WO2013104324A1 - 分支型支架输送系统及用于其的导引导管 - Google Patents

分支型支架输送系统及用于其的导引导管 Download PDF

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Publication number
WO2013104324A1
WO2013104324A1 PCT/CN2013/070323 CN2013070323W WO2013104324A1 WO 2013104324 A1 WO2013104324 A1 WO 2013104324A1 CN 2013070323 W CN2013070323 W CN 2013070323W WO 2013104324 A1 WO2013104324 A1 WO 2013104324A1
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Prior art keywords
branch
guiding catheter
guidewire
control
guide wire
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PCT/CN2013/070323
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English (en)
French (fr)
Inventor
朱清
黄定国
罗七一
高延彬
Original Assignee
上海微创医疗器械（集团）有限公司
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Publication date
Application filed by 上海微创医疗器械（集团）有限公司 filed Critical 上海微创医疗器械（集团）有限公司
Priority to BR112014017341-9A priority Critical patent/BR112014017341B1/pt
Priority to EP13736412.1A priority patent/EP2803340B1/en
Publication of WO2013104324A1 publication Critical patent/WO2013104324A1/zh

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Classifications

    • 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
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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
    • A61F2/82—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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0029—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0071—Multiple separate lumens
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • 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
    • 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
    • A61F2/856—Single tubular stent with a side portal passage
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91583—Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
    • 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
    • A61M2025/018—Catheters having a lateral opening for guiding elongated means lateral to the catheter
    • 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
    • A61M2025/0188—Introducing, guiding, advancing, emplacing or holding catheters having slitted or breakaway lumens
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1045—Balloon catheters with special features or adapted for special applications for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M25/0668—Guide tubes splittable, tear apart

Definitions

  • the present invention relates to medical devices, and more particularly to a guiding catheter for a branch-type stent delivery system for use in surgical treatment of aortic lesions.
  • the invention also relates to a branched stent delivery system comprising the guiding catheter. Background technique
  • aortic aneurysms involve multiple branch arteries of the aorta.
  • Stanford type A aortic dissection patients with lesions of the whole aorta are generally treated with median thoracotomy, using artificial blood vessels.
  • Most patients cannot complete the treatment in one operation. The second operation requires the chest to be opened under the left rib.
  • the mulch material on the intraoperative stent can be sutured with the artificial blood vessel used in the operation to complete a complete artificial vascular prosthesis replacement system, and achieve the purpose of completing all treatments in one operation.
  • Surgery with intraoperative stents not only completes all treatments in one operation, but also shortens the operation time and reduces the pain of the patient's secondary surgery.
  • Chinese invention patent application CN101332133A discloses a branch type stent or graft weaving device and a manufacturing method thereof, wherein a single weaving by a plurality of wires is performed A fabric having a trunk and two legs hinged to each other. The foot includes all of the plurality of wires, and the trunk portion includes a subset of the same plurality of wires.
  • the method of manufacture includes braiding the articulated foot on a mandrel and retaining a loop between the two articulated feet to braid the stem of the stent or graft.
  • the Chinese invention patent application CN101897629A relates to a branch type stent graft delivery system which discloses the delivery of a single-sided or single-branched integral stent. This delivery system does not address the problem of safe release during multi-branch stent delivery. In the case of a multi-branch stent, the system is unable to ensure that the multiple branch guide wires do not entangle and interfere with each other during delivery and allow each branch guidewire to smoothly enter the corresponding branch vessel lumen. Summary of the invention
  • an object of the present invention is to solve the problem of transporting a branch stent safely and smoothly to a lesion site of a corresponding branch vessel in a minimally invasive surgery of a thoracic aorta and a plurality of branch arteries.
  • a guiding catheter for a branch-type stent delivery system for guiding a branching guidewire into a corresponding branch vessel lumen smoothly for subsequent safe traction of the stent branch of the branch stent Enter the corresponding branch vessel lumen.
  • the guiding catheter has at least one branching guidewire lumen extending in the axial direction for guiding the branching guidewire, each branching guidewire lumen having a branching guidewire inlet and a corresponding branching guidewire outlet, and
  • the guiding catheter is axially split between the branch guidewire inlet and the branching guidewire outlet of each branch guidewire lumen to form a slit through which each branch guidewire can exit the guiding catheter. In this way, the catheter can be separated from the guidewire with the proximal and distal ends simultaneously unable to withdraw the catheter.
