WO2020024936A1 - 高柔顺性支架 - Google Patents
高柔顺性支架 Download PDFInfo
- Publication number
- WO2020024936A1 WO2020024936A1 PCT/CN2019/098375 CN2019098375W WO2020024936A1 WO 2020024936 A1 WO2020024936 A1 WO 2020024936A1 CN 2019098375 W CN2019098375 W CN 2019098375W WO 2020024936 A1 WO2020024936 A1 WO 2020024936A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- wave
- support
- connecting member
- flexible connecting
- support unit
- Prior art date
Links
Images
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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/02—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
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
Definitions
- the invention belongs to the technical field of medical devices, and particularly relates to a stent, in particular to a highly compliant stent which can be used for intraluminal interventional therapy.
- Peripheral vascular disease is a common manifestation of systemic atherosclerosis, and its incidence has increased significantly in recent years. Common examples include arteriosclerotic occlusive disease, arteriovenous thrombosis, and aneurysms. Can induce systemic arteriosclerosis and cardiovascular morbidity and mortality. After the occurrence of peripheral vascular lesions, the vascular cavity becomes narrow, the blood flow into the lower limbs becomes smaller, which causes insufficient blood supply to the lower limbs, causing limb necrosis and other phenomena.
- peripheral vascular diseases include medical treatment and surgical treatment.
- medical treatment blood pressure, lipid lowering, anti-platelet aggregation and other treatments can delay the progress of arterial occlusion of lower limbs, but it can not fundamentally eliminate vascular stenosis and occlusion.
- Surgical treatment divided into open surgery and endovascular interventional therapy.
- Vascular lumen interventional therapy has the advantages of minimally invasive, simple operation, accurate curative effect, and repeatable operation, and is the development direction of diagnosis and treatment of vascular diseases.
- Aortic aneurysm refers to the local or diffuse abnormal expansion of the aortic wall, which causes symptoms due to compression of surrounding organs, and its main danger is tumor rupture. It usually occurs in the ascending aorta, aortic arch, descending aorta, thoracic and abdominal aorta, and abdominal aorta.
- Aortic aneurysms can be divided into true aortic aneurysms, pseudo aortic aneurysms, and dissecting aortic aneurysms by structure.
- the aortic aneurysm causes an increase in the inner pressure of the blood vessel, so it is progressively enlarged. If it develops for a long time, it eventually ruptures. The larger the tumor, the more likely it is to rupture. According to statistics, without surgery, 90% of thoracic aortic aneurysms die within 5 years, and 3/4 abdominal aortic aneurysms die within 5 years.
- Thoracic aorta endovascular repair includes aortic dissection, aortic penetrating ulcers, aortic wall hematomas, thoracic aortic aneurysms and pseudoaneurysms, and other aortic dilatation lesions, as well as aortic surgery Or secondary endovascular treatment of TEVAR postoperative complications.
- aortic dissection includes aortic dissection, aortic penetrating ulcers, aortic wall hematomas, thoracic aortic aneurysms and pseudoaneurysms, and other aortic dilatation lesions, as well as aortic surgery Or secondary endovascular treatment of TEVAR postoperative complications.
- abdominal aortic angioplasty was reported in the 1990s for the treatment of abdominal aortic aneurysms, EVAR has spread rapidly worldwide.
- the currently used interventional devices include balloon-expandable stents and self-expanding stents.
- Self-expanding stents are currently used in vascular interventional therapy.
- Closed-loop stents are commonly used in self-expanding stents, that is, the crests and troughs between two axially adjacent support units of the stent are connected by connecting rods.
- the advantages of the closed-loop stent are that the metal coverage is large, and it has a large radial supporting force, which can evenly cover the blood vessel wall to prevent plaque from falling off. However, this design has relatively poor flexibility and cannot adapt to curved complex diseased blood vessels. .
- the vascular stent During the application of vascular stent, it is necessary to compress, transport and expand the vascular stent. Therefore, the vascular stent must have good compressibility, delivery flexibility and uniform expansion. This has proposed the material and structural design of the vascular stent. Very high requirements, the existing brackets have not yet achieved the perfect unification of these technical indicators.
- the technical problem to be solved by the present invention is to provide a highly compliant stent with good compressibility, transport flexibility and expansion uniformity.
