide device or bring about other harms.
  • a complete release mark 6 is provided at the distal end of the support spring 2, and when the complete release mark 6 is aligned with the distal mark 5 of the microcatheter lumen, indicates the completion state of the release of the blood flow guide 8.
  • the push guide wire 1 is tapered and has a polytetrafluoroethylene (PTFE) coated guide wire at the proximal end, and the total length is 190cm-230cm, wherein the push guide wire 1 has a coated length at the proximal end of 150cm-190cm;
  • PTFE polytetrafluoroethylene
  • the friction pad 4 is made of a UV-curable adhesive with high fluidity and suitable hardness; the length is 5mm-20mm, the outer diameter is 0.40mm-0.60mm, the precision is 0.01mm, the hardness is 30D-40D, and the friction pad
  • the distance between the sheet 4 and the distal end on the proximal side of the pushing guide wire 1 is 5 cm-25 cm.
  • the specific preparation process of the friction gasket 4 can be as follows: with a tearable polyolefin heat shrinkable tube or FEP heat shrinkable tube, one or two notches are pre-processed at one end or both ends of the heat shrinkable tube to facilitate subsequent peeling.
  • Both ends of the support spring 2 are fixed to the push guide wire 1 by means of UV curing glue or soldering; in this example, the support spring 2 is a densely wound 304 stainless steel spring, the primary wire diameter is 0.04mm-0.08mm, The length is 5cm-20cm.
  • the material of the distal spring 3 is platinum-tungsten alloy or platinum-iridium alloy, the primary wire diameter is 0.04mm-0.07mm, and the length is 0.5cm-3cm; the distal spring 3 and the push wire 1 are made of UV curing glue or soldering Assembled together, the distal end of the distal spring 3 has a distal spherical cap, which is made of polymer material or metal material. Further, in order to improve the softness of the distal spring 3, heat treatment is performed at 580°C-650°C before assembling with the push guide wire 1.
  • the specific shape can be straight as shown in Figure 1, or can be J-shaped or S-shaped. sex.
  • Distal marker 5, proximal marker 7 and complete release marker 6 are made of platinum-tungsten alloy or platinum-iridium alloy, the distance between distal marker 5 and complete release marker 6 is 2cm-8cm, distal marker 5, proximal marker The diameter of the marker 7 and the complete release marker 6 are respectively between 0.4mm-0.7mm, and the width is between 0.5mm-2mm, respectively.
  • the whole process of visual tracking and positioning of the blood flow guide device 8 can be realized during the delivery process of the blood flow guide device 8 .
  • the operation convenience of releasing the blood flow guide device 8 and the accuracy and precision of the releasing position can be effectively improved.
  • FIG. 2 is a flowchart of a visual tracking and positioning method provided by an embodiment of the present invention.
  • Figures 3 to 6 are schematic diagrams of several states during the implementation of the method, and the method of the present invention is described with reference to Figures 2 to 6 .
  • the main steps include:
  • Step 210 after pushing the blood flow guiding device into the microcatheter lumen, under angiography, push the guide wire to align the distal mark of the blood flow guiding device delivery system with the distal end mark of the microcatheter lumen, bring the blood flow diverter to the starting position for release;
  • the microcatheter is firstly sent to an appropriate position, as shown in FIG. 3 .
  • This position is optimal 3-5 cm beyond the center of the release position of the blood flow diverter.
  • the end of the microcatheter lumen has a distal marker of the microcatheter lumen visible under contrast.
  • Figure 4 shows the state when the distal cap of the delivery system of the blood flow diverter is aligned with the distal marker of the microcatheter lumen.
  • the friction pads are not shown in this figure.
  • Step 220 withdraw the microcatheter, so that the blood flow guide device is gradually released from the distal end to the proximal end, and track the relative positions of the proximal end marker and the fully released marker and the distal end marker of the microcatheter lumen in real time under angiography;
  • the blood flow guide device gradually changes from a compressed state to an open state; as shown in FIG. 5 .