  • a branched stent has three stent branches for the three branch arteries of the aorta. therefore.
  • the guiding catheter has three branching guidewire lumens, each guiding a branching guidewire. Each lumen is not in communication with each other.
  • the guiding catheter is made of a polymer composite material or a metal material, or a composite structural tube.
  • the guiding catheter can be constructed as a double or multi-layered tubular member comprising an inner tubular member and an outer tubular member, the inner and outer tubular members being disposed along the axis between the branch guide wire inlet and the branch guide wire outlet of each branch guide wire lumen Cut open to form an incision.
  • the guiding catheter can also be constructed as a single tube. According to the invention, the slit is of a linear type, a virtual knife type or a groove type.
  • the guiding catheter can be a combined split tubular member defining a slit at the junction of the split portions of the tubular member.
  • the guiding catheter is provided with a development mark at each branch wire outlet. This can facilitate accurate positioning during surgery.
  • the guiding catheter may further comprise a control guidewire lumen extending axially for guiding the control guidewire.
  • the guiding catheter is also axially cut away on the extension of the control guidewire lumen to form a slit through which the control guidewire can exit the guiding catheter.
  • the slit can be linear, virtual or grooved.
  • the junction of the split portion also defines a slit that allows the control guidewire to pass away from the guiding catheter.
  • a branch-type stent delivery system comprising the above-described guiding catheter.
  • the branch type stent delivery system further includes a manipulation handle, an outer sheath, a branching bracket, a control guidewire for introducing and releasing the branching bracket, and a control switch, the branching bracket being coupled to the control guidewire and including at least one stent branch, and the system includes a branch guide for pulling the stent branch wire.
  • control handle and the control switch are controlled such that the guiding catheter is first introduced until the branch guide wire outlets are aligned with the corresponding branch vessels, and then the branching guide wire is guided into the corresponding branch vessel lumen through the guiding catheter, and then The branching guide wire is retained in the branch vessel lumen to separate the guiding catheter from the branching guidewire, and then the branching stent is introduced through the control guidewire, so that the stent branch is pulled through the branching guide wire to the corresponding branch vessel lumen. Finally, the branch guide is released by controlling the guide wire and the branch guide wire and the control guide wire are withdrawn. According to the present invention, the guiding catheter can be withdrawn after separation from the branching guidewire, and the control guidewire can be introduced separately through the additional catheter.
  • the joystick and the control switch are controllable such that both the branch guide wire and the control guide wire are guided through the guiding catheter into the corresponding aortic lumen and the branch artery lumen, and then the branch guide wire and the control guide
  • the guide catheter is separated from the branch guidewire and the control guidewire while the filament remains in the lumen of each vessel.
  • the control guidewire and the branch guidewire can be introduced simultaneously or at different times.
  • the guiding catheter and stent delivery system according to the present invention ensures that the branching guidewires do not entangle and interfere with each other during delivery, and that each branching guidewire can be smoothly and safely accessed into the corresponding branching vessel lumen.
  • the branch guide wire is first introduced into the branch vessel lumen through the guiding catheter, thereby establishing a passage for the traction stent branch.
  • the stent branches can be safely and smoothly transported along the established channel into their respective branch vessel lumens.
  • FIG. 1 is a schematic view showing the construction of a stent delivery system and a guiding catheter according to the present invention.
  • 1A-1B are partial enlarged views of a guiding catheter in accordance with the present invention.
  • 2-2A is a schematic and partial enlarged view of a guiding catheter in the form of a single tubular member.
  • Figure 3-3A is a schematic and partial enlarged view of a guiding catheter in the form of a double tube.
  • 4A-4C are schematic illustrations of the type of incision of the guiding catheter.
  • Figures 5A-4C are schematic illustrations of the type of incision in the case where the guidewire lumen is also provided with a slit.
  • Figure 6 is a schematic illustration of a guide catheter in the form of a combined split tubing.
  • Figure 7 is a schematic illustration of the introduction of a branch guidewire into a branch vessel lumen through a guiding catheter.
  • Figure 8 is a schematic illustration of the stent branch being pulled into the branch vessel lumen by a branching guidewire.
