WO2023020410A1 - 一种医用装置 - Google Patents

一种医用装置 Download PDF

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Publication number
WO2023020410A1
WO2023020410A1 PCT/CN2022/112357 CN2022112357W WO2023020410A1 WO 2023020410 A1 WO2023020410 A1 WO 2023020410A1 CN 2022112357 W CN2022112357 W CN 2022112357W WO 2023020410 A1 WO2023020410 A1 WO 2023020410A1
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WIPO (PCT)
Prior art keywords
stent
catheter
graft
medical device
distal end
Prior art date
Application number
PCT/CN2022/112357
Other languages
English (en)
French (fr)
Inventor
吴伟一
朱永锋
赵明杰
张博纬
朱清
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Application filed by 上海微创心脉医疗科技(集团)股份有限公司 filed Critical 上海微创心脉医疗科技(集团)股份有限公司
Priority to EP22857722.7A priority Critical patent/EP4344675A4/en
Priority to JP2024500155A priority patent/JP2024528802A/ja
Priority to US18/575,665 priority patent/US20240315827A1/en
Publication of WO2023020410A1 publication Critical patent/WO2023020410A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/061Blood vessels provided with means for allowing access to secondary lumens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097Visible markings, e.g. indicia

Definitions

  • the invention relates to the technical field of medical devices, in particular to a medical device.
  • a guide wire plus a catheter is generally used to introduce branch vessels, for example, from a lower extremity artery such as the femoral artery, and introduce branch arteries upward from the aorta, or, Access from the upper extremity arteries and carotid arteries, and from branch vessels down into the aorta.
  • the specific operation is generally to implant a main body covered stent with a fenestration first, then select a catheter that adapts to the angle of the branch vessel, guide the catheter to the vicinity of the branch vessel, and use the angle of the distal end of the catheter to align the branch vessel , and then introduce the guide wire from the catheter into the branch blood vessel to complete the establishment of the branch blood vessel access, and then implant the branch stent into the corresponding branch blood vessel along the guide wire.
  • the fenestration of the main covered stent needs to be aligned with the branch vessel, otherwise the opening of the branch vessel will be covered by the main covered stent, which will increase the difficulty of introducing the catheter and guide wire into the branch vessel. Prolong the operation time.
  • the purpose of the present invention is to provide a medical device, which can be used for minimally invasive interventional therapy involving aortic arch lesions, which can effectively reduce the difficulty of introducing a guide wire into branch vessels, facilitate the establishment of branch vessel access, and shorten the operation time.
  • the present invention provides a medical device, comprising: a stent-graft, a catheter and a binding piece, wherein the stent-graft is provided with a window; the catheter is used to be partially arranged on the stent-graft Inside; the tie is used to apply a radial compressive force to the stent-graft, so that the stent-graft shrinks radially to a compressed state; and the medical device is configured to hold the stent-graft In the compressed state, the position of the window corresponds to the position of the distal end of the catheter; the distal end refers to the end of the medical device that first enters the patient's body during use.
  • the stent-graft is further configured to apply pressure to the catheter and keep the stent-graft and the catheter relatively still.
  • the distal end of the catheter passes through the window and out of the stent-graft.
  • the catheter includes a main body segment and a distal end segment, the distal end segment is angularly connected to the distal end of the main body segment; the main body segment is partially disposed on the graft Within the stent, the distal segment passes through the window and out of the stent-graft.
  • the axis of the body segment is parallel to the axis of the stent-graft.
  • the axis of the main body segment and the axis of the distal end segment form an obtuse angle, and the angle of the obtuse angle is 150°-180°.
  • the medical device further includes a positioning element, the proximal end of the positioning element is connected to the distal end of the catheter, and the distal end of the positioning element is bound to the outer surface of the stent-graft by the binding element. On the surface.
  • the positioning member and the catheter are formed separately and connected together; or, the positioning member and the catheter are integrally structured.
  • a developing element is provided on the outer surface of the distal end of the catheter.
  • the medical device further includes an inner liner, and the inner liner is used to pass through the catheter.
  • the medical device further includes a transporter, the transporter includes an inner tube, the stent-graft is sleeved on the inner tube, and the catheter is used to be arranged between the inner tube and the covered tube. between membrane supports.
  • the catheter is also connected to the inner tube.
