WO2022142800A1 - 覆膜支架系统 - Google Patents

覆膜支架系统 Download PDF

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Publication number
WO2022142800A1
WO2022142800A1 PCT/CN2021/130942 CN2021130942W WO2022142800A1 WO 2022142800 A1 WO2022142800 A1 WO 2022142800A1 CN 2021130942 W CN2021130942 W CN 2021130942W WO 2022142800 A1 WO2022142800 A1 WO 2022142800A1
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WO
WIPO (PCT)
Prior art keywords
stent
graft
coil
restraint
window
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PCT/CN2021/130942
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English (en)
French (fr)
Inventor
王韶霞
舒畅
朱清
屠春霖
陈伊璐
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
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Publication of WO2022142800A1 publication Critical patent/WO2022142800A1/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
    • A61F2/962Instruments 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a stent-graft system.
  • Abdominal aortic aneurysm (AAA, Abdominal Aortic Aneurysm) is a common aortic disease in vascular surgery, which refers to the local pathological expansion of the abdominal aorta, exceeding 50% of the normal vascular diameter. Once the tumor ruptures, the fatality rate can be as high as 78% to 94%, which seriously endangers the life safety of patients. Due to the high difficulty and large surgical trauma of traditional surgical treatment, endovascular repair using abdominal aortic stent-graft has been widely used.
  • endovascular repair refers to the purpose of treating abdominal aortic aneurysm by delivering a stent-graft to the lesion site to establish a new blood flow channel in the tumor cavity, thereby isolating the impact of abdominal aortic hypertension blood flow on the tumor wall. a repair technique.
  • a stent-graft system is provided.
  • a stent-graft system comprising: a stent-graft and a beam diameter member arranged on the stent-graft;
  • the beam diameter member is used to restrain the stent-graft and can release the stent-graft;
  • the inner diameter of the stent-graft after restraint is smaller than the inner diameter after release, and the stent-graft after restraint has a through lumen.
  • the ratio of the restrained inner diameter to the released inner diameter of the stent-graft is (1-4):5.
  • the beam diameter member includes: a guide wire and a plurality of binding coils spaced along the length direction of the guide wire;
  • the restraint coil is used to restrain the stent-graft, and the restraint coil is detachably connected with the guide wire in a slip-knot manner, so that the stent-graft can be released when the guide wire is pulled.
  • the material of the restraint coil is selected from at least one of PET, PTFE, ePTFE, and PP.
  • the binding coil is connected to the guide wire in a slip-knot manner.
  • the first end of the confinement coil rotates around the stent-graft at least one turn and passes through the second end of the confinement coil;
  • the guide wire is passed through the first end of the restraint coil to fasten the restraint coil.
  • the plurality of binding coils are formed by bending the same binding wire.
  • the stent-graft is further provided with a plurality of fixed coils, and the confinement coils are circumferentially penetrated into the corresponding fixed coils.
  • the fixed coil includes at least one fixed coil group arranged along the axial direction of the stent-graft, each of the fixed coil groups is distributed around the circumference of the stent-graft and each The number of fixed coils in the fixed coil set is at least three.
  • the covered stent includes: a metal stent and a film covered on the metal stent;
  • the suture between the metal stent and the membrane is pulled out of the stent-graft to form the fixed coil.
  • the diameter bundle is braided by a restraining wire and is sheathed on the outside of the stent graft in an interference fit manner.
  • the metal bracket includes: a plurality of support rings arranged at intervals along the axial direction, the support rings are formed by connecting a plurality of support rods;
  • the fixed coil is located in a region where the ratio of the length L of the support rod is 1/3 to 2/3.
  • the stent-graft includes, from the proximal end to the distal end, a proximal-end stent-graft, an intermediate stent-graft and a distal-end stent-graft, wherein the inner diameter of the intermediate stent-graft is the smallest;
  • At least one first window is provided at the junction of the proximal stent-graft and the intermediate stent-graft, and at least one second window is provided at the junction of the intermediate stent-graft and the distal stent-graft, Both the first window and the second window are used for installing the branched stent-graft.
  • a first embedded branch is provided at the first window
  • a second embedded branch is provided at the second window
  • the first embedded branch is connected to the second embedded branch.
  • the branches are all located within the stent-graft.
  • the number of the first windows is two, the two first windows are circumferentially distributed on the same side of the stent-graft, and two adjacent first windows are The distance in the axial direction of the stent-graft is 0-30 mm.
  • the number of the second windows is two, the two second windows are circumferentially distributed on opposite sides of the stent-graft, and the two second windows are adjacent to each other
  • the distance in the axial direction of the stent-graft is 0-30 mm.
  • the proximal edge of the proximal stent-graft, and/or the distal edge of the distal stent-graft, and/or the first window, and/or the first window are provided with a developing part.
  • the developing portion is sutured and fixed by a suture.
  • the material of the developing part is at least one of tantalum, platinum-iridium alloy, and gold.
  • FIG. 1 is a schematic structural diagram of a stent-graft provided by an embodiment of the present invention after being bound by a diameter beam;
  • FIG. 2 is a schematic structural diagram of the proximal stent-graft of the stent-graft provided by an embodiment of the present invention after the stent-graft is released by the diameter bundle;
  • FIG. 3 is a schematic structural diagram of a stent graft provided by an embodiment of the present invention.
  • FIG. 4 is a schematic structural diagram of an abdominal aortic aneurysm involving the celiac trunk artery, the superior mesenteric artery, and the renal artery according to an embodiment of the present invention
  • FIG. 5 is a schematic structural diagram of a stent-graft provided with a first branch stent-graft and a second branch stent-graft according to an embodiment of the present invention
  • FIG. 6 is a schematic diagram of the positional relationship between the restraint coil provided by an embodiment of the present invention before it is wound around the stent graft;
  • FIG. 7 is a schematic structural diagram of a proximal stent-graft provided by an embodiment of the present invention after being bound by a diameter beam;
  • FIG. 8 is a schematic diagram of winding a restraint coil on a stent-graft provided by an embodiment of the present invention.
  • FIG. 9 is a schematic diagram of a process of bending a binding wire to form a plurality of binding coils according to an embodiment of the present invention.
  • FIG. 10 is a schematic diagram of the positional relationship between the restraint coil provided by another embodiment of the present invention before it is wound around the stent graft;
  • FIG. 11 is a schematic structural diagram of a stent-graft provided with a first branch stent-graft and a second branch stent-graft according to another embodiment of the present invention.
  • first and second are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature delimited with “first”, “second” may expressly or implicitly include at least one of that feature.
  • plurality means at least two, such as two, three, etc., unless otherwise expressly and specifically defined.
  • the terms “installed”, “connected”, “connected”, “fixed” and other terms should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection , or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between the two elements, unless otherwise specified limit.
  • installed may be a fixed connection or a detachable connection , or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between the two elements, unless otherwise specified limit.
  • a first feature "on” or “under” a second feature may be in direct contact between the first and second features, or the first and second features indirectly through an intermediary touch.
  • the first feature being “above”, “over” and “above” the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is level higher than the second feature.
  • the first feature being “below”, “below” and “below” the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.
  • an embodiment of the present invention provides a stent-graft system, including: a stent-graft 100 and a diameter beam member 200 disposed on the stent-graft 100; the diameter beam member 200 is used to restrain the stent-graft 100 and can release the stent-graft 100 (see FIG. 2 ); wherein, the inner diameter of the stent-graft 100 after restraint is smaller than the inner diameter after release, and the stent-graft 100 has a through lumen after restraint.
  • FIG. 2 is a schematic structural diagram of the proximal end of the stent-graft 100 after being released by the beam diameter member 200 . It should be noted that the proximal end in the text refers to the end close to the heart, and the distal end refers to the end away from the heart.
  • the stent-graft 100 includes: a metal stent 110 and a membrane 120 covering the metal stent 110; the membrane 120 has at least one window for installing the branch stent-graft.