  • Figure 9 is a schematic illustration of the stent after release. List of reference signs
  • the branch stent has three stent branches for three branch arteries.
  • the guiding catheter has three branching guidewire lumens, each lumen guiding a branching guidewire to draw three stent branches, respectively.
  • the number of branch guidewire lumens can vary with stent branching. In the case of only one stent branch or two stent branches, there may be only one or two branch guidewire lumens.
  • the guiding catheter has a control guidewire lumen.
  • control guidewire can be guided through the additional catheter into the aortic lumen.
  • control guidewire and the branch guidewire can be introduced simultaneously or at different times.
  • distal and near end are used herein, and the end near the operating end (ie, the joystick 1) is the proximal end, and the end away from the operating handle 1 is far.
  • the stent delivery system of the present invention includes an operating handle 1, a control guidewire 2, a control switch 3, an outer sheath 4, and branching guide wires 5, 6, and 7.
  • the outer sheath 4 is made of a flexible polymer material such as PET or PTFE.
  • the restrained releasable branching stent 9 is completely or semi-fully wrapped by the outer sheath 4.
  • the outer sheath 4 can be constructed as a multilayer sheath as described in the applicant's Chinese patent application CN101897629A.
  • the bracket 9 has three bracket branches 10, 11, 12, and the bracket body and the bracket branch are respectively connected with the control guide wire 2 and the branch guide wires 5, 6, 7 to be pulled, and the bracket branch and the bracket body are controlled by operation.
  • the guiding catheter 8 has three branch wire inlets a, b, c at the proximal end and three branch wire outlets d, e, f, three branches at the distal end.
  • the guide wires 5, 6, 7 can be introduced from the inlet and exported from the outlet.
  • the exit is also provided with a development mark (not shown) to facilitate accurate positioning.
  • the guiding catheter 8 is made of polymer composite material or metal material) Or a tubular member constructed as a composite structure. As shown in Fig.
  • the guiding catheter 8 has a conical head 20 at the distal end to facilitate introduction into the aortic vessel, and it is axially sectioned between the branch guidewire inlet and outlet of each branching guidewire lumen. Open, forming a slit.
  • the guiding catheter 8 also has a control guidewire lumen (not shown) to guide the control guidewire 2.
  • the guiding catheter 8 is a single tube.
  • the guiding catheter 8 can be a double-layered tubular member, as shown in Fig. 3-3A, wherein the inner and outer tubular members are axially cut along the branch guide wire inlet and outlet of each branching guidewire lumen to form a slit. .
  • FIG 3A depicts the branch guidewire withdrawing from the incision 30.
  • the slit may be a linear slit 100, as shown in Fig. 4A, which may be a virtual knife-shaped slit 100', as shown in Fig. 4B, may be a slotted slit 100", as shown in Fig. 4C.
  • the virtual knife-shaped slit refers to A series of intermittent tear lines are formed along the axial direction of the guiding catheter 8. When the branching guide wire is separated from the guiding catheter, the through slit can be easily formed by breaking the tear line.
  • the guiding catheter 8 is in the control guide wire.
  • the extension of the lumen can also be cut axially to form a slit, as shown in Figures 5A-5C.
  • the slit can also be a linear slit 200, a virtual knife-shaped slit 200', a slotted slit 200".
  • the guiding catheter may be configured to combine the split tubular members 8', as shown in Fig. 6, the slits being formed at the junction of the split portions of the tubular members.
  • the tubular member 8' also has a tapered head 20'.
  • a development mark may be provided at the exit of the branch guide wire to facilitate precise positioning.
  • the branch guide wires 5, 6, and 7 are respectively introduced from the respective guide wire inlets a, b, c of the guiding catheter 8 until the branch guide wires 5, 6, 7 are derived from the branch guide wires P d, e, f , As shown in Figure 1.
  • the branch guide wires 5, 6, and 7 are respectively introduced into the corresponding branch vessel lumens, As shown in Figure 7.
  • the control guide wire 2 can be introduced simultaneously with the branch guide wire through the guiding catheter 8.
  • the branch guide wires 5, 6, 7 are retained in the respective branch vessel lumens, while the branch guides 5, 6, 7 are separated from the guiding catheter 8 by corresponding incisions to withdraw the guiding catheter 8 in vitro.