  • the medical device of the present invention has the following advantages: the aforementioned medical device includes a stent-graft, a catheter and a binding piece; the stent-graft is provided with a window; the inside of the stent-graft; the binding member is used to apply a radial extrusion force to the stent-graft, so that the stent-graft shrinks to a compressed state in the radial direction; the medical device is configured to When the stent graft is in the compressed state, the position of the window corresponds to the position of the distal end of the catheter, and the distal end refers to the end of the medical device that enters the patient's body first during use.
  • the stent-graft applies pressure to the catheter, so that the stent-graft and the catheter remain relatively still.
  • the stent-graft and the catheter can be delivered synchronously into the aorta, and the user can guide a guidewire along the catheter into the aorta and through the stent-graft before releasing the stent-graft
  • the upper window leads to the branch blood vessel, which simplifies the operation of introducing the catheter and guide wire into the branch blood vessel, and avoids the difficulty of superselection caused by the release of the covered stent and the misalignment of the window with the branch blood vessel, which is conducive to the establishment of the branch blood vessel access and shortens the operation time .
  • Fig. 1 is a schematic structural diagram of a medical device provided according to Embodiment 1 of the present invention.
  • Fig. 2 is a schematic structural view of the catheter of the medical device provided according to the first embodiment of the present invention.
  • Fig. 3 is a schematic diagram of an application scenario of the medical device provided according to Embodiment 1 of the present invention.
  • Fig. 4 is a schematic diagram of an application scene of the medical device provided according to Embodiment 1 of the present invention, in which a guide wire is introduced into a branch blood vessel.
  • Fig. 5 is a schematic structural diagram of the medical device provided by the second embodiment of the present invention.
  • Fig. 6 is a schematic diagram of a partial structure of a medical device provided by the third embodiment of the present invention.
  • FIG. 7 is a schematic diagram of a partial structure of the medical device provided by Embodiment 3 of the present invention, and the viewing directions of FIG. 7 and FIG. 6 are different.
  • each embodiment of the content described below has one or more technical features respectively, but this does not mean that the inventor must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. Some or all of the technical features. In other words, on the premise that the implementation is possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or Selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless the content clearly states otherwise.
  • the term “or” is generally used in the sense including “and/or”, unless the content clearly indicates otherwise, and the terms “install”, “connect” and “connect” should be To understand it in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two elements or the interaction relationship between two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
  • proximal refers to the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of a doctor using the medical device, although “proximal”, “distal ” is not limiting, but “proximal” generally refers to the end of the medical device that is closest to the practitioner during normal operation, and “distal” generally refers to the end that enters the patient first.
  • the patients here can be human or other animals.
  • the core idea of the present invention is to provide a medical device, which includes a stent graft, a catheter, and a binding piece.
  • the stent-graft is provided with a window
  • the catheter is used to be partially arranged inside the stent-graft.
  • the binding member is used for applying radial extrusion force to the stent-graft, so as to contract the stent-graft radially to a compressed state.
  • the position of the window corresponds to the position of the distal end of the catheter when the medical device is in the compressed state.
  • the medical device may be used for treatment of a lesion involving the aortic arch
  • the catheter may be delivered to the aortic arch together with the stent-graft, and before the stent-graft is released, when the window on the stent-graft is located
  • the user introduces a guide wire to the aortic arch through the catheter, and then the guide wire can be introduced into the branch vessel, avoiding the occurrence of catheter and guide wire introduction into the branch vessel after the stent graft is released in the prior art.
  • the window of the stent-graft is misaligned with the branch vessel, resulting in at least partial occlusion of the branch vessel opening.
  • the stent-graft also applies pressure to the catheter, and keeps the stent-graft and the catheter relatively still, so as to avoid displacement between the stent-graft and the catheter and cause the catheter to The distal end of the staggers the window.
  • FIG. 1 is a schematic structural diagram of a medical device provided by Embodiment 1 of the present invention.
  • the medical device 100 includes a stent graft 110 , a catheter 120 and a tie 130 .
  • the stent graft 110 is provided with a window 111 .
  • the catheter 120 is partially disposed inside the stent-graft 110 .
  • the binding member 130 is used to apply a radial extrusion force to the stent-graft 110 to shrink the stent-graft 110 to a compressed state in the radial direction.
  • the medical device 100 is configured such that the position of the window 111 corresponds to the position of the distal end of the catheter 120 when the stent-graft 110 is in the compressed state.
  • the catheter 120 has an axially through lumen, and the distal end of the catheter 120 is the distal opening of the inner cavity. Therefore, the distal end of the catheter 120 here The position of the portion corresponds to the position of the window 111, which means that the distal end of the catheter 120 corresponds to the position of the window 111 in the axial and circumferential directions of the stent graft 110, so that The stent graft 110 does not cover the distal opening of the lumen of the catheter 120 .