  • the metal stent 110 is used to improve the adherence of the membrane 120
  • the metal stent 110 is made of a biocompatible metal material such as nickel-titanium alloy and stainless steel.
  • the metal bracket 110 includes a plurality of support rings 111 arranged at intervals along the axial direction; the support rings 111 can be arranged in a ring-shaped, wave-shaped structure, etc.
  • the material of the coating film 120 is a polymer material such as PET (Polyethylene terephthalate, polyester resin), ePTFE (Expanded Polytetrafluoroethylene, expanded polytetrafluoroethylene), etc.
  • PET Polyethylene terephthalate, polyester resin
  • ePTFE Expanded Polytetrafluoroethylene, expanded polytetrafluoroethylene
  • the coating film 120 of this type of material has a dense structure, uniform texture, and good anti-seepage. It has good blood performance, can fit blood vessels, has good flexibility, and can keep its shape unchanged under the impact of blood flow.
  • the proximal end of the stent-graft 100 is provided with a bare metal stent 130 to facilitate the anchoring of the proximal end.
  • FIG. 4 Taking the abdominal aortic aneurysm A involving the celiac trunk artery A1, the superior mesenteric artery A2, and the renal artery A3 shown in FIG. 4 as an example, the installation process of the above-mentioned stent graft system will be described below.
  • FIG. 4 Taking the abdominal aortic aneurysm A involving the celiac trunk artery A1, the superior mesenteric artery A2, and the renal artery A3 shown in FIG. 4 as an example, the installation process of the above-mentioned stent graft system will be described below.
  • the outgoing stent-graft 100 sequentially includes, from the proximal end to the distal end: the proximal-end stent-graft 100a, the intermediate stent-graft 100b and the distal-end stent-graft 100c, and between the proximal-end stent-graft 100a and the intermediate stent-graft 100b
  • There are two windows at the junction of the patient which are used to install the first branch stent-graft 300 leading to the involved celiac trunk artery A1 and superior mesenteric artery A2 respectively (see Figure 5 and Figure 11 )
  • the middle stent-graft There are two windows at the junction between 100b and the distal stent-graft 100c, and these two windows are used to install the second branch stent-graft 400 leading to the affected left and right renal arteries A3 respectively (see FIG. 5 and Figure 11):
  • the diameter bundle 200 is used to restrain the stent-graft 100 to reduce the inner diameter of the stent-graft 100; then, the stent-graft 100 is delivered to the lesion site of the abdominal aortic aneurysm A by using the delivery system.
  • the outer tube of the delivery system is first withdrawn until the stent-graft 100 is completely exposed, so as to release the stent-graft 100 to the diseased site, and then the first branch of the stent-graft 300 is transported by the delivery system.
  • the proximal end of the stent-graft 100a is inserted into the lumen of the stent-graft 100 and introduced into the celiac trunk artery A1 and the superior mesenteric artery A2.
  • the stent-graft 100 may be displaced, so that the first window deviates from the celiac trunk artery A1 and/or the superior mesenteric artery A2 in the circumferential direction.
  • the stent graft 130 can be released, and the stent graft 100 can be fine-tuned to achieve precise positioning.
  • the proximal stent graft 100a is released through the beam diameter member 200 to make the proximal stent graft 100a fit with the blood vessel.
  • the first branch stent-graft 300 is released.
  • the second branch stent-graft 400 is inserted into the lumen of the stent-graft 100 from the distal end of the distal-end stent-graft 100c using the delivery system, and introduced into the renal artery A3.
  • the stent-graft 100 may be displaced, so that the second window deviates from the renal artery A3 in the circumferential direction.
  • the stent-graft 100 can be fine-tuned to achieve precise positioning, and then the intermediate stent-graft 100b and the distal stent-graft 100c are released through the beam diameter member 200, so that the intermediate stent-graft 100b, the distal stent-graft 100c and the distal stent-graft 100c are released.
  • the blood vessel is attached, and then the second branch stent-graft 400 is released.
  • the bare metal stent 130 of the stent-graft 100 is released, the delivery system of the stent-graft 100 is withdrawn, and the release is completed.
  • the lumen bound by the stent graft 100 can always ensure the smooth passage of blood flow and ensure the lumen of the stent graft 100.
  • the blood perfusion can avoid the related complications caused by ischemia of the abdominal aorta and main lumen, and ensure the life safety of the patients.
  • the stent-graft system as described above can be used to treat complex abdominal aortic aneurysm A involving visceral arteries. Since the diameter bundle 200 can restrain the stent-graft 100, after the stent-graft system is introduced into the lesion site of abdominal aortic aneurysm A , the stent-graft 100 does not adhere to the blood vessel, and the stent-graft 100 can move between the proximal and distal ends after being restrained by the diameter beam 200 until the first window of the stent-graft 100 faces the celiac trunk artery A1 and/or the mesentery The artery A2 and the second window face the renal artery A3, and the stent-graft 100 can still be adjusted during the process of introducing the branched stent-graft to establish the channel, which is convenient for precise positioning, and the stent-graft 100 has a through lumen after restraint.
  • the perforated lumen enables smooth passage of blood flow, ensure
  • the ratio of the restrained inner diameter to the released inner diameter of the stent-graft 100 is (1-4):5, for example, the ratio can be 1:5, 2:5, 3 :5, 4:5, etc.
  • This arrangement can ensure that the lumen of the restrained stent-graft 100 can allow blood flow to pass through smoothly, and when the channel of the first branch stent-graft 300 and the second branch stent-graft 400 is established, if there is displacement, The stent graft 100 can still be moved up and down for adjustment.
  • the beam diameter member 200 includes: a guide wire 210 and a plurality of confinement coils 220 spaced along the length direction of the guide wire 210 ; the confinement coils 220 are used for constricting In the stent graft 100, the confinement coil 220 and the guide wire 210 are detachably connected, so that the stent graft 100 can be released when the guide wire 210 is pulled.
  • the diameter beam member 200 can also be braided by a tie wire and sheathed on the outside of the stent graft 100 in an interference fit.
  • the stent graft 100 When the stent graft 100 is released, it can be The diameter beam member 200 is removed by pulling one end of the restraint wire, and the removal principle is the same as that of removing the sweater, so that the purpose of releasing the stent graft 100 can be achieved.
  • the embodiment of the present invention is not specifically limited, as long as it has biocompatibility.
  • it can be PET (Polyethylene terephthalate, polyester resin), PTFE (Poly tetrafluoroethylene, polytetrafluoroethylene) ), ePTFE (Expanded Polytetrafluoroethylene, expanded polytetrafluoroethylene), PP (Polypropylene, polypropylene) and other polymer materials.
  • the material of the guide wire 210 there is no specific limitation in the embodiment of the present invention, as long as it has a certain hardness and certain flexibility, for example, it can be the same as the material of the metal stent 110, and can be Nitinol, stainless steel, etc. Capacitive metal material.
  • connection method between the binding coil 220 and the guide wire 210 either the method of bonding or the method of tying a slip knot can be used. Since the connection of the former is not firm, the embodiment of the present invention preferably adopts the latter.
  • the first end of the confinement coil 220 rotates around the stent-graft 100 at least one turn and passes through the second end of the confinement coil 220; the guide wire 210 is passed through the The first end of the tethered coil 220 is tied to tie the tethered coil 220 tightly.
  • the region A shown in FIG. 8 is used for threading the guide wire 210
  • the region B is used for wrapping the stent graft 100 .
  • the guide wire 210 When the guide wire 210 is pulled, the guide wire 210 is released from the first end of the restraint coil 220 , and the restraint coil 220 is released under the action of the restoring force of the stent graft 100 , thereby achieving the purpose of releasing the stent graft 100 .
  • the restraining coil 220 does not move with the guide wire 210 , but stays in the lesion of the abdominal aortic aneurysm A, and is in close contact with the wall of the blood vessel and the wall of the stent graft 100 .
  • the first end of the confinement coil 220 rotates around the stent graft 100 once, so that the confinement coil 220 can release the stent graft 100 after the guide wire 210 is pulled.