  • the branch guide wires reach the desired blood vessel position without being entangled and interfered with each other.
  • the control guidewire 2 can also be separated from the guiding catheter 8 by a corresponding incision.
  • the branching stent 9 is then delivered into position by the catheter of the branching stent and the control guidewire 2, wherein the stent branches 10, 11, 12 are drawn into the corresponding branch vessel lumen by the branching guidewires 5, 6, 7 As shown in Figure 8. Thereafter, the branch type stent 9 is released by controlling the guide wire 2, and then the branch guide wires 5, 6, 7 and the control guide wire 2 are withdrawn as shown in FIG.
  • the branch guidewire can be withdrawn from the aortic branch vessel and withdrawn from the distal end.
  • the outer sheath 4 is withdrawn from the body to complete the stent implantation operation.
  • the guiding catheter 8 of the present invention it is ensured that the plurality of branching guide wires 5, 6, 7 are not entangled with each other during the delivery process, and that the branching guide wires are prevented from entering the corresponding branching blood vessel lumen.
  • the stent branch is introduced along the established channel of the branch guide wire, thereby allowing the branch stent 9 to be safely and smoothly delivered to the lesion site of the aorta vessel and the plurality of branch arteries, and the stent 9 is safely released.
  • the guiding catheter and delivery system provided by the invention are not only suitable for the delivery of aortic branching stents, but also for the delivery of branching stents of other blood vessels.
  • the present invention is by no means limited to the specific contents described in the above detailed description. Other variations, modifications, and additions will occur to those skilled in the art without departing from the scope of the invention.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