  • the distal end of the catheter 120 refers to the end of the catheter 120 that first enters the patient's body.
  • the stent graft 110 can be a self-expanding stent, and the material of the catheter 120 can be a polymer material such as PA12 or Pebax7233.
  • the medical device 100 may be used in the treatment of lesions involving the aortic arch.
  • the stent-graft 110 is in a compressed state under the action of the binding member 130 and is mounted on a conveyor (not shown in the figure) together with the catheter 120, and the conveyor is used to transport the stent-graft 110
  • the stent graft 110 and the catheter 120 are delivered to the patient's aortic arch, and the window 111 is located near a branch vessel.
  • the distal end of the catheter 120 is arranged correspondingly to the window 111 , the user can pass a guide wire 200 through the catheter 120 before releasing the stent graft 110 .
  • the lumen is delivered to the aortic arch and emerges from the distal end of the catheter 120 to guide branch vessels.
  • the advantage of this is that the stent-graft 110 and the catheter 120 are delivered into the body at one time, avoiding secondary delivery, and also avoiding the misalignment of the stent-graft 110 and the branch blood vessel after the release of the catheter 120. It is difficult to introduce branch blood vessels, thereby avoiding the problem that the guide wire 200 is difficult to introduce branch blood vessels, which is beneficial to establish branch blood vessel access and shorten operation time.
  • the stent-graft 110 also applies pressure to the catheter 120, and keeps the stent-graft 110 and the catheter 120 relatively still, so as to avoid the stent-graft 110 and the catheter 120
  • the change in relative position causes the distal end of the catheter 120 to be misaligned from the window 111 .
  • the medical device 100 further includes the conveyer, and the conveyer includes an inner tube and an outer tube.
  • the stent graft 110 is sleeved on the inner tube, and the outer tube is sleeved outside the inner tube and is also used to cover the stent graft 110 .
  • a developing element 140 is provided on the outer surface of the distal end of the catheter 120 to facilitate the user to judge the position of the distal end of the catheter 120 and the window 111 .
  • the distal end of the catheter 120 passes through the window 111 and extends out of the stent graft 110 .
  • the catheter 120 may include a main body section 121 and a distal end section 122 , preferably, the distal end section 122 is connected to the distal end of the main body section 121 at an angle.
  • the body segment 121 is partially disposed in the stent-graft 110, the distal segment 122 passes through the window 111 and protrudes from the stent-graft 110, that is, the distal segment
  • the end of the catheter 122 away from the body section 121 is the distal end of the catheter 120 .
  • an obtuse angle ⁇ is formed between the axis of the main body section 121 and the axis of the distal end section 122, and the angle of the obtuse angle ⁇ is preferably 150°-180°, and the main body section
  • the axis of 121 may be parallel to the axis of the stent-graft 110 .
  • the method of using the medical device is introduced: first, the medical device 100 is assembled.
  • the specific process is as follows: first, the stent-graft 110 is set on the inner tube of the conveyor, and the catheter 120 is partially passed through the stent-graft 110 .
  • the proximal end of the main body section 121 of the catheter 120 is located outside the stent-graft 110 and extends to the proximal end of the transporter, and the distal end of the main body section 121 is located on the stent-graft 110.
  • the distal segment 122 of the catheter 120 extends out of the stent-graft 110 from the window 111 .
  • the stent-graft 110 is bound by the binding member 130.
  • the binding member 130 can be any binding coil in the prior art, as long as it can make the stent-graft 110 shrink radially. and be fixed on the inner tube. That is to say, the binding member 130 can exert a radial pressing force on the stent-graft 110 on the outside of the stent-graft 110 , so that the stent-graft 110 is compressed and fixed on the inner tube.
  • the stent-graft 110 can also apply pressure to the catheter 120 under the action of the binding member 130, and keep the stent-graft 110 and the catheter 120 under the action of the pressure. relatively static.
  • the catheter 120 can also be used to connect the catheter 120 to the inner tube, so as to fix the catheter 120 between the stent-graft 110 and the inner tube. between, and keep the catheter 120 and the stent-graft 110 relatively still. Finally, the outer tube is covered on the outside of the stent graft 110 .
  • the stent-graft 110 and the catheter 120 are delivered to the patient's aortic arch according to conventional methods, and the outer tube is withdrawn to expose the stent-graft 110 .
  • the position of the stent graft 110 is adjusted so that the window 111 is near a branch vessel, and the distal end of the catheter 120 is aligned with the branch vessel (as shown in FIG. 3 ).