  • Step 230 when the fully released marker is aligned with the distal marker of the microcatheter lumen, the blood flow guide device is released.
  • the microcatheter can be stopped before the proximal end mark is aligned with the distal end mark of the microcatheter lumen, and the microcatheter is withdrawn. Push the microcatheter, so that the released blood flow guide device is gradually compressed from the proximal end to the distal end, and then retracted into the microcatheter lumen; When it is aligned again, it means that the delivery system of the blood flow guide device is fully recovered into the microcatheter. At this time, the position of the microcatheter can be adjusted, and then the blood flow guide device can be re-released, or the microcatheter and the blood flow guide device in the microcatheter can be withdrawn for delivery. system.
  • the blood flow guiding device delivery system for visual tracking and positioning adopts a distal marker, a proximal marker and a complete release marker to indicate the positioning of the blood flow guiding device during the delivery process in the microcatheter cavity.
  • Mark the release start state mark the completion status by completely releasing the mark, and indicate the critical point of the release to be completed by the proximal mark and indicate whether the blood flow guide device can be recovered, so that the whole process can be visualized, tracked and positioned, and greatly improved. Improved handling accuracy.
  • the friction pad made of ultraviolet curing glue has high precision, strong adhesion with the guide wire, uniform and controllable hardness, and improves the reliability of the release and recovery process of the blood flow guide device.