一种用于分支型支架输送系统的导引导管（8，8'）及分支型支架输送系统，所述导引导管（8，8'）用来引导分支导丝（5，6，7）进入相应的分支血管腔内，以便随后牵引分支型支架（9）的支架分支（10，11，12）进入其相应的分支血管腔内，其特征在于，所述导引导管（8，8'）具有沿轴向延伸的至少一个分支导丝管腔，用于引导所述分支导丝（5，6，7），每个分支导丝管腔具有分支导丝入口（a，b，c）及相应的分支导丝出口（d，e，f），并且所述导引导管（8，8'）在各分支导丝管腔的分支导丝入口（a，b，c）和分支导丝出口（d，e，f）之间沿轴向剖开，形成切口（30，100，100'，100''），各分支导丝（5，6，7）能够通过该切口（30，100，100'，100''）而离开导引导管（8，8'）。

Description

分支型支架输送系统及用于其的导引导管 技术领域
本发明涉及医疗器械， 更具体涉及一种用于外科手术治疗主动脉 病变所使用的分支型支架输送系统的导引导管。 本发明还涉及包括该 导引导管的分支型支架输送系统。 背景技术
在临床上，主动脉瘤有相当一部分涉及到主动脉的多个分支动脉。 在传统的治疗中， 对患有全程主动脉 （包括升主动脉， 主动脉弓部， 降主动脉和腹主动脉）病变的 Stanford A型主动脉夹层病人一般采用正 中开胸手术治疗， 用人造血管进行升主动脉弓部的替换并在降主动脉 真腔中送入一段人造血管 （俗称象鼻子） ， 以便为二次手术或二次介 入治疗 （覆膜支架植入术） 作准备。 大多数患者一次手术并不能完成 治疗， 二次手术要从左肋下开胸， 手术风险大， 费用高， 且有一定的 衔接难度。 这种传统的人工血管置换术极为复杂、 创伤非常大、 死亡 率极高， 因而有必要用微创的方法治疗。 近年来出现了一种术中支架， 其可有效解决上面所述的二次手术 的问题， δΡ : —次手术完成全部治疗。 在手术中， 通过已切开的主动 脉直接将覆膜支架送入不能暴露的降主动脉真腔中， 从而达到治疗目 的。 术中支架上的覆膜材料可与手术中所使用的人造血管缝合在一起， 从而完成一套完整的人工血管假体置换系统， 达到一次手术完成全部 治疗的目的。 采用术中支架进行手术， 不仅一次手术完成全部治疗， 而且缩短了手术时间， 减轻了患者的二次手术的痛苦。 中国发明专利申请 CN101332133A公开了一种分支型支架或移植 物编织装置及其制造方法， 其中通过一单个由多根丝进行整体编织而 成的织物， 其具有一主干部和两个相互铰接的脚。 所述脚包括多根丝 的全部， 而所述主干部包括同一多根丝的一子集。 所述制造方法包括 在一心轴上编织所述铰接的脚， 并保持两铰接的脚之间的线环， 以便 编织所述支架或移植物的主干。 但是， 在目前的胸主动脉及多个分支动脉微创手术中， 如何将多 分支支架的各分支支架安全而又顺畅地输送到相应的分支血管腔内的 病变位置以便安全释放支架是一个难题。 中国发明专利申请 CN101897629A涉及一种分支型覆膜支架输送 系统， 其公开了单侧支或单分支整体支架的输送。 这一输送系统无法 解决多分支支架输送过程中的安全释放的问题。 在多分支支架的情况 下， 该系统无法确保多根分支导丝在输送过程不相互缠绕、 不干涉以 及使各分支导丝顺利进入相应的分支血管腔内。 发明内容
有鉴于此， 本发明的目的是解决涉及在胸主动脉及多个分支动脉 微创手术中将分支型支架安全而又顺畅地输送到相应的分支血管的病 变位置这一难题。 根据本发明第一方面， 提供一种用于分支型支架输送系统的导引 导管， 其用来引导分支导丝顺利地进入相应的分支血管腔内， 以便随 后安全地牵引分支型支架的支架分支进入相应的分支血管腔内。 所述 导引导管具有沿轴向延伸的至少一个分支导丝管腔， 用于引导所述分 支导丝， 每个分支导丝管腔具有分支导丝入口及相应的分支导丝出口， 并且所述导引导管在各分支导丝管腔的分支导丝入口和分支导丝出口 之间沿轴向剖开， 形成切口， 各分支导丝能够通过该切口而离开导引 导管。 以此方式， 能够在近端与远端同时不能撤回导管的情况下使导 管与导丝分离。 通常， 分支型支架具有三个支架分支， 以用于主动脉的三个分支 动脉。 因此。 导引导管具有三个分支导丝管腔， 每个管腔引导一根分 支导丝。 各管腔彼此互不连通。 导引导管由高分子复合材料或金属材料制成， 或者为复合结构的 管件。 