  • a guide wire 200 is delivered into the patient's body along the lumen of the catheter 120 , and the guide wire 200 protrudes from the distal end of the lumen and is directly introduced into a branch vessel (as shown in FIG. 4 ).
  • the restraint of the binding member 130 on the stent-graft 110 is released, and the stent-graft 110 is released. So far, the access of the branch blood vessel is established, and the user can continue to introduce the branch stent into the branch blood vessel.
  • Fig. 5 is a schematic structural diagram of the medical device provided by the second embodiment of the present invention, please refer to Fig. 5, the difference between this embodiment and the first embodiment is that the medical device 100 also includes a positioning member 150, the positioning The proximal end of the positioning member 150 is connected to the distal end of the catheter 120 , and the distal end of the positioning member 150 is restrained on the outer surface of the stent-graft 110 by the binding member 130 . By doing so, it can ensure that the catheter 120 and the stent-graft 110 remain relatively stationary, and prevent the distal end of the catheter 120 from being displaced from the window 111 due to displacement during delivery.
  • the proximal end of the positioning member 150 should not be connected to the side of the catheter 120 away from the central axis of the stent-graft 110, so as to avoid interference with the guide wire 200 and facilitate the guide wire 200 into branch vessels.
  • the proximal end of the positioning member 150 is connected to a side of the catheter 120 close to the central axis of the stent-graft 110 .
  • the positioning member 150 can be formed separately from the catheter 120 and then connected, and the positioning member 150 can be a metal wire or a polymer wire.
  • FIG. 6 and 7 are partial structural schematic diagrams of the medical device provided by the third embodiment of the present invention.
  • the difference between this embodiment and the second embodiment lies in that the positioning member 150 and the catheter 120 are in an integrated structure.
  • the positioning member 150 and the catheter 120 are made of the same tube, and the tube includes a first part and a second part axially connected, and the part of the first part far away from the stent-graft 110 A part of the tube wall of the central axis is cut off, and the remaining part of the tube wall of the first part close to the central axis of the stent-graft 110 forms the positioning part 150, and the positioning part 150 can cover 1/4 of the tube material -1/2 of the circumference.
  • the second part constitutes the conduit 120 .
  • part of the tube wall of the second part is also cut off, so that the distal end surface of the catheter 120 forms an inclined surface 123, and the inclined surface 123 is connected with the positioning member 150 in a smooth transition, reducing
  • the stress at the joint between the catheter 120 and the positioning member 150 can also increase the opening of the distal end of the lumen of the catheter 120 to facilitate the adjustment of the direction of the guide wire 200 .
  • the medical device 100 also includes a liner (not shown in the figure), and the liner is used to pass through the catheter 120 in the inner cavity.
  • the inner liner is used in the process of assembling the medical device 100 and delivering the stent-graft 110 to the patient.
  • the inner liner is withdrawn to prevent the stent-graft 110 from The lumen of the catheter 120 is closed by the stent-graft 110 and prevents the catheter 120 from being bent and deformed when the catheter 120 is twisted in the stent-graft 110 .
  • the material of the lining can be polymer such as Pebax7233, PTFE, PA12, etc., and its outer diameter is less than or equal to the inner diameter of the catheter 120.

