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WO2025103432A1 - Endoprothèse recouverte - Google Patents

Endoprothèse recouverte Download PDF

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Publication number
WO2025103432A1
WO2025103432A1 PCT/CN2024/132153 CN2024132153W WO2025103432A1 WO 2025103432 A1 WO2025103432 A1 WO 2025103432A1 CN 2024132153 W CN2024132153 W CN 2024132153W WO 2025103432 A1 WO2025103432 A1 WO 2025103432A1
Authority
WO
WIPO (PCT)
Prior art keywords
wave
stent
type
segment
stent segment
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/CN2024/132153
Other languages
English (en)
Chinese (zh)
Inventor
雷文斌
李明华
谢志永
�田�浩
郑雪妮
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Microport Neurotech Shanghai Co Ltd
Original Assignee
Microport Neurotech Shanghai Co Ltd
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
Publication date
Application filed by Microport Neurotech Shanghai Co Ltd filed Critical Microport Neurotech Shanghai Co Ltd
Publication of WO2025103432A1 publication Critical patent/WO2025103432A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes

Definitions

  • the present invention relates to the technical field of medical devices, and more specifically, to a cutting-type stent graft.
  • Cardiovascular and cerebrovascular diseases are important diseases that affect human health, among which aneurysms are the most common and endanger human health at all times.
  • Covered stents have become more and more widely used stents due to their inherent advantage of immediate occlusion, especially in lesions such as the thoracic aorta, abdominal aorta, heart valves, and carotid arteries. They can be used to isolate aneurysms and guide blood to flow along normal blood vessels.
  • the purpose of the present invention is to provide a coated stent, aiming to improve various performances of the coated stent.
  • the present invention provides a coated stent, which includes a cutting stent and a coating
  • the cutting stent is defined by a plurality of wave rods
  • the plurality of wave rods are arranged in sequence along the axial direction of the cutting stent, and any adjacent wave rods are connected by a plurality of circumferentially distributed connecting rods
  • the cutting stent includes a distal bare stent segment, a coated stent segment and a proximal bare stent segment which are arranged in sequence along its own axial direction from the distal end to the proximal end
  • the coating is coated on at least a portion of the outer surface of the coated stent segment
  • the coated stent segment is an open-loop structure
  • at least one of the distal bare stent segment and the proximal bare stent segment is a closed-loop structure.
  • the wave rods include a first type of wave rod and a second type of wave rod
  • the size of the first type of wave rod is larger than that of the second type of wave rod
  • the wave rods in the distal bare stent segment and the proximal bare stent segment are both composed of the second type of wave rods
  • the wave rods in the coated stent segment are composed of the first type of wave rod and the second type of wave rod
  • the ratio of the number of wave heads of the first type of wave rod to the number of wave heads of the second type of wave rod is 1:1.5.
  • the first-type wave rods and the second-type wave rods in the coated stent segment are alternately distributed along the axial direction of the cutting stent, so that a first-type wave rod is provided every interval of a second-type wave rod, and the proximal and distal ends of the coated stent segment are both the first-type wave rods.
  • the number of the second-type wave bars in the distal bare stent segment is 2 to 10, and/or the number of the second-type wave bars in the proximal bare stent segment is 1 to 5.
  • the number of wave heads of the first type of wave rod in the coated stent segment is 6 to 10
  • the number of wave heads of the second type of wave rod in the coated stent segment is 8 to 16
  • the number of connecting rods connected to adjacent first type of wave rods and second type of wave rods in the coated stent segment is 3 to 6, and are evenly distributed along the circumference of the cutting stent.
  • the number of wave heads of the first type of wave rod in the coated stent segment is 8
  • the number of wave heads of the second type of wave rod in the coated stent segment is 12
  • adjacent first type of wave rods and second type of wave rods in the coated stent segment are connected by 4 connecting rods.
  • the length of the stent graft segment is 4 mm to 30 mm.
  • the proximal end of the coating is arranged on the open-loop structure, and the distal end of the coating is arranged on the closed-loop structure.