所述导引导管可构成为双层或多层管件， 其包括内层管件和外 层管件， 内外层管件均在各分支导丝管腔的分支导丝入口和分支导丝 出口之间沿轴向剖开以形成切口。 导引导管也可构成为单个管件。 根 据本发明， 切口为线型， 虚刀型或槽型。 或者， 导引导管可为组合分体型管件， 在管件的分体部分的接合 处限定出切口。 优选地， 所述导引导管在各分支导丝出口设有显影标记。 这样可 以便于手术时准确定位。 根据本发明， 所述导引导管可还包括沿轴向延伸的控制导丝腔， 用于引导控制导丝。 优选地， 所述导引导管在控制导丝管腔的延伸上也沿轴向剖开， 形成切口， 所述控制导丝能够通过该切口而离开所述导引导管。 切口 可为线型， 虚刀型或槽型。 在导引导管为组合分体型管件时， 在分体部分的接合处还限定出 使所述控制导丝能够通过而离开所述导引导管的切口。 根据本发明第二方面， 提供一种分支型支架输送系统， 其包括上 述的导引导管。 根据本发明， 所述分支型支架输送系统还包括操纵手柄、 外鞘、 分支型支架、 用以导入和释放分支型支架的控制导丝及控制开关， 所 述分支型支架与控制导丝相连并包括至少一个支架分支， 且所述系统 包括用以牵引支架分支的分支导丝。 其中控制操纵手柄和控制开关， 使得先将导引导管导入， 直至各分支导丝出口对准相应的分支血管， 再通过导引导管将分支导丝引导进入相应的分支血管腔内， 然后在将 分支导丝保留于分支血管腔内的情况下使导引导管与分支导丝分离， 之后通过控制导丝将分支型支架导入， 使支架分支通过分支导丝而被 牵引至其相应的分支血管腔内， 最后通过控制导丝释放分支型支架并 撤出分支导丝和控制导丝。 根据本发明， 导引导管可在与分支导丝分离后撤出， 而控制导丝 可通过另外的导管单独地导入。 优选地， 可控制操纵手柄和控制开关， 使得分支导丝和控制导丝 均通过导引导管而引导进入相应的主动脉血管腔内和分支动脉血管腔 内， 然后在将分支导丝和控制导丝保留于各血管腔内的情况下使导引 导管与分支导丝和控制导丝分离。 根据本发明， 控制导丝和分支导丝可以同时或不同时导入。 根据本发明的导引导管和支架输送系统能确保分支导丝在输送过 程不相互缠绕、 不干涉， 并且能确保各分支导丝顺利而又安全地进入 相应的分支血管腔内。 而且， 根据本发明， 先通过导引导管将分支导 丝引入分支血管腔内， 从而建立了牵引支架分支的通道。 以此方式， 支架分支可沿已建好的通道安全而又顺畅地输送至其相应的分支血管 腔内。 附图说明
图 1是根据本发明的支架输送系统和导引导管的构造示意图。 图 1A-1B是根据本发明的导引导管的局部放大视图。 图 2-2A是单个管件形式的导引导管的示意图和局部放大视图。 图 3-3A是双层管件形式的导引导管的示意图和局部放大视图。 图 4A-4C是导引导管的切口类型的示意图。
图 5A-4C是控制导丝管腔也具有切口的情况下的切口类型的示意 图。
图 6是组合分体型管件形式的导引导管的示意图。
图 7是通过导引导管将分支导丝引入分支血管腔内的示意图。 图 8 是通过分支导丝将支架分支牵引进入分支血管腔内的示意 图。
图 9是支架释放后的示意图。 附图标记列表
1 操纵手柄
2 控制导丝
3 控制开关
4 外鞘
5、 6、 7 分支导丝
8、 8' 导引导管
9分支型支架
10、 11、 12 支架分支
20、 20' 导引导管的锥形头
30 分支导丝撤出切口
100、 200 线型切口
100，、 200， 虚刀型切口
100"、 200" 槽型切口
a、 b、 c 分支导丝入口
d、 e、 f 分支导丝出口 具体实施方式
下面结合附图对本发明的具体实施方式进行详细说明。 在以下实施例中， 分支型支架具有三个支架分支， 用于三个分支 动脉。 因此， 导引导管具有三个分支导丝管腔， 每个管腔引导一根分 支导丝， 以分别牵引三个支架分支。 但是， 本领域技术人员可以理解， 分支导丝管腔的数量可以随着支架分支变化。 在只有一个支架分支或 两个支架分支的情况下， 可以只有一个或两个分支导丝管腔。 而且， 在以下实施例中， 导引导管具有控制导丝管腔。 但是， 本 领域技术人员可以理解， 控制导丝可以通过另外的导管来引导进入主 动脉血管腔内。 而且， 控制导丝和分支导丝可以同时或不同时导入。 另外， 为了便于描述， 这里使用了术语 "远端" 和 "近端" ， 离 操作端 （即操纵手柄 1 )近的一端为近端， 远离操作手柄 1的一端为远
4山