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

Abstract

一种医用装置(100),包括:覆膜支架(110),覆膜支架(110)上设有窗口(111);导管(120),用于部分地设置在覆膜支架(110)内部;以及,束缚件(130),用于向覆膜支架(110)施加径向挤压力,以使覆膜支架(110)沿径向收缩至压缩态;医用装置(100)被配置为当覆膜支架(110)处于压缩态时,窗口(111)的位置与导管(120)的远端端部的位置相对应;远端是指医用装置(100)在使用过程中首先进入患者体内的一端。医用装置(100)可用于涉及主动脉弓的血管病变的治疗,有利于建立分支血管通路,缩短手术时间。

Description

一种医用装置 技术领域
本发明涉及医疗器械技术领域,具体涉及一种医用装置。
背景技术
涉及主动脉弓的动脉血管病变是非常复杂与危险的,医生往往会在开胸手术与微创伤介入手术之间做出选择。微创伤介入手术相比开胸手术具有创伤小、术后恢复快的优势,但其也存在一些问题,尤其是分支血管的处理,一直是各类产品的设计重点。
医生在执行微创伤介入手术时,大多采用DIY直管覆膜支架或一体化带有分支支架的主动脉覆膜支架系统,然而不论采用哪种支架系统,分支血管的通路建立都至关重要。现有技术中,在建立分支血管的通路时,一般采用导丝加导管的方式进行导入分支血管的操作,例如从下肢动脉如股动脉入路,并从主动脉往上导入分支动脉,或者,从上肢动脉和颈动脉入路,并从分支血管往下导入主动脉。具体操作一般是先植入一个带有开窗的主体覆膜支架,然后选择适应分支血管角度的导管,将此导管导引至分支血管附近,并利用导管远端塑形的角度对准分支血管,再从导管中将导丝导入分支血管以完成分支血管通路的建立,之后沿导丝将分支支架植入相应的分支血管。
针对这种建立分支血管通路的方法,主体覆膜支架的开窗需要与分支血管对准,否则分支血管的开口部分被主体覆膜支架覆盖,导致导管和导丝导入分支血管的难度增大,延长手术时间。
发明内容
本发明的目的在于提供一种医用装置,其可以用于涉及主动脉弓病变的微创伤介入治疗,可有效降低导丝导入分支血管的难度,有利于分支血管通路的建立,并缩短手术时间。
为实现上述目的,本发明提供了一种医用装置,包括:覆膜支架、导管和束缚件,其中所述覆膜支架上设有窗口;所述导管用于部分地设置在所述覆膜支架内部;所述束缚件用于向所述覆膜支架施加径向挤压力,以使所述覆膜支架沿径向收缩至压缩态;且所述医用装置被配置为当所述覆膜支架处于所述压缩态时,所述窗口的位置与所述导管的远端端部的位置相对应;所述远端是指所述医用装置在使用过程中首先进入患者体内的一端。
可选地,所述覆膜支架还被配置为向所述导管施加压力,并使所述覆膜支架与所述导管保持相对静止。
可选地,所述导管的远端端部穿过所述窗口并伸出所述覆膜支架。
可选地,所述导管包括主体节段和远端节段,所述远端节段成角度地连接于所述主体节段的远端;所述主体节段部分地设置于所述覆膜支架内,所述远端节段穿过所述窗口并伸出所述覆膜支架。
可选地,所述主体节段的轴线与所述覆膜支架的轴线平行。
可选地,所述主体节段的轴线与所述远端节段的轴线形成一钝角,所述钝角的角度为150°~180°。
可选地,所述医用装置还包括定位件,所述定位件的近端与所述导管的远端连接,所述定位件的远端被所述束缚件束缚于所述覆膜支架的外表面上。
可选地,所述定位件与所述导管分体成型,并连接于一体;或者,所述定位件与所述导管为一体式结构。
可选地,所述导管的远端外表面上设有显影元件。
可选地,所述医用装置还包括内衬,所述内衬用于穿设在所述导管内。
可选地,所述医用装置还包括输送器,所述输送器包括内管,所述覆膜支架套装在所述内管上,且所述导管用于设置在所述内管与所述覆膜支架之间。
可选地,所述导管还与所述内管连接。
与现有技术相比,本发明的医用装置具有如下优点:前述的医用装置包括覆膜支架、导管和束缚件;所述覆膜支架上设有窗口;所述导管用于部分地设置在所述覆膜支架内部;所述束缚件用于向所述覆膜支架施加径向挤压力,以使所述覆膜支架沿径向收缩至压缩态;所述医用装置被配置为当所述覆膜支架处于所述压缩态时,所述窗口的位置与所述导管的远端端部的位置相对应,所述远端是指所述医用装置在使用过程中首先进入患者体内的一端。并进一步优选所述覆膜支架向所述导管施加压力,以使所述覆膜支架与所述导管保持相对静止。如此,所述覆膜支架和所述导管可同步地输送至主动脉内,且使用者可在释放所述覆膜支架之前沿所述导管将导丝导入主动脉并穿过所述覆膜支架上的窗口导入分支血管,简化导管和导丝导入分支血管的操作,也避免因覆膜支架释放且窗口未对准分支血管导致的超选困难,有利于分支血管通路的建立,并缩短手术时间。
附图说明
附图用于更好地理解本发明,不构成对本发明的不当限定。