  • some of the wave rods include a first type of wave rod and a second type of wave rod, the size of the first type of wave rod is larger than that of the second type of wave rod, the wave rods in the distal bare stent segment and the proximal bare stent segment are both composed of the second type of wave rod, the wave rod in the coated stent segment is composed of the first type of wave rod and the second type of wave rod, the proximal end of the coating is arranged on the first type of wave rod at the proximal end of the coated stent segment, the distal end of the coating is arranged on the second type of wave rod of the distal bare stent segment, and the distal bare stent segment is a closed-loop structure.
  • the distal end of the coating is arranged on the second-to-last or third-to-last second-type wave rod of the distal bare stent segment counting from the distal end to the proximal end.
  • the coated stent also includes a plurality of fixed membranes, all of which are arranged in the lumen of the cutting stent and fit on the inner surface of the cutting stent, the proximal end and the distal end of the coating are respectively connected to a plurality of the fixed membranes, the plurality of fixed membranes connected to either end of the coating are distributed along the circumference of the cutting stent, and each fixed membrane is not fixed to the wave rod it covers.
  • the stent graft also has at least one of the following characteristics:
  • the distal bare stent segment is provided with a plurality of imaging points distributed along its circumference;
  • the proximal bare stent segment is provided with a plurality of imaging points distributed along its circumference;
  • At least one of the proximal end and the distal end of the stent graft segment is provided with a plurality of developing points distributed along the circumference thereof.
  • the distal bare stent segment and the proximal bare stent segment are both closed-loop structures.
  • the stent graft provided by the present invention has at least the following advantages:
  • the stability and support of the stent graft are improved by the closed-loop structure of at least one of the distal bare stent segment and the proximal bare stent segment, and the flexibility and wall-adherence of the stent graft at the coating position are improved by the open-loop structure of the stent graft segment, so that the stent graft can take into account flexibility, anchoring and wall-adherence.
  • the coating only covers the outer surface of the stent graft segment to form a single-layer and partial coating, the influence of the coating on the cutting stent can be reduced, the flexibility of the stent graft and the effectiveness of the coating can be ensured, and the thickness of the stent can be not increased, so that the stent graft can be transported and enter smaller blood vessels.
  • the flexibility of the coated stent is further increased by the second type of wave rod, and the support of the coated stent is further increased by the first type of wave rod, so that the support and stability of both ends of the coated stent are better, and the flexibility and support of the coated position can be better taken into account.
  • the proximal end of the graft is arranged on an open-loop structure, and the distal end of the graft is arranged on a closed-loop structure, so that the distal end of the graft can be recovered and repositioned.
  • the grafted stent of the present invention can further take into account the recovery performance and positioning performance on the basis of taking into account the flexibility, anchoring and wall adhesion.
  • the number of the second-type wave rods in the distal bare stent segment is 2 to 10, which is beneficial for recovering the covered stent using the distal bare stent segment after the distal end of the covered stent segment and the distal end of the coating are released, and then releasing the covered stent after readjusting the position, thereby ensuring the effectiveness and accuracy of isolating blood vessels and blood flow.
  • the number of the second type of wave rods in the proximal bare stent segment is 1 to 5, which is beneficial for the proximal end to not block the branch blood vessels after the covered stent is fully released, thereby ensuring smooth blood flow in the branch blood vessels.
  • the length of the stent graft segment is 4 mm to 30 mm. In this way, the stent graft can be used to isolate most target objects such as aneurysms, etc., ensuring its scope of application.
  • FIG1 is a schematic structural diagram of a cutting bracket provided according to an embodiment of the present invention.
  • FIG2 is a schematic diagram of the structure of a stent graft provided according to an embodiment of the present invention.
  • FIG3 is a schematic diagram of the installation of a plurality of fixed membranes connected to the proximal end of the covering membrane according to an embodiment of the present invention
  • FIG. 4 is a schematic diagram of the installation of a plurality of fixed membranes connected to the distal end of the covering according to an embodiment of the present invention.
  • 100-cutting stent 100-cutting stent; 101-wave rod; 1011-first type wave rod; 1012-second type wave rod; 102-connecting rod; 103-development point; 110-distal bare stent segment; 120-coated stent segment; 130-proximal bare stent segment; 200-coating; 300-fixed membrane.