  • the cross section of the confinement coil 220 is flat, which can reduce the degree of damage caused to the stent graft 100 by the confinement coil 220 during the process of constricting and releasing the stent graft 100 .
  • a plurality of binding coils 220 are formed by bending the same binding wire M.
  • the second ends of the plurality of restraining coils 220 are located in the same direction, which facilitates the passing and pulling of the guide wire 210 .
  • the multiple confinement coils 220 may also be independent of each other.
  • the second end of the confinement coils 220 can also be used to thread the guide wire 210, that is, the second end of the confinement coils 220 can be used to pass through the guide wire 210.
  • One end and the second end are both sleeved on the outside of the guide wire 210 .
  • the above-mentioned binding wire M can be bent to form three binding coils 220 as an example, and the bending method of the binding wire M will be described:
  • the line segment between points, the line segment between points C and D, and the line segment between points E and F are bent outward to form the structure shown in Figure 9(b).
  • Points D, E and F are connected two by two to form the structure shown in FIG. 9( c ).
  • the way of connecting can be the way of gluing, sewing and knotting.
  • the line segment between point A and point B on the restraint line M can be bent outwards, and then point A and point B are connected to form a restraint coil 220 , and then follow this step to form the remaining two binding coils 220 .
  • the stent graft 100 is further provided with a plurality of fixed coils 170 , and the confinement coils 220 are penetrated in the corresponding fixed coils 170 in the circumferential direction .
  • the fixed coil 170 can limit the restraint coil 220, which can not only make the beam diameter member 200 effectively restrain the stent-graft 100, but also can move the restraint coil 220 along the fixed coil 170 during the process of drawing the guide wire 210 to effectively restrain the stent-graft 100.
  • the stent graft 100 is released.
  • the fixed coil 170 includes a plurality of fixed coil groups arranged along the axial direction of the stent graft 100 , each fixed coil group is distributed around the circumference of the stent graft 100 and each fixed coil group
  • the number of fixed coils is at least 3. In this way, the number of the fixed coils 170 can be reduced, and the beam diameter member 200 can be effectively bound to the stent graft 100 . It should be noted that when the confinement coil 220 is wound around the stent-graft 100 for multiple turns, each turn passes through the corresponding fixed coil group.
  • the stent graft 100 includes a metal stent 110 and a membrane 120 covering the metal stent 110; as shown in FIG. 7 , the suture between the metal stent 110 and the membrane 120 The stent-graft 100 is pulled out to form the fixed coil 170 .
  • the restraining coil 220 can restrain the metal stent 110 , and can restrain the stent graft 100 as a whole effectively.
  • the fixed coil 170 is a part of the suture between the metal stent 110 and the covering 120 , so the material of the fixing coil 170 is the same as the material of the suture between the metal stent 110 and the covering 120 .
  • the metal bracket 110 includes: a plurality of support rings 111 spaced along the axial direction, and the support rings 111 are connected by a plurality of support rods; the fixed coil 170 is located in the region where the ratio of the length L of the support rod is 1/3 to 2/3. In this way, the effective restraint of the beam diameter member 200 to different parts of the stent graft 100 can be ensured.
  • the length L of the support rod refers to the length of the support rod in the axial direction.
  • the stent-graft 100 sequentially includes from the proximal end to the distal end: a proximal-end stent-graft 100 a , an intermediate stent-graft 100 b and The distal stent-graft 100c and the intermediate stent-graft 100b have the smallest inner diameter; at least one first window is provided at the junction of the proximal-end stent-graft 100a and the intermediate stent-graft 100b, and the intermediate stent-graft 100b and the distal stent-graft are provided with at least one first window.
  • At least one second window is provided at the junction of 100c, and both the first window and the second window are used to install the branched stent-graft.
  • the inner diameter of the proximal stent-graft 100a and the distal stent-graft 100c is larger than that of the intermediate stent-graft 100b, which can reserve space for the branch stent-graft and improve the distal patency of the branch stent-graft.
  • the stent graft 100 provided with the first window and the second window can not only solve the problem of insufficient blood supply of visceral branches such as the celiac trunk artery A1 and the superior mesenteric artery A2, but also cover the branch artery lesions and prolong the proximal anchoring area. Solve the problem of too short proximal tumor diameter and insufficient anchoring.
  • the number of the first windows is two, the two first windows are circumferentially distributed on the same side of the stent graft 100, and the adjacent two first windows are on the same side of the stent graft 100.
  • the spacing in the axial direction of the stent 100 is 0 ⁇ 30 mm (for example, 0 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, etc.); and/or, as shown in FIG. 6 and FIG.
  • the number of the second windows is Two, two second windows are circumferentially distributed on opposite sides of the stent graft 100, and the distance between two adjacent second windows in the axial direction of the stent graft 100 is 0-30 mm (for example, 0 mm, 5 mm, 10mm, 15mm, 20mm, 25mm, 30mm, etc.).
  • the positional relationship between the two first windows can be the same as the positional relationship between the celiac trunk artery A1 and the superior mesenteric artery A2, and the positional relationship between the two second windows is the same as the positional relationship between the two renal arteries A3
  • the positional relationship is the same, which is convenient for the branched stent-graft to lead to the celiac trunk artery A1, the superior mesenteric artery A2 or the renal artery A3.
  • the number of the first window is at most two
  • the number of the second window The number is at most two.
  • a first embedded branch 140 is provided at the first window
  • a second embedded branch 150 is provided at the second window
  • the first embedded branch 150 is provided at the second window.
  • Both the embedded branch 140 and the second embedded branch 150 are located in the stent graft 100 .
  • the structures of the first embedded branch 140 and the second embedded branch 150 are the same as those of the stent graft 100 .
  • the branched stent-graft can be inserted into the first embedded branch 140 through the first window or inserted into the second embedded branch 150 through the second window, which can effectively prevent the occurrence of type III endoleak.
  • the proximal edge of the proximal stent-graft 100a, and/or the distal edge of the distal stent-graft 100c, and/or the first window, And/or the second window is provided with a developing part 160 .
  • the developing part 160 can precisely position the stent graft 100 .
  • the material of the developing part 160 is selected from at least one of tantalum, platinum-iridium alloy, and gold.
  • the developing portion 160 may be sutured and fixed by sutures.
  • the shape of the developing part 160 may be a ring shape, an "O" shape or an "8" shape.
  • the "8"-shaped developing part 160 can be regarded as being formed by splicing two "O"-shaped developing parts 160. Of course, in application, more than two "O"-shaped developing parts 160 can also be combined. spliced.
  • an annular developing portion 160 may be provided at the proximal edge of the proximal stent-graft 100a, the distal edge of the distal stent-graft 100c, the first window, and the second window, or at least one "O" "-shaped or "8"-shaped developing part 160.
  • This embodiment provides a stent-graft system for treating abdominal aortic aneurysm A involving celiac trunk artery A1 , superior mesenteric artery A2 and renal artery A3 (see FIG. 4 ). As shown in FIGS.
  • the stent-graft 100 includes a proximal-end stent-graft 100a, an intermediate stent-graft 100b and a distal-end stent-graft 100c connected in sequence, and the intermediate stent-graft 100b has the smallest inner diameter;
  • the two first windows at the junction of the stent 100a and the intermediate stent-graft 100b are respectively installed with first embedded branches 140 in the axial direction, and the two first windows at the junction of the intermediate stent-graft 100b and the distal stent-graft 100c
  • the two windows are respectively installed with second embedded branches 150, the two first windows are circumferentially distributed side by side on the same side of the stent graft 100, and the axial distance is zero, and the two second windows are circumferentially distributed side by side on the stent graft 100.
  • the opposite side of the stent 100, and the distance in the axial direction is zero.