图1是本发明根据实施例一所提供的医用装置的结构示意图。
图2是本发明根据实施例一所提供的医用装置的导管的结构示意图。
图3是本发明根据实施例一所提供的医用装置的应用场景示意图。
图4是本发明根据实施例一所提供的医用装置的应用场景示意图,图示中导丝导入分支血管。
图5是本发明根据实施例二所提供的医用装置的结构示意图。
图6是本发明根据实施例三所提供的医用装置的局部结构示意图。
图7是本发明根据实施例三所提供的医用装置的局部结构示意图,图7与图6的观察方位不同。
附图标记说明如下:100-医用装置,110-覆膜支架,111-窗口,120-导管,121-主体节段,122-远端节段,123-斜面,130-束缚件,140-显影元件,150-定位件;200-导丝。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。需要说明的是,本实施例中所提供的图示仅以示意方式说明本发明的基本构想,遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制,其实际实施时各组件的型态、数量及比例可为一种随意的改变,且其组件布局型态也可能更为复杂。
另外,以下说明内容的各个实施例分别具有一或多个技术特征,然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征,或仅能分开实施不同实施例中的一部或全部技术特征。换句话说,在实施为可能的前提下,本领域技术人员可依据本发明的公开内容,并视设计规范或实作需求,选择性地实施任一实施例中部分或全部的技术特征,或者选择性地实施多个实施例中部分或全部的技术特征的组合,借此增加本发明实施时的 弹性。
如在本说明书中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,复数形式“多个”包括两个以上的对象,除非内容另外明确指出外。如在本说明书中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外,以及术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接。可以是机械连接,也可以是电连接。可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。
在本文中,术语“近端”、“远端”是从使用该医疗器械的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向,尽管“近端”、“远端”并非是限制性的,但是“近端”通常指该医疗设备在正常操作过程中靠近医生的一端,而“远端”通常是指首先进入患者体内的一端。这里的患者可以是人,也可以是其他动物。
本发明的核心思想在于提供一种医用装置,所述医用装置包括覆膜支架、导管、以及束缚件。其中,所述覆膜支架上设有窗口,所述导管用于部分地设置于所述覆膜支架内部。所述束缚件用于向所述覆膜支架施加径向挤压力,以使所述覆膜支架沿径向收缩至压缩态。当所述医用装置处于所述压缩态时,所述窗口的位置与所述导管的远端端部的位置相对应。所述医用装置可用于涉及主动脉弓处的病变的治疗,所述导管可随所述覆膜支架一起输送至主动脉弓处,且在释放所述覆膜支架之前,当所述覆膜支架上的窗口位于一分支血管附近时,使用者通过所述导管向主动脉弓导入导丝,进而所述导丝可导入分支血管,避免现有技术中释放所述覆膜支架之后执行导管和导丝导入分支血管时发生覆膜支架的窗口与分支血管未对准,导致分支血管开口至少部分被遮挡的问题。优选地,所述覆膜支架还向所述导管施加压力,并使所述覆膜支架与所述导管保持相对静止,避免所述覆膜支架与所述导管之间发生移位造成所述导管的远端端部错开所述窗口。
为使本发明的目的、优点和特征更加清楚,以下结合附图对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且均使用非精准的比例,仅用以方便、明晰地辅助说明本发明实施例的目的。附图中相同或相似的附图标记代表相同或相似的部件。
图1是本发明实施例一所提供的医用装置的结构示意图。请参考图1,所述医用装置100包括覆膜支架110、导管120和束缚件130。其中,所述覆膜支架110上设有窗口111。 所述导管120用于部分地设置在所述覆膜支架110的内部。所述束缚件130用于向所述覆膜支架110施加径向挤压力,以使所述覆膜支架110沿径向收缩至压缩态。所述医用装置100被配置为当所述覆膜支架110处于所述压缩态时,所述窗口111的位置与所述导管120的远端端部的位置相对应。本领域技术人员应知晓,所述导管120具有轴向贯通的内腔,所述导管120的远端端部即为所述内腔的远端开口,因此,这里所述导管120的远端端部的位置与所述窗口111的位置相对应,是指所述导管120的远端端部在所述覆膜支架110的轴向及周向上均与所述窗口111的位置相对应,以使所述覆膜支架110不覆盖所述导管120的内腔的远端开口。所述导管120的远端即是指所述导管120的首先进入患者体内的一端。所述覆膜支架110可以为自膨式支架,所述导管120的材质可以为高分子材料例如PA12或Pebax7233等。