  • diameter refers to “outer diameter”
  • axial refers to the direction along the central axis of the stent graft
  • circumferential refers to the direction around the central axis of the stent graft
  • radial refers to the direction perpendicular to the central axis of the stent graft, that is, the diameter direction.
  • proximal refers to the end of the stent graft that is close to the surgical operator when it is delivered
  • distal refers to the end of the stent graft that is away from the surgical operator when it is delivered.
  • the "length” and “diameter” described in this application document are the dimensions of the stent graft in the expanded state.
  • “not exceeding” described in this application document means less than or equal to.
  • “inside” refers to the side close to the inner surface of the stent graft; “outside” refers to the side close to the outer surface of the stent graft; the dimension from the inner surface to the outer surface of the stent graft is defined as the thickness of the stent graft.
  • the core idea of the present invention is to provide a coated stent, aiming to take into account various aspects of performance, especially thickness, flexibility, anchoring, wall adhesion, recovery performance, positioning performance, and transportation performance, so as to better apply the coated stent.
  • coated stent provided by the present invention can be expanded by itself or with the help of external force, and the present invention has no special requirements for this.
  • the stent graft provided by the present invention has at least a contracted state and an expanded state, and can switch between the contracted state and the expanded state; the stent graft is in the contracted state when being transported in the transport system, and in the contracted state, the stent graft is axially stretched, which is conducive to transport and entering small blood vessels; the stent graft is in the expanded state after being released from the transport system.
  • the expanded state includes the natural expanded state of the stent graft when there is no external force constraint and the expanded state when there is an external force constraint.
  • the stent graft provided by the present invention may be used to treat a variety of medical conditions, including but not limited to the treatment of aneurysms, and while the stent graft may be particularly helpful in treating aneurysms, it is not limited to such treatment.
  • the coated stent provided by the present invention includes a cutting stent 100 and a coating 200.
  • the cutting stent 100 is a three-dimensional mesh structure and is defined by a plurality of wave rods 101, which are annular and mostly sawtooth or sinusoidal.
  • the plurality of wave rods 101 are arranged in sequence along the axial direction of the cutting stent 100, and any adjacent wave rods 101 are connected by a plurality of circumferentially distributed connecting rods 102, and each connecting rod 102 connects the crests and troughs of adjacent wave rods 101.
  • the connecting rod 102 can support and reduce the deflection of the stent.
  • the crests or troughs on the same wave rod 101 are defined as wave heads.
  • the cutting stent 100 is generally carved from a pipe, and its material is not limited. It is generally selected from materials with good elasticity such as stainless steel and nickel-titanium alloy, but it is not actually limited to this.
  • the coating 200 is coated on the outer surface of the cutting stent 100 and is used to immediately block the target object (such as a blood vessel, an aneurysm, etc.).
  • the coating 200 is only coated on part of the outer surface of the cutting stent 100 to achieve partial coating and single-sided coating.
  • This partial coating and single-sided coating i.e., single-layer coating reduces the impact of the coating 200 on the cutting stent 100, ensures the flexibility of the coated stent and the effectiveness of the coating 200, and does not increase the thickness of the coated stent, so that the coated stent can be delivered and enter smaller blood vessels.
  • the cutting stent 100 includes a distal bare stent segment 110, a coated stent segment 120, and a proximal bare stent segment 130, which are sequentially arranged along the axial direction from the distal end to the proximal end.
  • the coating 200 is coated on at least part of the outer surface of the coated stent segment 120, the proximal bare stent segment 130 is basically not provided with the coating 200, and the proximal end of the distal bare stent segment 110 may be covered by the coating 200. Except for the proximal part of the distal bare stent segment 110, the rest of the distal bare stent segment 110 is not provided with the coating 200. It should be noted that in order to facilitate the recovery and fixation of the coating 200, in a preferred embodiment of the present invention, the distal end of the coating 200 extends to cover the proximal end of the distal bare stent segment 110.
  • the length of the stent graft segment 120 is 4 mm to 30 mm.