  • the material of the membrane 120 of the stent-graft 100 is selected from polyester fabric (ie PET), polytetrafluoroethylene or other polymer materials, and the permeation amount meets the requirements of 0-500 mL/cm2/min;
  • the metal stent of the stent-graft 100 110 is made of nickel-titanium alloy wire or stainless steel, and includes a plurality of support rings arranged at intervals, the support rings are connected by a plurality of V-shaped units, and a bare metal stent 130 is provided at the proximal end of the stent graft 100, which is convenient for the proximal anchorage.
  • the restraint coil 220 in FIG. 6 is bound by the fixed coil 170 on the stent-graft 100 by means of the guide wire 210, that is, the restraint coil 220 is inserted into the corresponding fixed coil 170 in the circumferential direction, and the stent-graft 100 is bundled in diameter, that is, guided to the stent-graft 100.
  • the wire 210 penetrates the confinement coil 220 along the axial direction of the stent graft 100, and its bundle diameter ratio is 60% (ie, the ratio of the constricted inner diameter of the stent graft 100 to the released inner diameter is 3:5).
  • the fixed coil 170 is located in the middle of the proximal stent-graft 100a, the intermediate stent-graft 100b and the distal stent-graft 100c, and the proximal stent-graft 100a, the intermediate stent-graft 100b and the distal stent-graft 100c are all provided with There are 4 coils.
  • the stent graft 100 is firstly delivered to the lesion site of the abdominal aortic aneurysm A by using the delivery system.
  • the outer tube of the delivery system is first withdrawn until the stent graft 100 is completely exposed, so as to release the stent graft 100 to the lesion.
  • the first branch stent-graft 300 is introduced into the first embedded branch 140 from the proximal end of the proximal stent-graft 100a by using the delivery system. At this time, the stent-graft is released after the beam diameter state and the bare metal stent 130 is present.
  • the stent-graft 100 can be fine-tuned according to the actual situation, that is, if the positioning of the first branch stent-graft 300 is not accurate at this time, the stent-graft 100 can be fine-tuned between the proximal and distal ends until the positioning of the first branch stent-graft 300 is accurate, and then First, the guide wire 210 is pulled to release the proximal stent-graft 100a (as shown in FIG. 2 ), so that the proximal stent-graft 100a is attached to the blood vessel, and then the first branch stent-graft 300 is released.
  • the stent-graft 100 can be fine-tuned according to the actual situation, that is, if the positioning of the second branch stent-graft 400 is not accurate at this time, the stent-graft 100 can be fine-tuned between the proximal and distal ends until the second branch stent-graft 400 is positioned accurately, and then the guide wire 210 is first pulled to release the middle-end stent-graft 100b and the distal-end stent-graft 100c, so that the middle-end stent-graft 100b and the distal end-graft 100c are attached to the blood vessel, and then the first stent-graft is released. Two-branch stent-graft 400 . Finally, the bare metal stent 130 of the stent-graft 100 is released
  • This embodiment provides a stent-graft system for treating abdominal aortic aneurysm A involving celiac trunk artery A1 , superior mesenteric artery A2 and renal artery A3 (see FIG. 4 ).
  • the stent-graft 100 sequentially includes a proximal-end stent-graft 100a, an intermediate stent-graft 100b and a distal-end stent-graft 100c from the proximal end to the distal end, and the inner diameter of the intermediate stent-graft 100b is the smallest; as shown in FIG.
  • the two first windows at the junction of the proximal stent-graft 100a and the intermediate stent-graft 100b are respectively installed with first embedded branches 140 in the axial direction, the intermediate stent-graft 100b and the distal stent-graft 100c
  • the two second windows at the junction of the two second windows are respectively installed with second embedded branches 150.