所述医用装置100可用于涉及主动脉弓病变的治疗。实际工作时,所述覆膜支架110在所述束缚件130的作用下处于压缩状态并连同所述导管120一起安装于一输送器(图中未示出)上,所述输送器用于将所述覆膜支架110及所述导管120一并输送至患者的主动脉弓处,并使所述窗口111位于一分支血管附近。如图3及图4所示,由于所述导管120的远端与所述窗口111对应设置,因此在释放所述覆膜支架110之前,使用者可将一导丝200通过所述导管120的内腔输送至主动脉弓并从所述导管120的远端伸出,进而导入分支血管。这样做的优点在于,所述覆膜支架110及所述导管120一次性地输送至体内,避免二次输送,且还避免出现所述覆膜支架110释放后与分支血管未对准导致导管120导入分支血管困难,进而避免导丝200导入分支血管困难的问题,有利建立分支血管通路并缩短手术时间。较佳地,所述覆膜支架110还向所述导管120施加压力,并使所述覆膜支架110与所述导管120保持相对静止,以避免所述覆膜支架110与所述导管120的相对位置发生改变进而造成所述导管120的远端端部与所述窗口111错开。
可选地,所述医用装置100还包括所述输送器,所述输送器包括内管和外管。所述覆膜支架110套装在所述内管上,所述外管套装在所述内管外部并还用于覆盖所述覆膜支架110。
优选地,请返回参考图1并结合图2,所述导管120的远端外表面上设有显影元件140,方便使用者判断所述导管120的远端以及所述窗口111的位置。
优选地,请继续参考图1及图2,所述导管120的远端端部穿过所述窗口111并伸出 所述覆膜支架110。具体地,所述导管120可包括主体节段121和远端节段122,较佳地,所述远端节段122成角度地连接有所述主体节段121的远端。所述主体节段121部分地设置在所述覆膜支架110中,所述远端节段122穿过所述窗口111并伸出所述覆膜支架110,也即,所述远端节段122的远离所述主体节段121的一端部即为所述导管120的远端端部。这样做,更方便所述导丝200导入分支血管。本实施例中,所述主体节段121的轴线与所述远端节段122的轴线之间形成一钝角θ,所述钝角θ的角度优选为150°~180°,且所述主体节段121的轴线可与所述覆膜支架110的轴线平行。
接下去介绍所述医用装置的使用方法:首先组装所述医用装置100。具体过程为:先将所述覆膜支架110套装在所述输送器的内管上,并将所述导管120部分地穿设在所述覆膜支架110中。具体地,所述导管120的所述主体节段121的近端位于所述覆膜支架110的外部并延伸至所述输送器的近端,所述主体节段121的远端位于所述覆膜支架110与所述内管之间,而所述导管120的所述远端节段122从所述窗口111处伸出所述覆膜支架110。再利用所述束缚件130束缚所述覆膜支架110,本实施例中,所述束缚件130可以是现有技术中任意一种绑扎线圈,只要其能够使所述覆膜支架110径向收缩并固定在所述内管上即可。也即,所述束缚件130可以在所述覆膜支架110的外部向所述覆膜支架110施加径向挤压力,以使所述覆膜支架110压缩并固定在所述内管上。可选地,所述覆膜支架110在所述束缚件130的作用下还能够向所述导管120施加压力,并使所述覆膜支架110与所述导管120在所述压力的作用下保持相对静止。替代性地,在实践中,也可以利用其他方式例如绑扎或胶粘以使所述导管120与所述内管连接,以将所述导管120固定在所述覆膜支架110与所述内管之间,并使所述导管120与所述覆膜支架110保持相对静止。最后,将所述外管覆盖在所述覆膜支架110的外部。
接着,按照常规方法将所述覆膜支架110连同所述导管120输送至患者的主动脉弓处,并回撤所述外管,以使所述覆膜支架110露出。
接着,调整所述覆膜支架110的位置,以使所述窗口111处于一分支血管附近,并使所述导管120的远端对准分支血管(如图3所示)。
接着,将一导丝200沿所述导管120的内腔输送至患者体内,所述导丝200从所述内腔的远端伸出并直接导入分支血管(如图4所示)。
随后,解除所述束缚件130对所述覆膜支架110的束缚,释放所述覆膜支架110。至 此,分支血管的通路建立完成,使用者可继续向分支血管导入分支支架。