  • a software module can be placed in random access memory (RAM), internal memory, read only memory (ROM), electrically programmable ROM, electrically erasable programmable ROM, registers, hard disk, removable disk, CD-ROM, or any other in the technical field. in any other known form of storage medium.
  • RAM random access memory
  • ROM read only memory
  • electrically programmable ROM electrically erasable programmable ROM
  • registers hard disk, removable disk, CD-ROM, or any other in the technical field. in any other known form of storage medium.

Abstract

一种可视化追踪定位的血流导向装置输送系统及追踪定位方法，血流导向装置输送系统包括：血流导向装置(8)、推送导丝(1)、支撑弹簧(2)、远端弹簧(3)、摩擦垫片(4)、远端标记(5)、近端标记(7)和完全释放标记(6)；远端弹簧(3)设置在推送导丝(1)的远端；远端标记(5)设置在远端弹簧(3)的近端；其中，远端标记(5)与微导管腔的远端标记对准时指示血流导向装置(8)释放的起始状态；血流导向装置(8)预装在远端标记(5)与完全释放标记(6)之间；摩擦垫片(4)设置在完全释放标记(6)的远端一侧；近端标记(7)设置在摩擦垫片(4)的远端一侧；摩擦垫片(4)用于稳固推送导丝(1)推送血流导向装置(8)在微导管腔内的输送；完全释放标记(6)设置在支撑弹簧(2)的远端，完全释放标记(6)与微导管腔的远端标记对准时指示血流导向装置(8)释放的完成状态。

Description

可视化追踪定位的血流导向装置输送系统及追踪定位方法
本申请要求于2020年08月24日提交中国专利局、申请号为202010857374.0、发明名称为“可视化追踪定位的血流导向装置输送系统及追踪定位方法”的中国专利申请的优先权。
本发明涉及专用器械技术领域，尤其涉及可视化追踪定位的血流导向装置输送系统及追踪定位方法。
背景技术
血流导向装置通常是一种高金属表面覆盖率的编织支架。目前较成熟的血流导向产品较多，不同公司的产品结构略有不同。
如何可视化追踪定位的血流导向装置的输送过程，一直是一个技术难点，尤其是可回收的血流导向装置的释放及回收控制。
本申请正是针对这一难点，提出了新的技术方案。
发明内容
本发明的目的是提供一种可视化追踪定位的血流导向装置输送系统及追踪定位方法，能够全过程可视化的进行对血流导向装置的释放及回收或二次释放的精确控制。
为此，第一方面，本发明实施例提供了一种可视化追踪定位的血流导向装置输送系统，所述血流导向装置输送系统包括：血流导向装置、推送导丝、支撑弹簧、远端弹簧、摩擦垫片、远端标记、近端标记和完全释放标记；
所述远端弹簧、远端标记、血流导向装置、近端标记、摩擦垫片、完全释放标记和支撑弹簧依次由远端至近端设置在所述推送导丝上；其中，所述远端弹簧、远端标记、血流导向装置、近端标记和完全释放标记为在造影下可显影的材料制成；
所述远端弹簧设置在所述推送导丝的远端；
所述远端标记设置在所述远端弹簧的近端，所述远端弹簧的近端与所述远端标记之间具有1mm-5mm的间隙，用以指示所述血流导向装置在微导管腔内输送过程中的定位；其中，所述远端标记与所述微导管腔的远端标记对准时指示所述血流导向装置释放的起始状态；
所述血流导向装置预装在所述远端标记与所述完全释放标记之间；