  • the stent graft of the present invention can be used to isolate most target objects such as aneurysms, ensuring its scope of application.
  • At least one of the distal bare stent segment 110 and the proximal bare stent segment 130 is a closed-loop structure
  • the coated stent segment 120 is an open-loop structure.
  • the closed-loop structure means that the number of connecting rods 102 is the same as the number of wave heads on the wave rod 101 connected to the connecting rod 102. After the closed-loop structure is set, the stability and support of the coated stent are increased. Preferably, if the release position is not suitable, the distal end of the coated stent can also be recovered.
  • the open-loop structure means that the number of connecting rods 102 is less than the number of wave heads on the wave rod 101 connected to the connecting rod 102.
  • the distal bare stent segment 110 and the proximal bare stent segment 130 are both closed-loop structures.
  • the distal bare stent segment 110 is an open-loop structure
  • the proximal bare stent segment 130 is a closed-loop structure.
  • the wave rods 101 on the cutting stent 100 may all be second-type wave rods 1012, and the second-type wave rods 1012 are small wave rods.
  • the small wave rods are small in size and can improve the compliance of the coated stent.
  • the plurality of wave rods 101 on the cutting stent 100 include a first type of wave rod 1011 and a second type of wave rod 1012, wherein the first type of wave rod 1011 is a large wave rod, and the size of the first type of wave rod 1011 is larger than the size of the second type of wave rod 1012.
  • the size here includes wave height and wave width (i.e., rod width), the distance from the wave crest to the wave trough (i.e., wave height) in the first type of wave rod 1011 is larger than the distance from the wave crest to the wave trough (i.e., wave height) in the second type of wave rod 1012, and the width of the first type of wave rod 1011 (i.e., rod width) is larger than the width of the second type of wave rod 1012.
  • the first type of wave rod 1011 can improve the support and anchoring performance of the coated stent.
  • the wave rods 101 in the coated stent segment 120 are first-type wave rods 1011 and second-type wave rods 1012, and both the distal bare stent segment 110 and the proximal bare stent segment 130 use the second-type wave rods 1012.
  • the wave rods 101 in the coated stent segment 120 all use the second-type wave rods 1012.
  • the wave rods 101 in the coated stent segment 120 are composed of the first-type wave rods 1011 and the second-type wave rods 1012, so that the flexibility and support of the coated position can be balanced, and the performance is better.
  • the first type of wave rod 1011 and the second type of wave rod 1012 in the coated stent segment 120 are alternately distributed along the axial direction of the cutting stent 100, that is, a first type of wave rod 1011 is arranged every second type of wave rod 1012, and the proximal end and the distal end of the coated stent segment 120 are both the first type of wave rod 1011, so that the proximal end of the coated stent segment 120 is connected to the proximal bare stent segment 130 through the first type of wave rod 1011, and the distal end of the coated stent segment 120 is connected to the distal bare stent segment 110 through the first type of wave rod 1011.
  • the wave rod 101 in the distal bare stent segment 110 is composed of the second type of wave rod 1012, that is, all wave rods are used, and the distal bare stent segment 110 is preferably a closed-loop structure; in this way, on the basis of ensuring the support through the closed-loop structure of the distal bare stent segment 110, the wall adhesion performance of the distal bare stent segment 110 can be increased through the wave rod design, and at the same time, the distal end of the coated stent can be recovered and repositioned through the closed-loop wavelet design of the distal bare stent segment 110, and the blocking of branch blood vessels after the distal end of the coated stent is avoided.
  • the distal end of the coated stent can also be recovered through the closed-loop wavelet design of the distal bare stent segment 110.
  • All the wave rods 101 in the proximal bare stent segment 130 adopt the second type wave rod 1012, and the proximal bare stent segment 130 is preferably a closed-loop structure; in this way, the closed-loop wavelet design of the proximal bare stent segment 10 can provide more connection points with the delivery system, further increasing the stability of the coated stent.
  • the ratio of the number of wave heads (defined as a) of the first type of wave rod 1011 to the number of wave heads (defined as b) of the second type of wave rod 1012 in the cutting stent 100 is 1:1.5.