图5是本发明实施例二所提供的医用装置的结构示意图,请参考图5,本实施例与实施例一的区别之处在于,所述医用装置100还包括定位件150,所述定位件150的近端与所述导管120的远端连接,所述定位件150的远端被所述束缚件130束缚于所述覆膜支架110的外表面上。这样做,可确保所述导管120与所述覆膜支架110保持相对静止,避免所述导管120在输送过程中移位导致其远端端部偏离所述窗口111。可以理解的是,所述定位件150的近端不宜连接于所述导管120远离所述覆膜支架110的中心轴线的一侧,避免对所述导丝200造成干扰,有利于所述导丝200导入分支血管。优选地,所述定位件150的近端连接于所述导管120靠近所述覆膜支架110的中心轴线的一侧。
本实施例中,所述定位件150可以与所述导管120分体成型后再连接,所述定位件150可以是金属丝或高分子丝。
图6及图7是本发明实施例三所提供的医用装置的局部结构示意图。如图6及图7所示,本实施例与实施例二的区别之处在于,所述定位件150与所述导管120为一体式结构。具体来说,所述定位件150和所述导管120由同一根管材制作而成,所述管材包括轴向连接的第一部分和第二部分,所述第一部分的远离所述覆膜支架110的中心轴线的部分管壁被切除,所述第一部分剩余的靠近所述覆膜支架110的中心轴线的部分管壁形成所述定位件150,所述定位件150可覆盖所述管材的1/4-1/2的圆周面。所述第二部分构成所述导管120。
进一步地,所述第二部分的部分管壁也被切除,以使所述导管120的远端端面形成一斜面123,并使所述斜面123与所述定位件150平滑过渡地连接,减小所述导管120与所述定位件150连接处的应力,还可增大所述导管120的内腔的远端开口,方便调整所述导丝200的方向。
本发明实施例四所提供的医用装置与实施例一的区别之处在于,所述医用装置100还包括内衬(图中未示出),所述内衬用于穿设在所述导管120的内腔中。该内衬在组装所述医用装置100以及将所述覆膜支架110输送至患者体内的过程中使用,当所述覆膜支架110定位完成之后,该内衬撤出,其作用是避免所述导管120的所述内腔被所述覆膜支架110压闭,以及防止所述导管120在所述覆膜支架110内扭转时造成的打折变形。
所述内衬的材料可以为高分子例如Pebax7233、PTFE、PA12等,其外径小于或等于 所述导管120的内径。
虽然本发明披露如上,但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。

Claims (12)

  1. 一种医用装置,其特征在于,包括:
    覆膜支架,所述覆膜支架上设有窗口;
    导管,用于部分地设置在所述覆膜支架内部;以及,
    束缚件,用于向所述覆膜支架施加径向挤压力,以使所述覆膜支架沿径向收缩至压缩态;
    所述医用装置被配置为当所述覆膜支架处于所述压缩态时,所述窗口的位置与所述导管的远端端部的位置相对应;所述远端是指所医用装置在使用过程中首先进入患者体内的一端。
  2. 根据权利要求1所述的医用装置,其特征在于,所述覆膜支架还被配置为向所述导管施加压力,并使所述覆膜支架与所述导管保持相对静止。
  3. 根据权利要求1所述的医用装置,其特征在于,所述导管的远端端部穿过所述窗口并伸出所述覆膜支架。
  4. 根据权利要求3所述的医用装置,其特征在于,所述导管包括主体节段和远端节段,所述远端节段成角度地连接于所述主体节段的远端;所述主体节段部分地设置于所述覆膜支架内,所述远端节段穿过所述窗口并伸出所述覆膜支架。
  5. 根据权利要求4所述的医用装置,其特征在于,所述主体节段的轴线与所述覆膜支架的轴线平行。
  6. 根据权利要求4所述的医用装置,其特征在于,所述主体节段的轴线与所述远端节段的轴线形成一钝角,所述钝角的角度为150°~180°。
  7. 根据权利要求1-6中任一项所述的医用装置,其特征在于,所述医用装置还包括定位件,所述定位件的近端与所述导管的远端连接,所述定位件的远端被所述束缚件束缚于所述覆膜支架的外表面上。
  8. 根据权利要求7所述的医用装置,其特征在于,所述定位件与所述导管分体成型,并连接于一体;或者,所述定位件与所述导管为一体式结构。
  9. 根据权利要求1-6中任一项所述的医用装置,其特征在于,所述导管的远端外表面上设有显影元件。
  10. 根据权利要求1-6中任一项所述的医用装置,其特征在于,所述医用装置还包括内衬,所述内衬用于穿设在所述导管内。
  11. 根据权利要求1-6中任一项所述的医用装置,其特征在于,所述医用装置还包括输送器,所述输送器包括内管,所述覆膜支架套装在所述内管上,且所述导管用于设置在所述内管与所述覆膜支架之间。
  12. 根据权利要求11所述的医用装置,其特征在于,所述导管还与所述内管连接。
PCT/CN2022/112357 2021-08-17 2022-08-15 一种医用装置 WO2023020410A1 (zh)

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