所述摩擦垫片设置在所述完全释放标记的远端一侧，且与所述完全释放标记之间具有1mm-5mm的间隙；所述近端标记设置在所述摩擦垫片的远端一侧；所述摩擦垫片用于稳固所述推送导丝推送所述血流导向装置在所述微导管腔内的输送；
所述完全释放标记设置在所述支撑弹簧的远端，所述完全释放标记与所述微导管腔的远端标记对准时指示所述血流导向装置释放的完成状态。
优选的，所述近端标记与所述微导管腔的远端标记对准时指示所述血流导向装置释放即将完成的状态。
优选的，所述摩擦垫片由紫外光固化胶制成。
优选的，所述推送导丝为锥形且近端带有聚四氟乙烯PTFE涂层导丝，总长为190cm-230cm,其中，所述推送导丝在近端带有涂层的长度为150cm-190cm；
所述摩擦垫片的长度为5mm-20mm，外径尺寸0.40mm-0.60mm，精度0.01mm，硬度为30D-40D，所述摩擦垫片距离所述推送导丝的末端的距离为5cm-25cm。
进一步优选的，所述推送导丝的远端最小直径在0.08mm-0.20m之间， 近端最大直径在0.36mm-0.50mm之间。
优选的，所述支撑弹簧的两端采用紫外线UV固化胶或锡焊的方式与推送导丝固定到一起；
所述远端弹簧的材质为铂钨合金或铂铱合金，初级丝径为0.04mm-0.07mm，长度为0.5cm-3cm；
所述远端弹簧与所述推送导丝采用UV固化胶或锡焊的方式组装到一起，所述远端弹簧的末端具有的远端球帽。
优选的，所述远端标记、近端标记和完全释放标记的材质为铂钨合金或铂铱合金，所述远端标记和完全释放标记之间的间距为2cm-8cm,所述远端标记、近端标记和完全释放标记的直径分别在0.4mm-0.7mm之间，宽度分别在0.5mm-2mm之间。
第二方面，本发明实施例提供了一种上述第一方面所述的可视化追踪定位的血流导向装置输送系统中血流导向装置的可视化追踪定位方法，所述可视化追踪定位方法包括：
在将血流导向装置推送至微导管腔内后，在造影下，推动推送导丝，使血流导向装置输送系统的远端标记与微导管腔的远端标记对准，使所述血流导向装置到达释放的起始位置；
回撤微导管，使得血流导向装置由远端至近端逐步释放，并在造影下实时追踪近端标记和完全释放标记与微导管腔的远端标记的相对位置；其中，所述释放过程中，所述血流导向装置由压缩状态逐步变为打开状态；
当完全释放标记与微导管腔的远端标记对准时，所述血流导向装置释放完成。
优选的，在所述血流导向装置释放完成后，所述方法还包括：撤回推送导丝及设置在所述推送导丝上的远端弹簧、远端标记、近端标记、摩擦垫片、完全释放标记和支撑弹簧。
优选的，在回撤微导管的过程中，所述近端标记与所述微导管腔的远端 标记对准之前，所述方法还包括：
停止回撤微导管，并推送所述微导管，使得已经释放的血流导向装置由近端至远端逐步压缩，重新收回至微导管腔内；
当所述血流导向装置输送系统的远端标记与微导管腔的远端标记再次对准时，调整所述微导管位置并重新释放所述血流导向装置，或者撤出所述微导管连同所述微导管内的血流导向装置输送系统。
本发明实施例提供的可视化追踪定位的血流导向装置输送系统，采用远端标记、近端标记和完全释放标记指示血流导向装置在微导管腔内输送过程中的定位,通过远端标记标记释放起始状态,通过完全释放标记标记完成状态,通过近端标记提示释放即将完成的状态并且指示血流导向装置是否可进行回收操作的临界点,使得全过程可视,可追踪定位,大大提高了操控准确性。此外采用紫外光固化胶制成摩擦垫片精度高，与导丝之间粘接力强，硬度均匀可控，提高血流导向装置释放及回收过程的可靠性。
附图说明
图1为本发明实施例提供的可视化追踪定位的血流导向装置的结构示意图；
图2为本发明实施例提供的可视化追踪定位方法流程图；
图3为本发明实施例提供的可视化追踪定位过程示意图之一；
图4为本发明实施例提供的可视化追踪定位过程示意图之二；
图5为本发明实施例提供的可视化追踪定位过程示意图之三；
图6为本发明实施例提供的可视化追踪定位过程示意图之四。
具体实施方式
下面通过附图和实施例，对本发明的技术方案做进一步的详细描述。
本发明实施例提供了一种可视化追踪定位的血流导向装置，其结构如图 1所示，包括：血流导向装置8、推送导丝1、支撑弹簧2、远端弹簧3、摩擦垫片4、远端标记5、近端标记7和完全释放标记6；