  • the distance between the two first windows in the axial direction of the stent graft 100 is 8 mm and is circumferentially distributed on the same side of the stent graft 100.
  • the distance between the second windows in the axial direction of the stent-graft 100 is 6 mm and is circumferentially distributed on the opposite side of the stent-graft 100 .
  • the confinement coil 220 in FIG. 10 is bound by the fixed coil 170 on the stent-graft 100 with the help of the guide wire 210, that is, the confinement coil 220 is inserted into the corresponding fixed coil 170 in the circumferential direction, and the stent-graft 100 is bundled with the diameter of the guide wire.
  • 210 penetrates the restraint coil 220 along the axial direction of the stent graft 100, and its beam diameter ratio is 50% (ie, the ratio of the restrained inner diameter of the stent graft 100 to the released inner diameter is 1:2).
  • the stent graft 100 is firstly delivered to the lesion site of abdominal aortic aneurysm A by using the delivery system.
  • the outer tube of the delivery system is first withdrawn until the stent graft 100 is completely exposed, so as to place the stent graft 100 on the lesion.
  • the first branch stent-graft 300 is introduced from the carotid artery puncture through the proximal end of the proximal stent-graft 100a and introduced into the celiac trunk artery A1 and the superior mesenteric artery A2 through the first embedded branch 140.
  • the stent-graft 100 can be fine-tuned between the proximal and distal ends until the first branch stent-graft 300 positioning is accurate. Then, the guide wire 210 is pulled to release the proximal stent-graft 100a, so that the proximal stent-graft 100a is attached to the blood vessel, and then the first branch stent-graft 300 is released.
  • the stent graft 100 can be fine-tuned according to the actual situation, that is, if the positioning of the second branch stent-graft 400 is not accurate at this time, the stent-graft 100 can be fine-tuned between the proximal and distal ends until the second branch stent-graft 400 The positioning is accurate, and then the guide wire 210 is pulled to release the middle-end stent-graft 100b and the distal-end stent-graft 100c, so that the middle-end stent-graft 100b and the distal-end stent-graft 100c are attached to the blood vessel, and then the second stent-graft is released. Branched stent-graft 400. Finally, the bare metal stent 130 of the stent-graft 100

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Abstract

一种覆膜支架系统,包括覆膜支架(100)与设置在覆膜支架(100)上的束径件(200);束径件(200)用于束缚覆膜支架(100)且能够释放覆膜支架(100);覆膜支架(100)束缚后的内径小于释放后的内径,束缚后的覆膜支架(100)具有贯通的内腔。由于束径件(200)可束缚覆膜支架(100),待覆膜支架系统导入腹主动脉瘤(A)病变部位之后,覆膜支架(100)不与血管贴合,覆膜支架(100)经束径件(200)束缚之后可在近、远端之间移动直至覆膜支架(100)的第一窗口朝向腹腔干动脉(A1)和/或肠系膜上动脉(A2)及第二窗口朝向肾动脉(A3),在分支覆膜支架(300,400)导入以建立血流通道的过程中仍可调整覆膜支架(100),利于精准定位,束缚后的覆膜支架(100)具有贯通的内腔,贯通的内腔能够使血流顺畅通过,保障覆膜支架(100)内腔的血流灌注。

Description

覆膜支架系统 技术领域
本发明涉及医疗器具技术领域,特别是涉及一种覆膜支架系统。
背景技术
腹主动脉瘤(AAA,Abdominal Aortic Aneurysm)是血管外科常见的主动脉疾病,是指腹主动脉局部病理性扩张,超过正常血管管径的50%。一旦瘤体发生破裂,致死率可高达78%~94%,严重危及患者的生命安全。由于传统的外科治疗手术实施难度高、手术创伤大,利用腹主动脉覆膜支架实施的腔内修复术已被广泛应用。其中,腔内修复术是指通过将覆膜支架输送至病变部位以在瘤腔内建立新的血流通道,进而隔绝腹主动脉高压血流对瘤壁的冲击,达到治疗腹主动脉瘤目的的一种修复技术。
其中,对于累及内脏动脉的复杂腹主动脉瘤,例如肾动脉、肋间动脉,治疗难度大,需要在覆膜支架上开设窗口,在窗口再安装分支覆膜支架,通往累及的分支血管。然而,增加分支覆膜支架的植入,会增大手术操作难度,提高临床风险。
发明内容
根据本申请的各种实施例,提供一种覆膜支架系统。
一种覆膜支架系统,所述覆膜支架系统包括:覆膜支架与设置在所述覆膜支架上的束径件;
所述束径件用于束缚所述覆膜支架且能够释放所述覆膜支架;
其中,所述覆膜支架束缚后的内径小于释放后的内径,且束缚后所述覆膜支架具有贯通的内腔。
在其中的一个实施例中,所述覆膜支架束缚后的内径与释放后的内径的比值为(1~4):5。
在其中的一个实施例中,所述束径件包括:导向丝以及沿所述导向丝的长度方向间隔分布的多个束缚线圈;
所述束缚线圈用于束缚所述覆膜支架,所述束缚线圈以打活结的方式与所述导向丝可拆卸连接,以使当抽拉所述导向丝时能够释放所述覆膜支架。
在其中的一个实施例中,所述束缚线圈的材质选自PET、PTFE、ePTFE、PP中的至少一种。
在其中的一个实施例中,所述束缚线圈以打活结的方式与所述导向丝连接。
在其中的一个实施例中,所述束缚线圈的第一端围绕所述覆膜支架旋转至少一圈并从所述束缚线圈的第二端穿出;
所述导向丝穿设于所述束缚线圈的第一端,以将所述束缚线圈系紧。
在其中的一个实施例中,所述多个束缚线圈通过同一束缚线弯折而成。
在其中的一个实施例中,所述覆膜支架上还设置有多个固定线圈,所述束缚线圈周向穿设于对应的所述固定线圈中。
在其中的一个实施例中,所述固定线圈包括沿所述覆膜支架的轴向设置的至少一个固定线圈组,每个所述固定线圈组绕所述覆膜支架的周向分布且每个所述固定线圈组的固定线圈数目至少为3个。
在其中的一个实施例中,所述覆膜支架包括:金属支架与覆盖于所述金属支架上的覆膜;
所述金属支架与所述覆膜间的缝合线向所述覆膜支架的外部拉出,以形成所述固定线圈。