  • the performance of the stent graft of the present invention is in the optimal state in all aspects.
  • the degree of freedom of the open-loop wave rod of the coated stent segment 120 can be used to improve the bending and wall-adhering performance of the coated stent segment to prevent internal leakage, and the large wave rod in the coated stent segment 120 can be used to ensure the support and anchoring force of the coated segment.
  • the small wave rod in the coated stent segment 120 can be used to improve the flexibility of the stent, and combined with the distal bare stent segment 110 and the proximal bare stent segment 130, the recyclability and repeatable positioning of the coated stent can be achieved.
  • the number (i.e., wave number) of the wave bars 101 (i.e., the second type of wave bars 1012) of the distal bare stent segment 110 along the axial direction of the cutting stent 100 is preferably 2 to 10, and more preferably, the wave number is 5 to 8.
  • the coated stent can be recovered by using the distal bare stent segment 110, and the coated stent can be released after adjusting the position, thereby ensuring the effectiveness and accuracy of isolating the blood vessel and blood flow.
  • the number (i.e., wave number) of the proximal bare stent segment 130 along the axial direction of the cutting stent 100 is preferably 1 to 5, and more preferably, the wave number is 2 to 3. In this way, after the covered stent is completely released, the branch blood vessels are not blocked, ensuring smooth blood flow in the branch blood vessels.
  • the number of wave heads of the first type wave rod 1011 in the coated stent segment 120 can be 6 to 10, and the more suitable number is 8.
  • the number of wave heads of the second type wave rod 1012 in the coated stent segment 120 can be 8 to 16, and the more suitable number is 12.
  • the number of wave heads of the first type wave rod 1011 in the coated stent segment 120 is 8
  • the number of wave heads of the second type wave rod 1012 in the coated stent segment 120 is 12
  • the adjacent first type wave rods 1011 and second type wave rods 1012 in the coated stent segment 120 are connected by 4 connecting rods 102, and the 4 connecting rods 102 are evenly distributed along the circumference of the cutting stent 100.
  • the number of connecting rods 102 connected to the adjacent first-type wave rods 1011 and second-type wave rods 1012 in the coated stent segment 120 is 3 to 6.
  • the number of connecting rods 102 connected to the adjacent first-type wave rods 1011 and second-type wave rods 1012 in the coated stent segment 120 is generally half the number of wave heads of the first-type wave rod 1011, so as to take into account both support and flexibility.
  • the number of wave rods 101 in the coated stent segment 120 can be determined according to the length of the target object to be isolated. Generally, the number of wave rods 101 (total number) in the coated stent segment 120 can be 4 to 20.
  • the length of the coating 200 is 7-30 mm
  • the length of the proximal bare stent segment 130 is 0.8-4 mm
  • the length of the distal bare stent segment 110 is 0.8-8 mm.
  • the coated stent can be applied to most patients or individuals.
  • the diameter of the distal bare stent segment 110 and the diameter of the proximal bare stent segment 130 are both larger than the diameter of the coated stent segment 120.
  • the diameter of the distal bare stent segment 110 and the diameter of the proximal bare stent segment 130 are 1.0 to 1.5 times the diameter of the coated stent segment 120.
  • at least one of the distal bare stent segment 110 and the proximal bare stent segment 130 is a flare. After the flare is set, the distal end and the proximal end of the coated stent can play a better anchoring role after the stent is opened.
  • the proximal end of the coating 200 is arranged on an open-loop structure, and the distal end of the coating 200 is arranged on a closed-loop structure, so that the distal end of the coated stent can be recovered and repositioned.
  • the proximal end of the coating 200 is arranged on the first type of wave bar 1011 at the proximal end of the coated stent segment 120, so that a stronger supporting force can be provided by the first type of wave bar 1011; and the distal end of the coating 200 is preferably arranged on the second type of wave bar 1012 of the distal bare stent segment 110, and more preferably, the distal end of the coating 200 is arranged on the penultimate, second to last, or third to last second type of wave bar 1012 counting from the distal end to the proximal end of the distal bare stent segment 110, so that the distal end of the coated stent can be recovered.
