WO2023165261A1 - Appareil de pose et système d'endoprothèse - Google Patents

Appareil de pose et système d'endoprothèse Download PDF

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Publication number
WO2023165261A1
WO2023165261A1 PCT/CN2023/070824 CN2023070824W WO2023165261A1 WO 2023165261 A1 WO2023165261 A1 WO 2023165261A1 CN 2023070824 W CN2023070824 W CN 2023070824W WO 2023165261 A1 WO2023165261 A1 WO 2023165261A1
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Prior art keywords
branch
sheath
delivery device
guide wire
section
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PCT/CN2023/070824
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English (en)
Chinese (zh)
Inventor
刘金宏
奚利峰
马明洁
卞其波
徐健伟
朱清
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上海微创心脉医疗科技(集团)股份有限公司
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Publication of WO2023165261A1 publication Critical patent/WO2023165261A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord

Definitions

  • the present application relates to the technical field of medical devices, in particular to a delivery device and a stent system.
  • Aortic disease such as aortic aneurysm and aortic dissection
  • aortic aneurysm and aortic dissection is one of the most deadly and difficult vascular surgical diseases.
  • the endovascular repair (EVAR) of aortic dissection with covered metal stents is a new method developed in recent years.
  • EVAR endovascular repair
  • the common complications associated with EVAR treatment include graft-to-graft endoleak and graft displacement.
  • bifurcated covered stents (including stented left leg and stented right leg) can be used for treatment
  • the bifurcated covered stent graft is sent to the lesion position of the aorta through the incision of the left and right femoral arteries through the delivery device, so as to protect the diseased blood vessel and repair the aortic lesion.
  • the structural feature of the bifurcated stent-graft is that it includes the left leg of the stent and the right leg of the stent at the same time. Since the left leg of the stent and the right leg of the stent exist at the same time, the outer diameters of the outer sheath tubes in the delivery device suitable for the bifurcated stent-graft are relatively the same.
  • a larger incision needs to be made on the femoral artery during the delivery process, resulting in greater trauma to the patient and high requirements for the patient's femoral artery, resulting in the applicable
  • the number of patients is small, the scope of indications is small, and the large-diameter delivery device is difficult to adapt to the movement in the blood vessel, and the operation is laborious and complicated for the doctor to use.
  • the present application provides a delivery device for delivering a bifurcated stent, the delivery device comprising:
  • the branch sheath is used to bind the branch section of the bifurcated stent, the branch sheath is provided with a branch sheath control guide wire, and the branch sheath control guide wire is configured to withdraw the branch Sheath;
  • a multi-lumen tube has a fixed lumen and a guiding lumen axially penetrating through it.
  • the multi-lumen tube includes a main body section and a diameter-reducing section located at the distal end of the main body section.
  • the diameter of the diameter-changing section is smaller than the diameter of the main body section.
  • an accommodation gap is formed between the outer wall of the variable diameter section and the inner wall of the outer sheath tube, so that the branch sheath control guide wire can be folded back in the accommodation gap, and the guide lumen is configured for passing through stent control guidewire;
  • An inner catheter the inner catheter is sleeved in the fixed cavity and fixed relatively to the multi-lumen tube, wherein the distal end of the inner catheter protrudes from the distal end of the multi-lumen tube, and the multi-lumen tube and the inner catheter are movably arranged in the inner lumen of the outer sheath along the axial direction of the outer sheath.
  • the radial distance between the outer wall of the main body section and the inner wall of the outer sheath is smaller than the diameter of the branch sheath control guide wire.
  • the radial distance between the outer wall of at least a part of the reducing section and the inner wall of the outer sheath is greater than the diameter of the branch sheath control guide wire.
  • the diameter of the diameter reducing section decreases gradually from the proximal end to the distal end.
  • the minimum diameter of the variable diameter section is larger than the diameter of the inner catheter, and the distal end of the variable diameter section is configured to be able to resist the bifurcated stent in a contracted state.
  • the axis of the fixed lumen coincides with the axis of the multi-lumen tube, and the multi-lumen tube is assembled coaxially with the inner catheter.