- a high-flexibility stent includes a plurality of ring-shaped support frames arranged in an axial direction, the ring-shaped support frame is formed by end-to-end support of a plurality of wave-shaped support units, and the support units include wave crests, troughs, connected between the crests and troughs. Between two adjacent ring support frames, the peaks and troughs of a plurality of different support units are connected by a first flexible connection member, and the first flexible connection member is also extended and wound around at least one support unit A second flexible connection is formed on the top.
- the support units of different turns in the axial direction have the same wavelength, and the support units are arranged in a row corresponding to each other in the axial direction.
- a flexible connecting member is connected between the crests and troughs of the two supporting units in different axial rows.
- the first flexible connecting member is connected at the same time between the peaks of one support unit and the valleys of two adjacent rows of support units in an adjacent circle to form an inverted eight Glyph connection structure.
- each wave trough is connected to a first flexible connecting member, and part of the wave peak is connected to the first flexible connecting member.
- the first flexible connecting member is continuously connected with at least the second flexible connecting member adjacent to a row connecting the supporting unit.
- the first flexible connecting member connecting the two adjacent support units in the axial direction and the second flexible connecting member on one of the supporting units are continuously connected.
- first flexible connecting member connecting two axially adjacent ring supporting frames and the second flexible connecting member on one of the ring supporting frames are integrated structures.
- the first flexible connecting member and the second flexible connecting member in at least two adjacent rows in the axial direction are an integrated structure from the proximal end to the distal end.
- the second flexible connecting member is spirally wound on the supporting unit in sequence with a space between each turn.
- the spiral winding is preferably clockwise winding or counterclockwise winding.
- the support unit includes a winding support unit wound by the second flexible connector, a bare support unit not wound by the second flexible connector, a winding support unit, and a bare support unit.
- the support units are arranged alternately.
- the winding support unit and the bare support unit are arranged alternately and repeatedly.
- the winding support unit and the bare support unit of different turns are arranged alternately and repeatedly in a row in the axial direction.
- the winding support unit is a fully-wound support unit in which the crests, waves, and troughs of a support unit are all wound by a flexible connector;
- the winding support unit is a semi-winding support unit in which a supporting unit is wound from a wave crest to a wave pole, or from a wave trough to a wave pole.
- the first flexible connecting member and the second flexible connecting member are respectively a linear structure, a strip structure or a band structure.
- the annular support frame is preferably a high-wave support composed of a high-wave support unit and a low-wave support unit, and the peaks of the low-wave support unit are connected to the first flexible connector and the high-wave support unit.
- the wave crest is not connected to the first flexible connector.
- the first flexible connecting member is preferably connected in a knot or a winding manner between peaks and troughs of the support units of different circles.
- the stent further includes a tubular covering film, and the annular support frame is arranged axially and sequentially on the inner surface or / and the outer surface of the covering film.
- the ring-shaped support frame is a high-low wave support composed of a high-wave support unit and a low-wave support unit, and the high-low wave support is fixed on the outer surface or the inner surface of the film, and the low-wave support
- the support unit is fixed to the pellicle, and the peaks of the high-wave support unit are not fixed to the pellicle.
- the covering film includes an inner covering film and an outer covering film, and the annular support frame is disposed between the inner covering film and the outer covering film.
- the invention provides a bracket, a plurality of annular support frames arranged in an axial direction, and the wave peaks and troughs of a plurality of support units of different circle annular support frames are connected by a first flexible connecting piece, and the first flexible connecting piece It is also extended to be wound onto at least one support unit to form a second flexible connection. Due to the connection through the first flexible connector and the second flexible connector, the stent is easy to bend after expansion, and has good compliance. The entire stent has good compressibility, transport flexibility and uniform expansion.
- FIG. 1 is a schematic diagram of a stent deployment structure according to a first embodiment of the present invention
- FIG. 2 is a schematic structural diagram of a ring-shaped support frame according to an embodiment of the present invention.
- FIG. 3 is a schematic structural diagram of a bracket according to a first embodiment of the present invention.
- FIG. 4 is a partially enlarged view at I in FIG. 1; FIG.
- FIG. 5 is a schematic structural diagram of a bracket according to a second embodiment of the present invention.
- FIG. 6 is a schematic structural diagram of a bracket according to a third embodiment of the present invention.