  • the proximal end and the distal end of the coating 200 can be directly sutured to the cutting stent 100 or without suture.
  • the coated stent further includes a plurality of fixed membranes 300, all of which are arranged in the lumen of the cutting stent 100 and are attached to the inner surface of the cutting stent 100, and then the proximal end and the distal end of the coating 200 are respectively connected to the plurality of fixed membranes 300, and the plurality of fixed membranes 300 connected to either end of the coating 200 are distributed along the circumference of the cutting stent 100, usually evenly distributed along the circumference.
  • the coating 200 and the fixed membrane 300 can be connected by hot melt connection, glue bonding, suture connection or other connection methods, preferably by hot melt connection. During hot melt connection, the coating is not likely to cause deformation of the stent, thereby reducing the risk of deformation of the stent, making the reliability and stability of the stent better, and the performance better.
  • multiple fixed membrane sheets 300 connected to the proximal end of the coating 200 are attached to the first type of wave rod 1011 at the nearest end of the coated stent segment 120.
  • the first type of wave rod 1011 has a large supporting force and is easy to open and anchor, thereby allowing the proximal end of the coating 200 to adhere better to the wall to prevent internal leakage.
  • a plurality of fixed membrane sheets 300 connected to the distal end of the coating 200 are adhered to the inner surface of the distal bare stent segment 110.
  • these fixed membrane sheets 300 are arranged on the second-to-last to third-to-last second-type wave rods 1012 of the distal bare stent segment 110 counting from the distal end to the proximal end. This is beneficial for the distal end of the coated stent to be recovered and repositioned for release when the distal end of the coated stent is opened and anchored.
  • the size of the fixed membrane 300 is very small, much smaller than the coating 200. Therefore, the fixed membrane 300 does not increase the thickness of the stent and can also minimize the impact on the cutting stent 100.
  • the thickness of the fixed membrane 300 does not exceed the thickness of the coating 200.
  • the fixed membrane 300 can be directly connected to the external coating 200 through the mesh on the cutting stent 100. When connected, the fixed membrane 300 is kept flat so that the edge of the fixed membrane 300 is completely integrated with the coating 200. This coating method will not significantly increase the thickness of the coated stent. Because the fixed membrane 300 is set in the lumen of the cutting stent 100, it does not affect the appearance of the coated stent and also improves the flexibility of the coated stent.
  • each fixed diaphragm 300 is not fixed to the wave bar 101 covered by the fixed diaphragm 300, so that the fixed diaphragm 300 can move relative to the covered wave bar 101.
  • the influence of the fixed diaphragm 300 and the coating 200 on the cutting stent 100 can be reduced, and the problems of wrinkles, ruptures, etc. in the coating 200 can be avoided, and the effectiveness of the coating 200 can be further guaranteed.
  • the fixed diaphragm 300 is connected to the coating 200 by hot melting, the middle part of the fixed diaphragm 300 is not fixed to the covered wave bar 101, and the side part of the fixed diaphragm 300 is fixed to the coating 200 by hot melting through the mesh. Therefore, do not hot melt near the wave bar 101 to avoid affecting the expansion and contraction of the stent.
  • these fixed membranes 300 can be arranged with one or more peaks or troughs spaced apart, or can be arranged without peaks or troughs spaced apart (i.e., directly adjacent to each other), and the fixed membranes 300 and the fixed membranes 300 do not overlap, and are all independently arranged.
  • the multiple fixed membranes 300 connected to either end of the coating 200 are evenly distributed along the circumference of the cutting bracket 100, so that the coating 200 is evenly stressed and less prone to more wrinkles.
  • the number of fixed membranes 300 is minimized to avoid increasing the thickness of the coating bracket.
  • 2 to 6 fixed membranes 300 are connected to either end of the coating 200.
  • the multiple fixed diaphragms 300 connected to either end of the coating 200 are sequentially distributed in the circumferential direction of the cutting stent 100, and these fixed diaphragms 300 can be aligned or staggered in the axial direction of the cutting stent 100.
  • axial alignment means that the multiple fixed diaphragms 300 are arranged on the same circumference. In this case, the multiple fixed diaphragms 300 can be arranged at the same position of the multiple wave bars 101 in the circumferential direction.