  • the outer wall of the outer sheath is provided with a hydrophilic coating.
  • the number of the guide lumens is two, the two guide lumens are isolated from each other, the stent control guide wire includes a restraint guide wire and a release guide wire, and the two guide lumens are respectively used for binding A guide wire and a release guide wire are passed through, and the restraint guide wire is configured to restrain the main frame segment and one of the branch segments of the bifurcated stent to a contracted state or release to an expanded state; the release guide wire configured for locking or releasing the bifurcated stent to the inner catheter.
  • the branch sheath is further provided with a binding member, and the branch sheath is configured to bind the other branch section of the bifurcated stent to a contracted state or to release it to an expanded state , the tethering member is configured for connecting the tethering guidewire.
  • the proximal end of the branch sheath has a tapered section.
  • the binding member is connected to the distal end of the branch sheath
  • the branch sheath control guide wire is connected to the proximal end of the branch sheath
  • a developing element is also provided.
  • the delivery device further includes:
  • a guide head is arranged at the distal end of the inner catheter, the guide head has an axially penetrating lumen, and the lumen of the guide head communicates with the inner lumen of the inner catheter.
  • the delivery device further includes:
  • the handle has an axially through inner cavity, the distal end of the handle is connected to the proximal end of the outer sheath, and the inner cavity of the handle communicates with the inner cavity of the outer sheath.
  • the present application provides a stent system, and the stent system includes the delivery device.
  • the stent system also includes:
  • a bifurcated stent configured to fit over the inner catheter.
  • FIG. 1 is a schematic structural diagram of a delivery device provided by some embodiments of the present application.
  • Fig. 2 is a partial structural schematic diagram of a delivery device provided by some embodiments of the present application.
  • Fig. 3 is a schematic structural diagram of a main body section and a variable diameter section provided by some embodiments of the present application;
  • Fig. 4 is a schematic structural diagram of a fixed cavity and a guide cavity provided by some embodiments of the present application.
  • Fig. 5 is a schematic structural view of a branch sheath, a binding member and a branch sheath control guide wire provided by some embodiments of the present application.
  • outer sheath tube 100, outer sheath tube; 200, multi-lumen tube; 300, inner catheter; 400, branch sheath tube; 500, guide head; 600, handle;
  • 210 main body section; 220, variable diameter section; 230, fixed cavity; 240, guide cavity;
  • the branch sheath controls the turning section of the guide wire.
  • distal end is defined here to mean the end away from the operator during the surgical operation
  • proximal end means the end close to the operator during the surgical operation.
  • the bifurcated stent 001 is a type of stent that can be covered with a membrane to become a bifurcated stent graft.
  • the bifurcated stent 001 includes a main frame section 002 and two branch sections 003 connected to the proximal end of the main frame section 002.
  • the two branch sections 003 can both be inclined relative to the axial direction of the main frame section 002, so that the main frame section 002 and the two branch sections 003 are connected to form a "Y" shape, or, wherein One of the branch sections 003 can extend along the axial direction of the main frame section 002 and remain coaxial with the main frame section 002, while the other branch section 003 is inclined relative to the axial direction of the main frame section 002, which can constitute a branch section.
  • the fork-shaped bracket 001 those skilled in the art can set the structure of the bifurcated bracket 001 according to requirements, which is not limited here.
  • an embodiment of the present application provides a delivery device for delivering a bifurcated stent 001
  • the bifurcated stent 001 includes a main frame section 002 and two branch sections 003, the The bifurcated stent 001 can be of the different types mentioned above or the type set by those skilled in the art according to the needs. Placed under the abdominal aorta, the two branch segments 003 of the bifurcated stent 001 can be respectively placed in the left and right iliac arteries to complete release. Of course, in addition, the bifurcated stent 001 can also be applied to similar The usage scenarios are not described and limited here.
  • the delivery device includes an outer sheath 100, a multi-lumen tube 200, an inner catheter 300, and a branch sheath 400.
  • the branch sheath 400 is provided with a branch sheath control guide wire 420, and the branch sheath control guide wire 420 is configured For retracting the branch sheath 400, the branch sheath 400 is used to bind the branch segments of the bifurcated stent.