以图示中远端弹簧3一侧为远端，推送导丝1的操作端(即图中右侧方向)为近端，进行各部件位置关系的描述。
远端弹簧3、远端标记5、血流导向装置8、近端标记7、摩擦垫片4、完全释放标记6和支撑弹簧2依次由远端至近端设置在推送导丝1上；其中，远端弹簧3、远端标记5、血流导向装置8、近端标记7和完全释放标记6为在造影下可显影的材料制成；
远端弹簧3设置在推送导丝1的远端；
远端标记5设置在远端弹簧3的近端，远端弹簧3的近端与远端标记5之间具有1mm-5mm的间隙，用以清晰指示血流导向装置8在微导管腔内输送过程中的定位；其中，远端标记5与微导管腔的远端标记5对准时指示血流导向装置8释放的起始状态；
血流导向装置8预装在远端标记5与完全释放标记6之间；
摩擦垫片4设置在完全释放标记6的远端一侧，且与完全释放标记6之间具有1mm-5mm的间隙；摩擦垫片4用于稳固推送导丝1推送血流导向装置8在微导管腔内的输送；
近端标记7设置在摩擦垫片4的远端一侧；近端标记7与微导管腔的远端标记5对准时指示血流导向装置8释放即将完成的状态，从而能够在释放快要结束时精确提示；同时，近端标记7也用于指示血流导向装置8释放过程中可回收的临界点,在近端标记7与微导管腔的远端标记5对准之前，均可进行血流导向装置8的回收，从而实现在一次定位不准确的情况下，重新调整微导管位置后再进行释放。当近端标记7与微导管腔的远端标记5对准之后不可再回收，通过可视化的位置观测能够明确指示操作人员血流导向装置8是否处于可回收的状态，以防止在血流导向装置8已经到达不可回收位置时操作人员再对血流导向装置8进行回收操作造成血流 导线装置损坏或带来其他危害。
完全释放标记6设置在支撑弹簧2的远端，完全释放标记6与微导管腔的远端标记5对准时指示血流导向装置8释放的完成状态。
在本实施例的具体实现中：
推送导丝1为锥形且近端带有聚四氟乙烯(PTFE)涂层导丝，总长为190cm-230cm,其中，推送导丝1在近端带有涂层的长度为150cm-190cm；
摩擦垫片4采用一种高流动性，软硬度合适的紫外光固化胶制成；长度为5mm-20mm，外径尺寸0.40mm-0.60mm，精度0.01mm，硬度为30D-40D，摩擦垫片4距离推送导丝1的近端一侧的末端的距离为5cm-25cm。
摩擦垫片4的具体制备过程可以如下：借助一种可撕的聚烯烃热缩管或FEP热缩管，预先在热缩管的一端或两端加工一个或两个缺口，方便后续的剥离。采用高精度的不锈钢芯轴或PTFE芯轴，先将热缩管在芯轴上进行热缩覆盖，热缩完后，移除芯轴，再将具有精确内径(等于芯轴的直径)的热缩管套于本发明专利的推送导丝1远端部分，注入紫外光固化胶使其充分填满热缩管的内部，并保持推送导丝1远端位于热缩管的中心位置，照射紫外光，5S-30S时间内可实现胶水的完全固化(5-30S)，胶水固化后，沿预设的端部缺口，将热缩管剥离，得到一体成型的摩擦垫片4，所得摩擦垫片4具有较好的粘接力，能够与推送导丝1很好的固定，且摩擦垫片4的硬度均匀可控。
支撑弹簧2的两端采用紫外线UV固化胶或锡焊的方式与推送导丝1固定到一起；本例中，支撑弹簧2为致密缠绕的304不锈钢弹簧，初级丝径为0.04mm-0.08mm，长度为5cm-20cm。
远端弹簧3的材质为铂钨合金或铂铱合金，初级丝径为0.04mm-0.07mm，长度为0.5cm-3cm；远端弹簧3与推送导丝1采用UV固化胶或锡焊的方式组装到一起，远端弹簧3的末端具有的远端球帽，由高分子材料或金属材料制成。进一步的，为提高远端弹簧3的柔软度，在与推送导丝1组装之 前先在580℃-650℃下进行热处理定型，具体形状可以如图1呈直形，也可以呈J形或S性。
远端标记5、近端标记7和完全释放标记6的材质为铂钨合金或铂铱合金，远端标记5和完全释放标记6之间的间距为2cm-8cm,远端标记5、近端标记7和完全释放标记6的直径分别在0.4mm-0.7mm之间，宽度分别在0.5mm-2mm之间。
采用上述可视化追踪定位的血流导向装置8，能够在血流导向装置8输送过程中实现血流导向装置8的全程可视化追踪定位。能够有效提高血流导向装置8释放的操作便捷度和释放位置的准确度、精确度。