如图 1所示，本发明的支架输送系统包括操作手柄 1，控制导丝 2， 控制开关 3， 外鞘 4， 分支导丝 5、 6、 7， 导引导管 8。 外鞘 4由 PET、 PTFE等柔性高分子材料制成。 束缚可释放的分支型支架 9由外鞘 4完 全或半完全包裹。 作为选择， 外鞘 4 可构成为多层鞘管， 如申请人的 中国发明专利申请 CN101897629A中所述。 支架 9具有三个支架分支 10、 11、 12， 支架主体和支架分支分别 与控制导丝 2和分支导丝 5、 6、 7相连， 以便被牵引， 且支架分支和 支架主体均通过操作控制导丝 2来释放。通过操纵手柄 1和控制开关 3， 可以对各导丝进行操作。 上述是本领域技术人员熟知的。 再来看图 1A-1B , 如图所示， 导引导管 8在近端具有三个分支导 丝入口 a、 b、 c， 在远端具有三个分支导丝出口 d、 e、 f， 三根分支导 丝 5、 6、 7 可从入口导入， 从出口导出。 出口还设有显影标记 （未示 出） ， 以便于准确定位。 导引导管 8 由高分子复合材料或金属材料)制 成， 或构成为复合结构的管件。 如图 2-2A所示， 导引导管 8在远端具有锥形头 20， 以促进导入 主动脉血管， 且其在各分支导丝管腔的分支导丝入口和出口之间沿轴 向剖开， 形成切口。 导引导管 8 还具有控制导丝管腔 （未标出） ， 以 引导控制导丝 2。 在该情形中， 导引导管 8为单个管件。 作为选择， 导 引导管 8可为双层管件， 如图 3-3A所示， 其中内外层管件均在各分支 导丝管腔的分支导丝入口和出口之间沿轴向剖开， 形成切口。 图 3A标 出了分支导丝撤出切口 30。 切口可为线型切口 100， 如图 4A所示， 可为虚刀型切口 100'， 如 图 4B所示， 可为槽型切口 100"， 如图 4C所示。 虚刀型切口指的是沿 导引导管 8 的轴向形成一系列断续的撕裂线。 在使分支导丝与导引导 管分离时， 可容易地通过打破撕裂线形成贯穿切口。 导引导管 8在控制导丝管腔的延伸上也可沿轴向剖开，形成切口， 如图 5A-5C所示。 切口也可为线型切口 200， 虚刀型切口 200'， 槽型 切口 200"。 作为选择， 导引导管可以构成为组合分体型管件 8'， 如图 6所示， 切口在管件的分体部分的接合处形成。 管件 8'也具有锥形头 20'。 下面参照图 7-9 对本发明的分支型支架输送系统的操作方法说明 如下。 首先， 将导引导管 8从人体髂动脉导入， 直至导引导管 8 的各 分支导丝出口 d、 e、 f与相应的分支血管分别对准。 分支导丝出口处可 以设有显影标记， 以便于精确定位。 然后， 从导引导管 8的各分支导丝入口 a、 b、 c分别导入分支导 丝 5、 6、 7， 直至分支导丝 5、 6、 7从分支导丝出 P d、 e、 f导出， 如 图 1所示。 进一步将分支导丝 5、 6、 7分别导入相应的分支血管腔内， 如图 7所示。 控制导丝 2可以通过导引导管 8与分支导丝同时导入。 然后， 保留分支导丝 5、 6、 7在相应的分支血管腔内， 同时使分 支导丝 5、 6、 7通过相应的切口而与导引导管 8与分离， 以便将导引 导管 8 撤出体外。 由此， 分支导丝到达期望的血管位置， 而不会相互 缠绕和干涉。 控制导丝 2也可通过相应的切口而与导引导管 8与分离。 然后， 通过分支型支架的导管和控制导丝 2将分支型支架 9输送 到位， 其中使支架分支 10、 11、 12通过分支导丝 5、 6、 7而被牵引至 相应的分支血管腔内， 如图 8所示。 之后，通过控制导丝 2释放分支型支架 9，之后撤出各分支导丝 5、 6、 7和控制导丝 2， 如图 9所示。 分支导丝可从主动脉分支血管穿出， 从远端撤出。 最后将外鞘 4撤出体外， 完成支架植入手术。 通过本发明的导引导管 8， 确保了多根分支导丝 5、 6、 7在输送 过程不相互缠绕、 不干涉， 并且能确保分支导丝进入相应的分支血管 腔。 而且， 支架分支沿着分支导丝已建好的通道引入， 由此使分支型 支架 9安全、 顺畅输送至主动脉血管及多个分支动脉血管的病变位置， 并将支架 9安全地释放。 本发明所提供的导引导管及输送系统不仅适合用于主动脉分支型 支架的输送， 也适合用于其他血管的分支型支架的输送。 本发明决不局限于上述具体实施方式中所描述的具体内容。 本领 域技术人员可以想到其它变型、 修改和增加， 而不会离开本发明的范 围。

Claims