  • Axial staggering means that the multiple fixed diaphragms 300 are arranged on different circumferences, so that the multiple fixed diaphragms 300 are arranged at different positions of the multiple wave bars 101 in the circumferential direction.
  • the multiple fixed diaphragms 300 connected to either end of the coating 200 are aligned in the axial direction to avoid the risk of the coating 200 warping due to uneven ends, thereby reducing the risk of thrombosis.
  • the fixed diaphragm 300 is usually only arranged on the rod section between adjacent wave crests and wave troughs at a certain position of the wave rod 101, and the rod section may be covered with one or more fixed diaphragms 300.
  • the multiple fixed diaphragms 300 connected to any end of the coating 200 may be partially staggered or completely staggered.
  • the multiple fixed diaphragms 300 may have various geometric arrangement paths, such as zigzag, wavy, etc., which are not specifically limited.
  • multiple fixed diaphragms 300 may be further connected at a certain position between the proximal end and the distal end of the coating 200 to better fix the coating 200.
  • the fixed film 300 when the fixed film 300 is set, the fixed film 300 can be blocked by the bending part (i.e., wave crest or wave trough) on the wave rod 101 to prevent the fixed film 300 from having a large displacement, and the fixed film 300 will not slip off the covered wave rod 101 during the stent stretching process, and the fixed film 300 will only move on the rod section between two adjacent wave crests and wave troughs. In this way, it can be ensured that the film 200 does not have a large displacement when the stent is stretched, and the relative position of the film 200 and the cutting stent 100 does not change significantly, thereby avoiding excessive wrinkles of the film 200 to cause thrombosis.
  • the bending part i.e., wave crest or wave trough
  • the material of the fixed diaphragm 300 is the same as or different from that of the coating 200.
  • the coating 200 is made of a common polymer material.
  • the coating 200 is made of expanded polytetrafluoroethylene (ePTFE), polyester (PET), polyurethane (TPU), polylactic acid (PLA) or other polymer materials.
  • ePTFE expanded polytetrafluoroethylene
  • PET polyester
  • TPU polyurethane
  • PLA polylactic acid
  • the bonding strength between the fixed diaphragm 300 and the coating 200 is better when hot-melted, and the effectiveness of the fixed coating 200 can be improved while ensuring the hot-melt strength.
  • after adding the fixed diaphragm 300 there is no need to add biological evaluation tests, which is convenient to use.
  • a plurality of developing points 103 are provided on the cutting stent 100 to facilitate the positioning of the coating 200 and both ends of the stent, thereby more accurately releasing the coating 200 at the target position, such as at the neck of the aneurysm, to facilitate immediate occlusion of the aneurysm.
  • a plurality of developing points 103 are provided on the distal bare stent segment 110. In some embodiments, a plurality of developing points 103 are provided on the proximal bare stent segment 130. In some embodiments, a plurality of developing points 103 are provided on at least one of the proximal end and the distal end of the coated stent segment 120.
  • the developing points 103 at corresponding positions are usually distributed along the circumference of the stent so as to judge the circumferential adhesion of the coated stent.
  • the developing points 103 can be developed under radiation, and can be realized by using a developing spring, a developing spring or other structures, which is not limited in this application.
  • a plurality of developing points 103 are provided along the circumferential direction on a first-type wave bar 1011 at the most proximal end of the coated stent segment 120.
  • These developing points 103 and the fixed film 300 are provided on the same wave bar 101.
  • the developing points 103 and the fixed film 300 are provided alternately without interfering with each other.
  • the proximal end of the coating 200 is fixed on the first-type wave bar 1011 at the most proximal end of the coated stent segment 120, so that the proximal end of the coating 200 can be located by these developing points 103.
  • the stent graft of the present invention has at least the following advantages:
  • the first type of wave rods in the stent graft segment improve the support and anchoring properties of the stent graft, while the second type of wave rods in the stent graft segment improve the flexibility of the stent graft.