图2为本发明实施例提供的可视化追踪定位方法流程图。图3-图6为该方法实施过程中的几个状态示意图，结合图2-图6说明本发明的方法。
主要步骤包括：
步骤210，在将血流导向装置推送至微导管腔内后，在造影下，推动推送导丝，使血流导向装置输送系统的远端标记与微导管腔的远端标记对准，使血流导向装置到达释放的起始位置；
具体的，在血流导向装置推送到微导管腔内前，首先先要将微导管送至适当的位置，如图3所示。这个位置以超出血流导向装置释放位置的中心位置3-5cm为最优。微导管腔的端部具有造影下可视的微导管腔的远端标记。
随后，使用血流导向装置输送系统将血流导向装置送至微导管腔内。输送血流导向装置输送系统的远端球帽与微导管腔的远端标记对准时状态如图4所示。此图中摩擦垫片未示出。
步骤220，回撤微导管，使得血流导向装置由远端至近端逐步释放，并在造影下实时追踪近端标记和完全释放标记与微导管腔的远端标记的相对位置；
具体的，在释放过程中，血流导向装置由压缩状态逐步变为打开状态； 可如图5所示。
步骤230，当完全释放标记与微导管腔的远端标记对准时，血流导向装置释放完成。
释放完成后，血流导向装置完全打开状态。释放已完成的一个状态如图6所示。
在血流导向装置释放完成后，撤回推送导丝及设置在推送导丝上的远端弹簧、远端标记、近端标记、摩擦垫片、完全释放标记和支撑弹簧，即完成血流导向装置的整个释放过程。
进一步的，在释放过程中，如果发生需要调整释放位置，或者停止释放整体撤回的情况，可以在近端标记与所述微导管腔的远端标记对准之前，停止回撤微导管，并推送微导管，使得已经释放的血流导向装置由近端至远端逐步压缩，重新收回至微导管腔内；当血流导向装置输送系统的远端标记与微导管腔的远端标记再次对准时，表明血流导项装置输送系统全部回收到微导管内，此时可调整微导管位置，然后重新释放血流导向装置，或者撤出微导管连同微导管内的血流导向装置输送系统。
本发明实施例提供的可视化追踪定位的血流导向装置输送系统，采用远端标记、近端标记和完全释放标记指示血流导向装置在微导管腔内输送过程中的定位,通过远端标记标记释放起始状态,通过完全释放标记标记完成状态,通过近端标记提示释放即将完成的状态并且指示血流导向装置是否可进行回收操作的临界点,使得全过程可视,可追踪定位,大大提高了操控准确性。此外采用紫外光固化胶制成摩擦垫片精度高，与导丝之间粘接力强，硬度均匀可控，提高血流导向装置释放及回收过程的可靠性。
专业人员应该还可以进一步意识到，结合本文中所公开的实施例描述的各示例的单元及算法步骤，能够以电子硬件、计算机软件或者二者的结合来实现，为了清楚地说明硬件和软件的可互换性，在上述说明中已经按照 功能一般性地描述了各示例的组成及步骤。这些功能究竟以硬件还是软件方式来执行，取决于技术方案的特定应用和设计约束条件。专业技术人员可以对每个特定的应用来使用不同方法来实现所描述的功能，但是这种实现不应认为超出本发明的范围。
结合本文中所公开的实施例描述的方法或算法的步骤可以用硬件、处理器执行的软件模块，或者二者的结合来实施。软件模块可以置于随机存储器(RAM)、内存、只读存储器(ROM)、电可编程ROM、电可擦除可编程ROM、寄存器、硬盘、可移动磁盘、CD-ROM、或技术领域内所公知的任意其它形式的存储介质中。
以上所述的具体实施方式，对本发明的目的、技术方案和有益效果进行了进一步详细说明，所应理解的是，以上所述仅为本发明的具体实施方式而已，并不用于限定本发明的保护范围，凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (10)

  1. 一种可视化追踪定位的血流导向装置输送系统，其特征在于，所述血流导向装置输送系统包括：血流导向装置、推送导丝、支撑弹簧、远端弹簧、摩擦垫片、远端标记、近端标记和完全释放标记；
    所述远端弹簧、远端标记、血流导向装置、近端标记、摩擦垫片、完全释放标记和支撑弹簧依次由远端至近端设置在所述推送导丝上；其中，所述远端弹簧、远端标记、血流导向装置、近端标记和完全释放标记为在造影下可显影的材料制成；
    所述远端弹簧设置在所述推送导丝的远端；