在其中的一个实施例中,所述束径件通过束缚线编织而成并以过盈配合的方式套于所述覆膜支架的外部。
在其中的一个实施例中,所述金属支架包括:沿轴向间隔设置的多个支撑环,所述支撑环由多个支撑杆连接而成;
所述固定线圈位于所述支撑杆长度L比例为1/3~2/3的区域。
在其中的一个实施例中,所述覆膜支架由近端至远端依次包括:近端覆膜支架、中间覆膜支架及远端覆膜支架,所述中间覆膜支架的内径最小;
所述近端覆膜支架与所述中间覆膜支架的交界处设置有至少一个第一窗口,所述中间覆膜支架与所述远端覆膜支架的交界处设置有至少一个第二窗口,所述第一窗口与所述第二窗口均用于安装分支覆膜支架。
在其中的一个实施例中,所述第一窗口处设置有第一内嵌分支,所述第二窗口处设置有第二内嵌分支,所述第一内嵌分支与所述第二内嵌分支均位于所述覆膜支架内。
在其中的一个实施例中,所述第一窗口的数目为两个,两个所述第一窗口周向分布在所述覆膜支架的同侧上,且相邻两个所述第一窗口在所述覆膜支架轴向上的间距为0~30mm。
在其中的一个实施例中,所述第二窗口的数目为两个,两个所述第二窗口周向分布在所述覆膜支架的对侧上,且相邻两个所述第二窗口在所述覆膜支架轴向上的间距为0~30mm。
在其中的一个实施例中,所述近端覆膜支架的近端边缘、和/或所述远端覆膜支架的远端边缘、和/或所述第一窗口、和/或所述第二窗口设置有显影部。
在其中的一个实施例中,所述显影部通过缝合线缝合固定。
在其中的一个实施例中,所述显影部的材质选取钽、铂铱合金、黄金中的至少一种。
本申请的一个或多个实施例的细节在下面的附图和描述中提出。本申请的其他特征、目的和优点将从说明书、附图以及权利要求书变得明显。
附图说明
为了更好地描述和说明这里公开的那些申请的实施例和/或示例,可以参考一幅或多幅附图。用于描述附图的附加细节或示例不应当被认为是对所公开的申请、目前描述的实施例和/或示例以及目前理解的那些申请的最佳模式中的任何一者的范围的限制。
图1为本发明一实施例提供的覆膜支架经束径件束缚后的结构示意图;
图2为本发明一实施例提供的覆膜支架的近端覆膜支架经束径件释放后的结构示意图;
图3为本发明一实施例提供的覆膜支架的结构示意图;
图4为本发明一实施例提供的累及腹腔干动脉、肠系膜上动脉和肾动脉的腹主动脉瘤的结构示意图;
图5为本发明一实施例提供的安装有第一分支覆膜支架、第二分支覆膜支架的覆膜支架的结构示意图;
图6为本发明一实施例提供的束缚线圈未缠绕于覆膜支架之前这两者之间的位置关系示意图;
图7本发明一实施例提供的近端覆膜支架经束径件束缚后的结构示意图;
图8本发明一实施例提供的束缚线圈在覆膜支架上的缠绕示意图;
图9为本发明一实施例提供的束缚线弯折形成多个束缚线圈的过程示意图;
图10为本发明另一实施例提供的束缚线圈未缠绕于覆膜支架之前这两者之间的位置关系示意图;
图11为本发明另一实施例提供的安装有第一分支覆膜支架、第二分支覆膜支架的覆膜支架的结构示意图。
其中,附图中的标号说明如下:
100、覆膜支架;110、金属支架;111、支撑环;120、覆膜;100a、近端覆膜支架;100b、中间覆膜支架;100c、远端覆膜支架;130、裸金属支架;140、第一内嵌分支;150、第二内嵌分支;160、显影部;170、固定线圈;200、束径件;210、导向丝;220、束缚线圈;300、第一分支覆膜支架;400、第二分支覆膜支架;A、腹主动脉瘤;A1、腹腔干动脉;A2、肠系膜上动脉;A3、肾动脉;M、束缚线。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施例的限制。
在本发明的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。
此外,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本发明的描述中,“多个”的含义是至少两个,例如两个,三个等,除非另有明确具体的限定。
在本发明中,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;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,除非另有明确的限定。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。
在本发明中,除非另有明确的规定和限定,第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触,或第一和第二特征通过中间媒介间接接触。而且,第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方,或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”可以是第一特征在第二特征正下方或斜下方,或仅仅表示第一特征水平高度小于第二特征。
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。
如图1所示,本发明一实施例提供了一种覆膜支架系统,包括:覆膜支架100与设置在覆膜支架100上的束径件200;束径件200用于束缚覆膜支架100且能够释放覆膜支架100(参见图2);其中,覆膜支架100束缚后的内径小于释放后的内径,且束缚后覆膜支架100具有贯通的内腔。图2是覆膜支架100的近端经束径件200释放后的结构示意图。需要说明的是,全文中的近端是指靠近心脏的一端,远端是指远离心脏的一端。
作为一种示例,如图1所示,覆膜支架100包括:金属支架110和覆盖于金属支架110上的覆膜120;覆膜120上具有至少一个窗口,用于安装分支覆膜支架。金属支架110用于提高覆膜120的贴壁性,金属支架110材质为镍钛合金、不锈钢等具有生物相容性的金属材质。其中,如图7所示,金属支架110包括沿轴向间隔设置的多个支撑环111;支撑环111可以设置成圆环型、波浪型等结构,可以理解的是,波浪型的支撑环111是由多个支撑杆连接而成。覆膜120的材质为PET(Polyethylene terephthalate,涤纶树脂)、ePTFE(Expanded Polytetrafluoroethylene,膨体聚四氟乙烯)等高分子材料,该类材质的覆膜120结构致密、质地均匀,具有良好的防渗血性能,能够贴合血管,柔顺性良好,在血流冲击下可保持形状不变。
作为一种示例,如图3所示,覆膜支架100的近端设置有裸金属支架130,利于近端锚定。
下面以图4所示出的累及腹腔干动脉A1、肠系膜上动脉A2、肾动脉A3的腹主动脉瘤A为例,就上述所述的覆膜支架系统的安装过程进行描述,其中图3示出的覆膜支架100由近端至远端依次包括:近端覆膜支架100a、中间覆膜支架100b及远端覆膜支架100c,且近端覆膜支架100a、中间覆膜支架100b之间的交界处具有两个窗口,这两个窗口分别用于安装通往累及的腹腔干动脉A1、肠系膜上动脉A2的第一分支覆膜支架300(参见图5及图11),中间覆膜支架100b与远端覆膜支架100c之间的交界处具有两个窗口,这两个窗口分别用于安装通往累及的左、右两肾动脉A3的第二分支覆膜支架400(参见图5及图11):
应用时,先利用束径件200束缚覆膜支架100,减小覆膜支架100的内径;之后利用输送系统将覆膜支架100输送至腹主动脉瘤A的病变部位。当覆膜支架100导入至病变部位时,先回撤输送系统的外管直至完全显露覆膜支架100,以将覆膜支架100释放至病变部位,之后利用输送系统将第一分支覆膜支架300从近端覆膜支架100a的近端穿入覆膜支架100的内腔,导入至腹腔干动脉A1、肠系膜上动脉A2。在第一分支覆膜支架300导入的过程中,覆膜支架100可能会移位,使得第一窗口周向上偏离腹腔干动脉A1和/或肠系膜上动脉A2朝向,此时因覆膜支架100处于束径状态且有裸金属支架130后释放,可微调覆膜支架100以实现精准定位,之后先通过束径件200释放近端覆膜支架100a,使近端覆膜支架100a与血管贴合,然后再释放第一分支覆膜支架300。同样地,利用输送系统将第二分支覆膜支架400从远端覆膜支架100c的远端穿入覆膜支架100的内腔,导入至肾动脉A3。在第二分支覆膜支架400导入的过程中,覆膜支架100可能会移位,使得第二窗口周向上偏离肾动脉A3朝向, 此时因覆膜支架100处于束径状态且有裸金属支架130后释放,可微调覆膜支架100以实现精准定位,之后先通过束径件200释放中间覆膜支架100b、远端覆膜支架100c,使中间覆膜支架100b、远端覆膜支架100c与血管贴合,然后再释放第二分支覆膜支架400。最后释放覆膜支架100的裸金属支架130,回撤覆膜支架100的输送系统,释放完成。需要说明的是,在导入第一分支覆膜支架300、第二分支覆膜支架400的过程中,覆膜支架100束缚后的内腔始终能够保证血流顺畅通过,保障覆膜支架100内腔的血流灌注,避免因腹主动脉主腔缺血而导致的相关并发症,保证患者的生命安全。
如上所述的覆膜支架系统,可用于治疗累及内脏动脉的复杂腹主动脉瘤A,由于束径件200可束缚覆膜支架100,那么待覆膜支架系统导入腹主动脉瘤A病变部位之后,覆膜支架100不与血管贴合,覆膜支架100经束径件200束缚之后可在近、远端之间移动直至覆膜支架100的第一窗口朝向腹腔干动脉A1和/或肠系膜上动脉A2及第二窗口朝向肾动脉A3,同时在分支覆膜支架导入以建立通道的过程中仍可调整覆膜支架100,利于精准定位,且束缚后覆膜支架100具有贯通的内腔,该贯通的内腔使血流顺畅通过,保障覆膜支架100内腔的血流灌注,避免因腹主动脉主腔缺血而导致的相关并发症。