  • the closed-loop wavelet of the distal bare stent segment is used to achieve the distal retrievability and repositioning of the stent graft, and to avoid blocking the branch vessels after the distal end of the stent graft is released. This allows the stent graft to have better recovery and positioning performance without blocking the branch vessels.
  • the bending parts (peaks and troughs) on the wave rod are used to block the fixed membrane to prevent the fixed membrane from making a large displacement, so that the two ends of the membrane can only move in a relatively small area, which better fixes the relative position of the membrane on the wave rod and avoids excessive wrinkles of the membrane causing thrombosis.
  • the covering method of the fixed film is simpler and easier to mechanize, which is convenient for simplifying the manufacturing process of the covered stent and improving production efficiency.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Prostheses (AREA)

Abstract

Une endoprothèse recouverte comprend une endoprothèse découpée (100) et une membrane de recouvrement (200). L'endoprothèse découpée est définie pour présenter une pluralité d'entretoises ondulées (101) ; les entretoises ondulées sont agencées de manière séquentielle dans la direction axiale de l'endoprothèse découpée ; deux entretoises ondulées adjacentes quelconques sont reliées au moyen d'une pluralité de tiges de liaison (102) réparties dans la direction circonférentielle ; l'endoprothèse découpée comprend un segment d'endoprothèse nu distal (110), un segment d'endoprothèse recouvert (120) et un segment d'endoprothèse nu proximal (130), agencés séquentiellement de l'extrémité distale à l'extrémité proximale dans la direction axiale de l'endoprothèse découpée ; la membrane de recouvrement recouvre au moins une partie de la surface extérieure du segment d'endoprothèse recouvert ; le segment d'endoprothèse recouvert est d'une structure en boucle ouverte, et au moins l'un du segment d'endoprothèse nu distal et du segment d'endoprothèse nu proximal est d'une structure en boucle fermée. L'endoprothèse couverte peut assurer à la fois la souplesse et le soutien et présente ainsi une meilleure applicabilité.
PCT/CN2024/132153 2023-11-17 2024-11-15 Endoprothèse recouverte Pending WO2025103432A1 (fr)

Applications Claiming Priority (2)

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CN202311548022 2023-11-17
CN202311548022.7 2023-11-17

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WO2025103432A1 true WO2025103432A1 (fr) 2025-05-22

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080009829A1 (en) * 2006-07-07 2008-01-10 Abbott Cardiovascular Systems Inc. Balloon catheter having a branched distal section with secured branches
US20140025151A1 (en) * 2012-07-20 2014-01-23 Bulang Gao Retrievable stent for intracranial aneurysms
CN108969148A (zh) * 2017-06-05 2018-12-11 先健科技(深圳)有限公司 医用覆膜支架
CN110721013A (zh) * 2018-07-16 2020-01-24 杭州唯强医疗科技有限公司 一种分段式裸支架
CN113116611A (zh) * 2019-12-30 2021-07-16 微创神通医疗科技（上海）有限公司 医用支架以及覆膜支架
CN113855349A (zh) * 2020-06-29 2021-12-31 深圳市先健畅通医疗有限公司 管腔支架
CN114948334A (zh) * 2022-04-11 2022-08-30 上海玮琅医疗科技有限公司 一种肺动脉覆膜支架

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080009829A1 (en) * 2006-07-07 2008-01-10 Abbott Cardiovascular Systems Inc. Balloon catheter having a branched distal section with secured branches
US20140025151A1 (en) * 2012-07-20 2014-01-23 Bulang Gao Retrievable stent for intracranial aneurysms
CN108969148A (zh) * 2017-06-05 2018-12-11 先健科技(深圳)有限公司 医用覆膜支架
CN110721013A (zh) * 2018-07-16 2020-01-24 杭州唯强医疗科技有限公司 一种分段式裸支架
CN113116611A (zh) * 2019-12-30 2021-07-16 微创神通医疗科技（上海）有限公司 医用支架以及覆膜支架
CN113855349A (zh) * 2020-06-29 2021-12-31 深圳市先健畅通医疗有限公司 管腔支架
CN114948334A (zh) * 2022-04-11 2022-08-30 上海玮琅医疗科技有限公司 一种肺动脉覆膜支架

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