  • the multi-lumen tube 200 has a fixed lumen 230 and a guide lumen 240 passing through in the axial direction.
  • the multi-lumen tube 200 includes a main body section 210 and a diameter-reducing section 220 located at the distal end of the main body section 210.
  • the diameter of the diameter-reducing section 220 is Smaller than the diameter of the main body section 210, an accommodation gap 231 is formed between the outer wall of the reduced diameter section 220 and the inner wall of the outer sheath tube 100, so that the branch sheath control guide wire 420 can be in the accommodation gap 231
  • the folded back part may be referred to as the folded section 421 of the branch sheath control guide wire 420 .
  • the guide lumen 240 is configured to pass through a stent control guide wire, the inner catheter 300 is sleeved in the fixing lumen 230 and relatively fixed with the multi-lumen tube 200 , wherein the distal end of the inner catheter 300 end protrudes from the distal end of the multi-lumen tube 200, and the multi-lumen tube 200 and the inner catheter 300 are simultaneously movably arranged in the inner lumen of the outer sheath tube 100 along the axial direction of the outer sheath tube 100 , the lumen of the inner catheter 300 is configured for passing a main guide wire.
  • the delivery device improves the structure of the multi-lumen tube 200, so that the multi-lumen tube 200 is no longer a straight tube with the same axial diameter, but a tube body structure with a main body section 210 and a variable diameter section 220.
  • the main body section 210 and the variable diameter section The diameter of the diameter section 220 is different, so when the multi-lumen tube 200 is axially assembled in the inner cavity of the outer sheath tube 100, the radial distance between the outer wall of the main body section 210 and the inner wall of the outer sheath tube 100 is different from that of the reducing section
  • the radial distance between the outer wall of 220 and the inner wall of the outer sheath 100 is different, and a relatively larger accommodation gap 231 can be formed between the outer wall of the reducing section 220 and the inner wall of the outer sheath 100, and the accommodation gap 231 Can be used to accommodate a branch sheath control guidewire 420 .
  • the main body section 210 and the reduced-diameter section 220 can be integrally formed, that is to say, the diameter of the part near the distal end of the multi-lumen tube 200 is smaller than that of other parts.
  • the main body section 210 and the reduced diameter section 220 may also be fixedly connected by means of welding or the like.
  • the main body section 210 and the reducing section 220 are integrally formed.
  • the branch sheath control guide wire 420 is located at the proximal end of the branch sheath 400, and at this time the branch sheath control guide wire 420 needs to be folded back 180 degrees, so that the branch sheath control guide wire 420 faces the distal end, and protrudes from the distal end of the outer sheath tube 100 to the outside of the outer sheath tube 100 .
  • the multi-lumen tube 200 is a straight tube
  • a sufficient radial gap must be reserved between the outer wall of the multi-lumen tube 200 and the inner wall of the outer sheath tube 100 to meet the 180-degree turnback of the branch sheath control guide wire 420, so that the branch
  • the turn-back section 421 of the sheath control guide wire 420 can have a space to be accommodated, which is one of the fundamental reasons why the outer diameter of the existing outer sheath tube is too large.
  • the accommodation gap 231 formed between the variable diameter section 220 of the multi-lumen tube 200 and the outer sheath tube 100 can provide accommodation for the branch sheath control guide wire 420, so that the folded section 421 formed when the branch sheath control guide wire 420 is folded back be accommodated in the accommodating gap 231, so that the maximum diameter of the outer sheath tube 100 can be effectively reduced without reducing the diameter of the multi-lumen tube 200, and the reduction of the maximum diameter of the outer sheath tube 100 means that the wound can be
  • the effective reduction makes the delivery device applicable to more patients and expands the scope of indications, and the reduced diameter of the delivery device can also be more suitable for moving in blood vessels, making it more convenient for doctors to use and easier to operate during surgery.
  • the outer diameter of the main body section 210 of the multi-lumen tube 200 can be set to 4.5mm to 5.2mm, and the outer diameter of the main body section 210 can be 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, 5.0mm, 5.1mm and 5.2mm.