在本发明的一些实施例中,覆膜支架100束缚后的内径与释放后的内径的比值为(1~4):5,举例来说,该比值可以为1:5、2:5、3:5、4:5等。如此设置,可保证束缚后的覆膜支架100的内腔能够使血流顺畅通过,也可在建立第一分支覆膜支架300和第二分支覆膜支架400的通道时,若有移位,仍可上下移动覆膜支架100进行调整。
在本发明的一些实施例中,如图1及图2所示,束径件200包括:导向丝210以及沿导向丝210的长度方向间隔分布的多个束缚线圈220;束缚线圈220用于束缚覆膜支架100,束缚线圈220与导向丝210可拆卸连接,以使当抽拉导向丝210时能够释放覆膜支架100。当然了,在本发明的其他一些实施例中,束径件200也可通过束缚线编织而成并以过盈配合的方式套于覆膜支架100的外部,在释放覆膜支架100时,可通过抽拉束缚线的一端来拆除束径件200,其拆除原理与拆毛衣的原理相同,进而可以达到释放覆膜支架100的目的。
关于束缚线圈220的材质,本发明实施例也不进行具体限制,只要具备生物相容性即可,示例地,可以为PET(Polyethylene terephthalate,涤纶树脂)、PTFE(Poly tetra fluoroethylene,聚四氟乙烯)、ePTFE(Expanded Polytetrafluoroethylene,膨体聚四氟乙烯)、PP(Polypropylene,聚丙烯)等高分子材料制成。
关于导向丝210的材质,本发明实施例不进行具体限制,只要具有一定的硬度和一定的柔性即可,例如,可与金属支架110的材质相同,可以为镍钛合金、不锈钢等具有生物相容性的金属材质。
关于束缚线圈220与导向丝210之间的连接方式,要么通过粘接的方式,要么可通过打活结的方式。基于前者连接不牢固,本发明实施例优先采用后者。
具体到本发明的一些实施例中,如图8所示,束缚线圈220的第一端围绕覆膜支架100旋转至少一圈并从束缚线圈220的第二端穿出;导向丝210穿设于束缚线圈220的第一端,以将束缚线圈220系紧。图8中所述示出的A区域用于使导向丝210穿设,B区域用于缠绕覆膜支架100。当抽拉导向丝210时,导向丝210从束缚线圈220的第一端中脱出,束缚线圈220便在覆膜支架100复位力的作用下松开,进而达到释放覆膜支架100的目的。需要说明的是,束缚线圈220并未随导向丝210一起运动,而是留在腹主动脉瘤A的病变部位内,贴紧于血管壁与覆膜支架100的壁之间。
可选地,束缚线圈220的第一端围绕覆膜支架100旋转一圈,便于束缚线圈220在导向丝210抽拉之后释放覆膜支架100。束缚线圈220的横截面为扁平状,可减小束缚线圈220在束缚、释放覆膜支架100过程中对其造成的损坏程度。
可选地,如图6及图9所示,多个束缚线圈220通过同一束缚线M弯折而成。如此,多个束缚线圈220的第二端位于同一方向上,便于导向丝210的穿设与抽拉。当然了,在本发明的其他一些实施例中,多个束缚线圈220也可以是相互独立的,此时束缚线圈220的第二 端也可用于使导向丝210穿设,即束缚线圈220的第一端、第二端均套于导向丝210的外部。
其中,就上述束缚线M可以弯折形成3个束缚线圈220为例,对束缚线M的弯折方式进行描述:先将图9(a)中的束缚线M上的A点与B点之间的线段、C点与D点之间的线段以及E点与F点之间的线段向外弯曲,形成图9(b)所示出的结构,之后将A点与B点、C点与D点和E点与F点两两相连成图9(c)所示出的结构。可选地,相连的方式可以为粘接、缝合以及打结的方式。当然了,在本发明的其他一些实施例中,可以先将束缚线M上的A点与B点之间的线段向外弯曲然后再将A点与B点相连接,以形成一个束缚线圈220,之后按照该步骤形成剩余两个束缚线圈220。
进一步地,如图6及图7所示,在本发明的一些实施例中,覆膜支架100上还设置有多个固定线圈170,束缚线圈220沿周向穿设于对应的固定线圈170中。固定线圈170可以对束缚线圈220起到限位作用,既能使束径件200有效束缚覆膜支架100,也可在抽拉导向丝210的过程中束缚线圈220沿着固定线圈170运动以有效将覆膜支架100进行释放。
可选地,如图7所示,固定线圈170包括沿覆膜支架100的轴向设置的多个固定线圈组,每个固定线圈组绕覆膜支架100的周向分布且每个固定线圈组的固定线圈数目至少为3个。如此,既可以减小固定线圈170的设置数目,也可保证束径件200对覆膜支架100有效束缚。需要说明的是,当束缚线圈220绕所述覆膜支架100缠绕多圈时,每一圈穿设于对应的固定线圈组中。
更进一步地,在本发明的一些实施例中,覆膜支架100包括金属支架110和覆盖于金属支架110上的覆膜120;如图7所示,金属支架110与覆膜120间的缝合线向覆膜支架100的外部拉出,以形成固定线圈170。如此,束缚线圈220可对金属支架110进行束缚,可有效对覆膜支架100整体进行束缚。可以理解的是,固定线圈170是金属支架110与覆膜120间的缝合线的一部分,故固定线圈170的材质和金属支架110与覆膜120间的缝合线的材质相同。
可选地,如图2、图3、图5及图7所示,金属支架110包括:沿轴向间隔设置的多个支撑环111,支撑环111由多个支撑杆连接而成;固定线圈170位于支撑杆长度L比例为1/3~2/3的区域。如此,可以保证束径件200对覆膜支架100不同部位的有效束缚。其中,支撑杆长度L是指支撑杆轴向上的长度。
如图2、图3、图5及图11所示,在本发明的一些实施例中,覆膜支架100由近端至远端依次包括:近端覆膜支架100a、中间覆膜支架100b及远端覆膜支架100c,中间覆膜支架100b的内径最小;近端覆膜支架100a与中间覆膜支架100b的交界处设置有至少一个第一窗口,中间覆膜支架100b与远端覆膜支架100c的交界处设置有至少一个第二窗口,第一窗口与第二窗口均用于安装分支覆膜支架。近端覆膜支架100a、远端覆膜支架100c的内径均大于中间覆膜支架100b,可以为分支覆膜支架预留空间,提高分支覆膜支架的远端通畅性。另外,设置有第一窗口、第二窗口的覆膜支架100不仅可以解决腹腔干动脉A1、肠系膜上动脉A2等内脏分支供血不足的问题,而且也覆盖分支动脉病变,延长近端锚定区,解决近端瘤径过短、锚定不足的问题。
可选地,如图6及图10所示,第一窗口的数目为两个,两个第一窗口周向分布在覆膜支架100的同侧,且相邻两个第一窗口在覆膜支架100轴向上的间距为0~30mm(示例地,0mm、5mm、10mm、15mm、20mm、25mm、30mm等);和/或,如图6及图10所示,第二窗口的数目为两个,两个第二窗口周向分布在覆膜支架100的对侧,且相邻两个第二窗口在覆膜支架100轴向上的间距为0~30mm(示例地,0mm、5mm、10mm、15mm、20mm、25mm、30mm等)。如此,可以使两个第一窗口之间的位置关系与腹腔干动脉A1和肠系膜上动脉A2之间的位置关系相同,两个第二窗口之间的位置关系与两个肾动脉A3之间的位置关系相同,便于分支覆膜支架通向腹腔干动脉A1、肠系膜上动脉A2或肾动脉A3。需要说明的是,腹腔干动脉A1、肠系膜上动脉A2、两个肾动脉A3上通入的分支覆膜支架均为1个,此时,第一窗口的数目至多为两个、第二窗口的数目至多为两个。
进一步地,在本发明的一些实施例中,如图3及图6所示,第一窗口处设置有第一内嵌分支140,第二窗口处设置有第二内嵌分支150,第一内嵌分支140与第二内嵌分支150均位于覆膜支架100内。需要说明的是,第一内嵌分支140、第二内嵌分支150的结构与覆膜支架100的结构相同。分支覆膜支架可穿过第一窗口插设于第一内嵌分支140中或穿过第二窗口插设于第二内嵌分支150中,可有效防止Ⅲ型内漏的发生。
进一步地,如图3所示,在本发明的一些实施例中,近端覆膜支架100a的近端边缘、和/或远端覆膜支架100c的远端边缘、和/或第一窗口、和/或第二窗口设置有显影部160。显影部160可以使覆膜支架100精确定位。
可选地,显影部160的材质选取钽、铂铱合金、黄金中的至少一种。
可选地,显影部160可通过缝合线缝合固定。其中,显影部160的形状可以为环形、“O”形或“8”形。其中,“8”形的显影部160可以看作是由两个“O”形的显影部160拼接而成,当然了,在应用时也可以将两个以上的“O”形的显影部160相拼接。另外,近端覆膜支架100a的近端边缘、远端覆膜支架100c的远端边缘、第一窗口、第二窗口处可各设置1个环形的显影部160,也或者设置至少一个“O”形或“8”形的显影部160。
实施例1
本实施例提供一种覆膜支架系统,该覆膜支架系统用于治疗累及腹腔干动脉A1、肠系膜上动脉A2和肾动脉A3的腹主动脉瘤A(参见图4)。如图3、图5所示,覆膜支架100包括依次连接的近端覆膜支架100a、中间覆膜支架100b及远端覆膜支架100c,中间覆膜支架100b的内径最小;近端覆膜支架100a与中间覆膜支架100b的交界处的两个第一窗口在轴向上各自安装有第一内嵌分支140,中间覆膜支架100b与远端覆膜支架100c的交界处的两个第二窗口各自安装有第二内嵌分支150,两个第一窗口周向并排分布在覆膜支架100的同侧,且轴向上间距为零,两个第二窗口周向并排分布在覆膜支架100的对侧,且轴向上间距为零。其中,覆膜支架100的覆膜120的材质选取涤纶织物(即PET)、聚四氟乙烯或其他高分子材料,渗透量满足0~500mL/cm2/min的要求;覆膜支架100的金属支架110采用镍钛合金丝或不锈钢材质制成,包括间隔设置的多个支撑环,支撑环由多个V型单元连接而成,覆膜支架100近端设置有裸金属支架130,利于近端锚定。