    所述远端标记设置在所述远端弹簧的近端，所述远端弹簧的近端与所述远端标记之间具有1mm-5mm的间隙，用以指示所述血流导向装置在微导管腔内输送过程中的定位；其中，所述远端标记与所述微导管腔的远端标记对准时指示所述血流导向装置释放的起始状态；
    所述血流导向装置预装在所述远端标记与所述完全释放标记之间；
    所述摩擦垫片设置在所述完全释放标记的远端一侧，且与所述完全释放标记之间具有1mm-5mm的间隙；所述近端标记设置在所述摩擦垫片的远端一侧；所述摩擦垫片用于稳固所述推送导丝推送所述血流导向装置在所述微导管腔内的输送；
    所述完全释放标记设置在所述支撑弹簧的远端，所述完全释放标记与所述微导管腔的远端标记对准时指示所述血流导向装置释放的完成状态。
  2. 根据权利要求1所述的血流导向装置输送系统，其特征在于，所述近端标记与所述微导管腔的远端标记对准时指示所述血流导向装置释放即将完成的状态。
  3. 根据权利要求1所述的血流导向装置输送系统，其特征在于，所述摩擦垫片由紫外光固化胶制成。
  4. 根据权利要求1所述的血流导向装置输送系统，其特征在于，所述 推送导丝为锥形且近端带有聚四氟乙烯PTFE涂层导丝，总长为190cm-230cm,其中，所述推送导丝在近端带有涂层的长度为150cm-190cm；
    所述摩擦垫片的长度为5mm-20mm，外径尺寸0.40mm-0.60mm，精度0.01mm，硬度为30D-40D，所述摩擦垫片距离所述推送导丝的末端的距离为5cm-25cm。
  5. 根据权利要求4所述的血流导向装置输送系统，其特征在于，所述推送导丝的远端最小直径在0.08mm-0.20m之间，近端最大直径在0.36mm-0.50mm之间。
  6. 根据权利要求1所述的血流导向装置输送系统，其特征在于，所述支撑弹簧的两端采用紫外线UV固化胶或锡焊的方式与推送导丝固定到一起；
    所述远端弹簧的材质为铂钨合金或铂铱合金，初级丝径为0.04mm-0.07mm，长度为0.5cm-3cm；
    所述远端弹簧与所述推送导丝采用UV固化胶或锡焊的方式组装到一起，所述远端弹簧的末端具有的远端球帽。
  7. 根据权利要求1所述的血流导向装置输送系统，其特征在于，所述远端标记、近端标记和完全释放标记的材质为铂钨合金或铂铱合金，所述远端标记和完全释放标记之间的间距为2cm-8cm,所述远端标记、近端标记和完全释放标记的直径分别在0.4mm-0.7mm之间，宽度分别在0.5mm-2mm之间。
  8. 一种权利要求1-7任一所述的可视化追踪定位的血流导向装置输送系统中血流导向装置的可视化追踪定位方法，其特征在于，所述可视化追踪定位方法包括：
    在将血流导向装置推送至微导管腔内后，在造影下，推动推送导丝，使血流导向装置输送系统的远端标记与微导管腔的远端标记对准，使所述血流导向装置到达释放的起始位置；
    回撤微导管，使得血流导向装置由远端至近端逐步释放，并在造影下实时追踪近端标记和完全释放标记与微导管腔的远端标记的相对位置；其中，所述释放过程中，所述血流导向装置由压缩状态逐步变为打开状态；
    当完全释放标记与微导管腔的远端标记对准时，所述血流导向装置释放完成。
  9. 根据权利要求8所述的可视化追踪定位方法，其特征在于，在所述血流导向装置释放完成后，所述方法还包括：撤回推送导丝及设置在所述推送导丝上的远端弹簧、远端标记、近端标记、摩擦垫片、完全释放标记和支撑弹簧。
  10. 根据权利要求8所述的可视化追踪定位方法，其特征在于，在回撤微导管的过程中，所述近端标记与所述微导管腔的远端标记对准之前，所述方法还包括：
    停止回撤微导管，并推送所述微导管，使得已经释放的血流导向装置由近端至远端逐步压缩，重新收回至微导管腔内；
    当所述血流导向装置输送系统的远端标记与微导管腔的远端标记再次对准时，调整所述微导管位置并重新释放所述血流导向装置，或者撤出所述微导管连同所述微导管内的血流导向装置输送系统。
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