  • the axial length of the variable diameter section 220 of the multi-lumen tube 200 can be set to 12mm to 15mm
  • the axial length of the variable diameter section 220 can be 12mm, 13mm, 14mm and 15mm
  • the variable diameter section 220 of the multi-lumen tube 200 The outer diameter of the diameter section 220 can be set to 3.3 mm to 4.0 mm
  • the outer diameter of the main body section 210 can be 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm and 4.0 mm.
  • the outer diameter of the outer sheath tube 100 can be set to 5.0mm to 6.0mm, and the outer diameter of the outer sheath tube 100 can be 5.1mm, 5.2mm, 5.3mm, 5.4mm, 5.5mm, 5.6mm, 5.7mm, 5.8mm, 5.9mm mm and 6.0mm, the inner diameter of the outer sheath 100 can be set to 4.9mm to 5.6mm, and the inner diameter of the outer sheath 100 can be 4.9mm, 5.0mm, 5.1mm, 5.2mm, 5.3mm, 5.4mm, 5.5mm , 5.6mm range.
  • the diameter of the branch sheath control guidewire 420 can be set to 0.8mm to 1.2mm, and the diameter of the branch sheath control guidewire 420 can be 0.8mm, 0.85mm, 0.9mm, 0.95mm, 1.0mm, 1.05mm, 1.1mm, 1.15mm and 1.2mm range.
  • Those skilled in the art can select the dimensions of each part of the multi-lumen tube 200, the outer sheath tube 100, and the branch sheath control guide wire 420 according to the requirements, so as to be able to form a match, and realize using the accommodation gap 231 to control the folded section 421 of the branch sheath control guide wire 420 To be accommodated, there is no limitation here.
  • the radial distance between the outer wall of the main body section 210 and the inner wall of the outer sheath tube 100 is smaller than the diameter of the branch sheath control guide wire 420 , at this time the outer wall of the main body section 210
  • the radial distance between the inner wall of the outer sheath tube 100 is small enough, and the branch sheath control guide wire 420 cannot squeeze into the gap between the outer wall of the main body section 210 and the inner wall of the outer sheath tube 100, thereby branching
  • the sheath control guide wire 420 can be easily turned back without getting stuck between the multi-lumen tube 200 and the outer sheath tube 100, and then the branch sheath control guide wire 420 is extended from the distal end of the outer sheath tube 100 to the outer sheath
  • the tube can be folded back 180 degrees and extended to the proximal end after 100 degrees, which can facilitate the operation of the doctor during the operation.
  • the radial distance between the outer wall of at least a part of the reducing section 220 and the inner wall of the outer sheath tube 100 can be controlled to be greater than the diameter of the branch sheath control guide wire 420, so
  • the accommodating gap 231 that allows the branch sheath control guide wire 420 to enter can be formed, and the diameter-reducing section 220 of the multi-lumen tube 200 can be in a gradual diameter change form, a stepped diameter change form, or a diameter change form.
  • the diameter of the variable diameter section 220 gradually decreases from the proximal end to the distal end, at this time, the distal end of the variable diameter section 220 can be easily inserted into the branch sheath Control the guide wire 420 until the branch sheath controls the guide wire 420 to extend into the proximal end, it will be restricted and cannot continue to advance in the proximal direction.
  • the section where the distal end of the inner catheter 300 protrudes from the distal end of the multi-lumen tube 200 is used to socket the bifurcated stent 001, and the length of this section is limited to be sufficient to socket the corresponding
  • the minimum diameter of the diameter-reducing section 220 is greater than the diameter of the inner catheter 300, and the distal end of the diameter-reducing section 220 is configured to abut against
  • the bifurcated stent 001 in the contracted state can make the bifurcated stent 001 abut against the distal end of the reducing section 220 , making the assembly of the bifurcated stent 001 more stable.
  • the axis of the fixed lumen 230 coincides with the axis of the multi-lumen tube 200, and the multi-lumen tube 200 is coaxially assembled with the inner catheter 300.
  • the inner catheter 300 is After the fixed cavity 230 is socketed and fixed relative to the multi-lumen tube 200, a certain degree of offset can also be formed in the radial direction, as long as the assembly of the bifurcated stent 001 can be ensured, the coaxiality of the two does not matter. Make strict limits.