图6中的束缚线圈220借助导向丝210通过覆膜支架100上的固定线圈170绑扎,即束缚线圈220沿周向穿设于对应的固定线圈170中,将覆膜支架100束径,即导向丝210沿覆膜支架100的轴向贯穿于束缚线圈220中,其束径比例为60%(即覆膜支架100束缚后的内径与释放后的内径的比值为3:5)。其中,固定线圈170位于近端覆膜支架100a、中间覆膜支架100b及远端覆膜支架100c的中间位置,近端覆膜支架100a、中间覆膜支架100b及远端覆膜支架100c均设置有4个线圈。
治疗时,先利用输送系统将覆膜支架100输送至腹主动脉瘤A的病变部位。根据显影部160的标识定位,当判断覆膜支架100导入至病变部位时,先回撤输送系统的外管直至完全显露覆膜支架100,以将覆膜支架100释放至病变部位。利用输送系统将第一分支覆膜支架300由近端覆膜支架100a的近端导入至第一内嵌分支140中,此时因在束径状态且有裸金属支架130后释放,覆膜支架100可根据实际情况可进行微调,即此时若第一分支覆膜支架300定位不准确,可在近、远端之间微调覆膜支架100,直至第一分支覆膜支架300定位准确,之后先抽拉导向丝210对近端覆膜支架100a进行释放(如图2所示),使近端覆膜支架100a与血管贴合,然后释放第一分支覆膜支架300。重复上述步骤,即利用输送系统将第二分支覆膜支架400由远端覆膜支架100c的远端导入至第二内嵌分支150中,此时因在束径状态且有裸金属支架130后释放,覆膜支架100可根据实际情况可进行微调,即此时若第二分支覆膜支架400定位不准确,可在近、远端之间微调覆膜支架100,直至第二分支覆膜支架400定位准确,之后先抽拉导向丝210对中端覆膜支架100b、远端覆膜支架100c进行释放,使中端覆膜支架100b、远端覆膜支架100c与血管贴合,然后释放第二分支覆膜支架400。最后 释放覆膜支架100的裸金属支架130,回撤覆膜支架100的输送系统,释放完成。
实施例2
本实施例提供一种覆膜支架系统,该覆膜支架系统用于治疗累及腹腔干动脉A1、肠系膜上动脉A2和肾动脉A3的腹主动脉瘤A(参见图4)。如图11所示,覆膜支架100由近端至远端依次包括近端覆膜支架100a、中间覆膜支架100b及远端覆膜支架100c,中间覆膜支架100b的内径最小;如图10所示,近端覆膜支架100a与中间覆膜支架100b的交界处的两个第一窗口在轴向上各自安装有第一内嵌分支140,中间覆膜支架100b与远端覆膜支架100c的交界处的两个第二窗口各自安装有第二内嵌分支150,两个第一窗口在覆膜支架100的轴向上间距为8mm且周向分布在覆膜支架100的同侧,两个第二窗口在覆膜支架100的轴向上的间距为6mm且周向分布于覆膜支架100的对侧。图10中的束缚线圈220借助导向丝210通过覆膜支架100上的固定线圈170绑扎,即束缚线圈220沿周向穿设于对应的固定线圈170中,将覆膜支架100束径,导向丝210沿覆膜支架100的轴向贯穿于束缚线圈220中,其束径比例为50%(即覆膜支架100束缚后的内径与释放后的内径的比值为1:2)。治疗时,先利用输送系统将覆膜支架100输送至腹主动脉瘤A病变部位。根据显影部160的标识定位,当判断覆膜支架100导入至病变部位时,先回撤输送系统的外管直至完全显露覆膜支架100,以将覆膜支架100置于病变部位。从颈动脉穿刺导入第一分支覆膜支架300由近端覆膜支架100a的近端穿入并通过第一内嵌分支140导入至腹腔干动脉A1和肠系膜上动脉A2中,此时观察第一分支覆膜支架300定位是否准确,若不准确,此时因在束径状态且有裸金属支架130后释放,可在近、远端之间微调覆膜支架100,直至第一分支覆膜支架300定位准确。之后先抽拉导向丝210对近端覆膜支架100a进行释放,使近端覆膜支架100a与血管贴合,然后释放第一分支覆膜支架300。重复上述步骤,即利用输送系统将第二分支覆膜支架400由远端覆膜支架100c的远端导入至第二内嵌分支150中,此时因在束径状态且有裸金属支架130后释放,覆膜支架100可根据实际情况进行微调,即此时若第二分支覆膜支架400定位不准确,可在近、远端之间微调覆膜支架100,直至第二分支覆膜支架400定位准确,之后先抽拉导向丝210对中端覆膜支架100b、远端覆膜支架100c进行释放,使中端覆膜支架100b、远端覆膜支架100c与血管贴合,然后释放第二分支覆膜支架400。最后释放覆膜支架100的裸金属支架130,回撤覆膜支架100的输送系统,释放完成。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。

Claims (19)

  1. 一种覆膜支架系统,其特征在于,所述覆膜支架系统包括:覆膜支架(100)与设置在所述覆膜支架(100)上的束径件(200);
    所述束径件(200)用于束缚所述覆膜支架(100)且能够释放所述覆膜支架(100);
    其中,所述覆膜支架(100)束缚后的内径小于释放后的内径,且束缚后的所述覆膜支架(100)具有贯通的内腔。
  2. 根据权利要求1所述的覆膜支架系统,其特征在于,所述覆膜支架(100)束缚后的内径与释放后的内径的比值为(1~4):5。
  3. 根据权利要求1所述的覆膜支架系统,其特征在于,所述束径件(200)包括:导向丝(210)以及沿所述导向丝(210)的长度方向间隔分布的多个束缚线圈(220);
    所述束缚线圈(220)用于束缚所述覆膜支架(100),所述束缚线圈(220)与所述导向丝(210)可拆卸连接,以使当抽拉所述导向丝(210)时能够释放所述覆膜支架(100)。
  4. 根据权利要求3所述的覆膜支架系统,其特征在于,所述束缚线圈(220)的材质选自PET、PTFE、ePTFE、PP中的至少一种。
  5. 根据权利要求3所述的覆膜支架系统,其特征在于,所述束缚线圈(220)以打活结的方式与所述导向丝(210)连接。
  6. 根据权利要求5所述的覆膜支架系统,其特征在于,所述束缚线圈(220)的第一端围绕所述覆膜支架(100)旋转至少一圈并从所述束缚线圈(220)的第二端穿出;
    所述导向丝(210)穿设于所述束缚线圈(220)的第一端,以将所述束缚线圈(220)系紧。
  7. 根据权利要求6所述的覆膜支架系统,其特征在于,所述多个束缚线圈(220)通过同一束缚线(M)弯折而成。
  8. 根据权利要求3所述的覆膜支架系统,其特征在于,所述覆膜支架(100)上还设置有多个固定线圈(170),所述束缚线圈(220)周向穿设于对应的所述固定线圈(170)中。
  9. 根据权利要求8所述的覆膜支架系统,其特征在于,所述固定线圈(170)包括沿所述覆膜支架(100)的轴向设置的多个固定线圈组,每个所述固定线圈组绕所述覆膜支架(100)的周向分布且每个所述固定线圈组的固定线圈数目至少为3个。
  10. 根据权利要求8所述的覆膜支架系统,其特征在于,所述覆膜支架(100)包括:金属支架(110)与覆盖于所述金属支架(110)上的覆膜(120);
    所述金属支架(110)与所述覆膜(120)间的缝合线向所述覆膜支架(100)的外部拉出,以形成所述固定线圈(170)。
  11. 根据权利要求10所述的覆膜支架系统,其特征在于,所述金属支架(110)包括:沿轴向间隔设置的多个支撑环(111),所述支撑环(111)由多个支撑杆连接而成;
    所述固定线圈(170)位于所述支撑杆长度L比例为1/3~2/3的区域。
  12. 根据权利要求1所述的覆膜支架系统,其特征在于,所述束径件(200)通过束缚线编织而成并以过盈配合的方式套于所述覆膜支架(100)的外部。
  13. 根据权利要求1~12任一项所述的覆膜支架系统,其特征在于,所述覆膜支架(100)由近端至远端依次包括:近端覆膜支架(100a)、中间覆膜支架(100b)及远端覆膜支架(100c),所述中间覆膜支架(100b)的内径最小;
    所述近端覆膜支架(100a)与所述中间覆膜支架(100b)的交界处设置有至少一个第一窗口,所述中间覆膜支架(100b)与所述远端覆膜支架(100c)的交界处设置有至少一个第二窗口,所述第一窗口与所述第二窗口均用于安装分支覆膜支架。
  14. 根据权利要求13所述的覆膜支架系统,其特征在于,所述第一窗口处设置有第一内嵌分支(140),所述第二窗口处设置有第二内嵌分支(150),所述第一内嵌分支(140)与所述第二内嵌分支(150)均位于所述覆膜支架(100)内。
  15. 根据权利要求13所述的覆膜支架系统,其特征在于,所述第一窗口的数目为两个,两个所述第一窗口周向分布在所述覆膜支架(100)的同侧,且相邻两个所述第一窗口在所述覆膜支架(100)轴向上的间距为0~30mm。
  16. 根据权利要求13所述的覆膜支架系统,其特征在于,所述第二窗口的数目为两个,两个所述第二窗口周向分布在所述覆膜支架(100)的对侧,且相邻两个所述第二窗口在所述覆膜支架(100)轴向上的间距为0~30mm。
  17. 根据权利要求13所述的覆膜支架系统,其特征在于,所述近端覆膜支架(100a)的近端边缘、和/或所述远端覆膜支架(100c)的远端边缘、和/或所述第一窗口、和/或所述第二窗口设置有显影部(160)。
  18. 根据权利要求17所述的覆膜支架系统,其特征在于,所述显影部(160)通过缝合线缝合固定。
  19. 根据权利要求17所述的覆膜支架系统,其特征在于,所述显影部(160)的材质选取钽、铂铱合金、黄金中的至少一种。
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