1. 一种用于分支型支架输送系统的导引导管 （8) ， 其用来引导 分支导丝 （5、 6、 7) 进入相应的分支血管腔内， 以便随后牵引分支型 支架 （9) 的支架分支 （10、 11、 12) 进入其相应的分支血管腔内， 其 特征在于， 所述导引导管 （8) 具有沿轴向延伸的至少一个分支导丝管 腔， 用于引导所述分支导丝 （5、 6、 7) ， 每个分支导丝管腔具有分支 导丝入口 （a、 b、 c) 及相应的分支导丝出口 （d、 e、 f) ， 并且所述导 引导管 （8) 在各分支导丝管腔的分支导丝入口和分支导丝出口之间沿 轴向剖开， 形成切口， 各分支导丝 （5、 6、 7) 能够通过该切口而离开 导引导管 （8) 。
2. 如权利要求 1所述的导引导管 （8) ， 其中， 所述导引导管 （8) 构成为双层或多层管件， 其包括内层管件和外层管件， 内外层管件均 在各分支导丝管腔的分支导丝入口和分支导丝出口之间沿轴向剖开以 形成切口。
3. 如权利要求 1所述的导引导管 （8) ， 其中， 所述导引导管 （8) 构成为单个管件。
4. 如权利要求 1所述的导引导管 （8) ， 其中， 所述导引导管 （8) 为组合分体型管件 （8') ， 在分体部分的接合处限定出所述切口。
5. 如权利要求 1-3中任一项所述的导引导管 （8) ， 其中， 所述切 口为线型（100; 200)， 虚刀型（100， ； 200，）或槽型（100，， ； 200") 。
6. 如权利要求 1-4中任一项所述的导引导管 （8) ， 其中， 所述导 引导管 （8) 在各分支导丝出口 （d、 e、 f) 设有显影标记。 7. 如权利要求 1-3中任一项所述的导引导管 （8) ， 其中， 所述导 引导管（8)还包括沿轴向延伸的控制导丝腔， 用于引导控制导丝（2)。
8. 如权利要求 7所述的导引导管 （8) ， 其中， 所述导引导管 （8) 在控制导丝管腔的延伸上沿轴向剖开， 形成切口， 所述控制导丝 （2) 能够通过该切口而离开所述导引导管 （8) 。
9. 如权利要求 8 所述的导引导管 （8) ， 其中， 所述切口为线型 (200) ， 虚刀型 （200，） 或槽型 （200，，） 。 10. 如权利要求 4所述的导引导管（8)， 其中， 所述导引导管（8) 还包括沿轴向延伸的控制导丝腔， 用于引导控制导丝 （2) ， 在分体部 分的接合处还限定出使所述控制导丝 （2) 能够通过而离开所述导引导 管 （8) 的切口。 11. 一种分支型支架输送系统， 其特征在于， 所述分支型支架输 送系统包括如权利要求 1-10中任一项所述的导引导管 （8) 。
12. 如权利要求 11所述的分支型支架输送系统， 其还包括操纵手 柄 （1) 、 外鞘 （4) 、 分支型支架 （9) 、 用以导入和释放分支型支架 (9) 的控制导丝 （2) 及控制开关 （3) ， 所述分支型支架 （9) 与控 制导丝 （2) 相连并包括至少一个支架分支 （10， 11， 12) ， 且所述系 统包括用以牵引支架分支 （10、 11、 12) 的分支导丝 （5、 6、 7) ， 其 中控制操纵手柄 （1) 和控制开关 （3) ， 使得先将导引导管 （8) 导入， 直至各分支导丝出口对准相应的分支血管， 再通过导引导管 （8) 将分 支导丝 （5、 6、 7) 引导进入相应的分支血管腔内， 然后在将分支导丝 保留于分支血管腔内的情况下使导引导管 （8) 与分支导丝 （5、 6、 7) 分离， 之后通过控制导丝 （2) 将分支型支架 （9) 导入， 使支架分支 (10、 11、 12) 通过分支导丝 （5、 6、 7) 而被牵引至其相应的分支血 管腔内， 最后通过控制导丝 （2) 释放分支型支架 （9) 并撤出分支导 丝 （5、 6、 7) 和控制导丝 （2) 。
13. 如权利要求 12所述的分支型支架输送系统， 其中， 控制操纵 手柄 （1)和控制开关（3) ， 使得分支导丝 （5、 6、 7)和控制导丝 （2) 均通过导引导管 （8) 而引导进入相应的血管腔内， 然后在将分支导丝 和控制导丝保留于血管腔内的情况下使导引导管 （8) 与分支导丝 （5、
6、 7) 和控制导丝 （2) 分离。
PCT/CN2013/070323 2012-01-12 2013-01-10 分支型支架输送系统及用于其的导引导管 WO2013104324A1 (zh)

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