  • the outer wall of the outer sheath 100 can be provided with a hydrophilic coating, and the smoothness of the delivery device in the blood vessel can be increased by coating the outer wall of the outer sheath 100 with a hydrophilic coating.
  • the number of the guide lumens 240 is two, the two guide lumens 240 are isolated from each other, the stent control guide wire includes a restraint guide wire and a release guide wire, the restraint guide wire and the guide wire
  • the release guide wires are respectively movably threaded in the two guide lumens 240, and the restraint guide wires are configured to restrain the main frame segment 002 and one of the branch segments 003 of the bifurcated stent 001 to contraction state or released to the expanded state, wherein, before the delivery device is sent into the diseased vessel, the main frame section 002 and one of the branch sections 003 of the bifurcated stent 001 can be sleeved on the distal end of the inner catheter 300, and tied
  • the guide wire binds the main frame section 002 and the branch section 003, so that the main frame section 002 and the branch section 003 are bound to the contracted state.
  • the guide wire is retracted and bound.
  • the restraint of the main frame section 002 and the branch sections 003 can be released, so that the main frame section 002 and the branch sections 003 are released to the expanded state.
  • the release guide wire is configured to lock the bifurcated stent 001 to the inner catheter 300 or release relative to the inner catheter 300, and the release guide wire is mainly used to finally release the entire bifurcated stent 001 , before the bifurcated stent 001 reaches the target position of the diseased blood vessel, the release guide wire needs to connect the bifurcated stent 001 to the distal end of the inner catheter 300, so that the bifurcated stent 001 moves along with the inner catheter 300 in the diseased blood vessel , when the bifurcated stent 001 reaches the target position of the diseased vessel and reaches the expanded state as a whole, the delivery device can be withdrawn to leave the bifurcated stent 001 in the diseased vessel. At this time, the guide wire can be released by withdrawing The bifurcated stent 001 is separated from the inner catheter 300, so that the bifurcated stent 001 is separated from the delivery device and left in the diseased blood vessel.
  • the number of guiding lumen 240 may also be one, and the stent control guidewire only needs to include a restraint guidewire. Or, both the binding guide wire and the release guide wire rely on the guide lumen 240 on the multi-lumen tube 200.
  • there may be multiple guide lumens 240 there may be multiple binding guide wires and multiple release guide wires. At this time, different binding guide wires and release guide wires may be respectively located in different guide lumens 240.
  • the number of the guide lumens 240 can be 2N, N is an integer, a plurality of the guide lumens 240 are evenly distributed along the circumference of the multi-lumen tube 200, the binding guide wire and the release guide wire The wires are passed through different guide cavities 240 respectively.
  • the branch sheath 400 is further provided with a binding member 410, and the branch sheath 400 is configured to bind the other branch section 003 of the bifurcated stent 001 to a contracted state or Released to the expanded state, the binding member 410 is connected to the branch sheath 400 , and the binding member 410 is configured to connect the binding guide wire so as to prevent the branch sheath from slipping off.
  • the tie piece 410 can be a wire-like piece, and the wire ends of the tie piece 410 can pass through the bifurcated stent 001 during assembly, and then form a connection with the tie guide wire that binds the bifurcated stent 001, preventing the branch sheath 400 from being in the bifurcated stent.
  • the branch sheath control guide wire 420 can fix one end of the branch sheath tube 400 during assembly, and the other end can be exposed outside the delivery device after being folded back, so that the operator can withdraw the branch sheath tube 400 and place the corresponding The branch section 003 of the bifurcated stent is released to the expanded state.
  • the binding member 410 Since the binding member 410 is connected to the binding guide wire, when the binding guide wire is retracted, the branch sheath control guide wire 420 will be retracted at the same time, and the main frame section 002 of the bifurcated stent 001 will be released at the same time. And two branch segments 003, effectively increasing the accuracy and safety of the operation.
  • the branch sheath 400 can be a film-coated tube body. After the branch sheath 400 is sleeved on the branch section 003, the corresponding branch section 003 can be bound to a contracted state, and can be connected with the main frame section 002 of the bifurcated stent 001 and the other branch section 003.
  • the branch section 003 is parallel compressed in the lumen of the outer sheath tube 100, and when the delivery device is introduced into the target position of the diseased blood vessel, it can assist the positioning of the bifurcated stent 001, increasing the accuracy and safety of the operation.
  • the proximal end of the branch sheath 400 has a tapered section 430, and the tapered section 430 can cooperate with the reducing section 220.
  • the proximal end of the branching sheath 400 approaches the reducing section 220 , it can prevent the proximal end of the branch sheath 400 from occupying the space of the accommodation gap 231 as much as possible, so as to prevent the branch sheath from controlling the folding back section 421 of the guide wire 420 in the accommodation gap 231 .
  • the binding member 410 can be connected to the distal end of the branch sheath 400 to facilitate the connection of the binding member 410 with the binding guide wire on the bifurcated stent 001, and the branch sheath control guide wire 420 can be connected to the The proximal end of the branch sheath 400 is convenient for the branch sheath to control the guide wire 420 to extend proximally so as to be folded back in the accommodation gap 231 .
  • the proximal end of the branch sheath control guide wire 420 is also provided with a development element 440, the development element 440 can be as close as possible to the branch sheath 400, and the development element 440 can adopt a structure suitable for being arranged on the branch sheath control guide wire 420 such as a development ring , and the imaging element 440 can be distributed on the branch sheath control guide wire 420 in the form of multiple arrays, so as to facilitate the determination of the position of the branch sheath 400 during the operation.
  • the delivery device further includes a guide head 500 disposed at the distal end of the inner catheter 300, the guide head 500 has an axially through lumen, and the lumen of the guide head 500 communicates with The lumen of the inner catheter 300, at this time, the main guide wire can pass through the inner lumen of the guide head 500 and the inner lumen of the inner catheter 300, and protrude from the distal end of the guide head 500, The distal end of the bifurcated stent 001 is connected to the guide head 500, and the delivery device can be sent into the diseased blood vessel through the main guide wire, and at the same time, the problem of precise release of the bifurcated stent 001 can be solved, wherein the guide head 500 has a tapered structure , can guide the delivery device to advance smoothly in the blood vessel.
  • the delivery device further includes a handle 600 with an axially through lumen, the distal end of the handle 600 is connected to the proximal end of the outer sheath 100, and the inner lumen of the handle 600 Connected with the inner cavity of the outer sheath tube 100, the handle 600 can assist the operator to hold the entire delivery device stably.
  • the handle 600 can also be used to control the delivery device.
  • Various links such as the release of the fork-shaped support 001 and the retraction of the delivery system are not limited here.
  • a stent system comprising the delivery device and a bifurcated stent 001 configured to fit on the inner catheter 300 . Since the structure, functional principles, and technical effects of the delivery device are all described in detail above, they will not be repeated here, and any technical content related to the delivery device can refer to the previous records.

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Abstract

L'invention concerne un appareil de pose et un système d'endoprothèse. L'appareil de pose comprend un tube de gaine externe (100), un tube à cavités multiples (200), un cathéter interne (300) et un tube de gaine ramifié (400). Le tube à cavités multiples (200) comprend une section corps principal (210) et une section à diamètre variable (220) située à l'extrémité distale de la section corps principal (210). Le diamètre de la section à diamètre variable (220) est inférieur au diamètre de la section corps principal (210), un espace de réception (231) est formé entre la paroi externe de la section à diamètre variable (220) et la paroi interne du tube de gaine externe (100), l'extrémité distale du cathéter interne (300) s'étend hors de l'extrémité distale du tube à cavités multiples (200), et le tube à cavités multiples (200) et le cathéter interne (300) sont agencés dans une cavité interne du tube de gaine externe (100).
PCT/CN2023/070824 2022-03-04 2023-01-06 Appareil de pose et système d'endoprothèse WO2023165261A1 (fr)

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CN114305570B (zh) * 2022-03-04 2022-05-20 上海微创心脉医疗科技(集团)股份有限公司 输送装置以及支架系统

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