- FIG. 7 is a schematic structural diagram of a bracket according to a fourth embodiment of the present invention.
- FIG. 8 is a schematic structural diagram of a fifth bracket according to an embodiment of the present invention.
- FIG. 9 is a schematic structural diagram of a bracket according to a sixth embodiment of the present invention.
- FIG. 10 is a partially enlarged view of Embodiment 6 of the present invention.
- proximal end in the present invention refers to a portion of a stent or stent component that is close to a patient's heart along the blood flow direction
- distal end refers to a portion of the stent or stent component that is far from the patient's heart.
- a high-flexibility stent includes a plurality of annular support frames 100 arranged in an axial direction.
- the annular support frame 100 is formed by a plurality of wave-shaped support units 110 connected end to end.
- the support unit 110 includes a wave peak 111, a wave valley 113, The wave poles 112 connected between the wave peaks 111 and the wave valleys 113.
- the wave peaks 111 and the wave valleys 113 of the support units 110 in different turns are connected through the first flexible connecting member 210,
- the first flexible connecting member 210 is further extended to be wound onto at least one supporting unit 110 to form a second flexible connecting member 220.
- the stent of this embodiment is a bare stent without a film.
- the ring-shaped support frames 100 of two adjacent circles pass through a plurality of first flexible connecting members 210. Connected to form a stent with a tubular structure.
- the number of the ring-shaped support frames 100 is 16 turns
- the number of the first flexible connecting members 210 is 15 turns
- the interval between the two adjacent ring-shaped support frames 100 is between 0.3 and 0.5 mm.
- the bracket is a closed-loop structure and an open-loop structure which are arranged at intervals.
- the closed-loop structure refers to the wave crests of a part of the support unit 110 of the annular support frame 100 and the axially adjacent annular support frame 100 through the first flexible connection member 210.
- the troughs are connected to form a closed diamond-shaped structural unit;
- the open-loop structure refers to the crests or troughs of a part of the supporting unit 110 of the annular supporting frame 100 are not connected to the axially adjacent annular supporting frame 100 through the first flexible connecting member 210, so
- the unconnected crests or troughs are not restricted, and the crests of the unbounded open-loop structure when the stent is bent can perform adaptive activities as the stent is bent.
- the annular support frame 100 is the main part of the entire vascular stent.
- Each annular support frame 100 is a ring structure and is formed by supporting units 110 end to end.
- the supporting unit 110 includes a wave peak 111 and a wave valley 113. Between the crest 111 and the trough 113 is a wave pole 112.
- the ring-shaped support frame 100 includes all support units 110 which are the same height wave support frames with the same wave height, or the support units 110 are high and low wave support frames with different wave heights. In the same blood vessel stent, it may include only one type.
- the type of ring-shaped support frame 100 may also include two types of brackets formed by mixing together. This embodiment is a contour wave support frame.
- the ring-shaped support frame 100 of this embodiment is composed of multiple Z-shaped or sinusoidal contour wave support frames.
- Each Z-shaped or sine-wave support unit 110 has a peak 111 and an adjacent valley 113, and the peak 111 and There is a wave pole 112 between the adjacent wave valleys 113.
- Each ring support frame 100 is made of a super-elastic nickel-titanium wire.
- the diameter of the nickel-titanium wire is thin, and can be between 0.15 and 0.3 mm. In this first embodiment, a nickel-titanium wire with a diameter of 0.2 mm is woven.
- the number of Z-shaped or sine-wave supporting units 110 is eight, and the wave height of the ring-shaped supporting frame 100 is 5.5 mm.
- the stent of the present invention may be an equal-diameter stent with the same diameter of the ring-shaped support frame 100 per circle, or a non-equal-diameter stent with different diameters of the ring-shaped support frame 100.
- the structure and connection method of the flexible connector 200 in the non-equal-diameter bracket and the equal-diameter bracket are the same.
- This embodiment takes the equal-diameter bracket as an example for detailed description:
- the support unit 110 is divided into two cases. One is that the wavelength of the support unit 110 in different circles in the axial direction is the same. In the ring-shaped support frame 100 in different circles in the axial direction, the support unit 110 can correspond to the axial direction. Arrangement, that is, the axially adjacent peaks correspond to the crests, the troughs and the troughs, and can also be staggered, that is, the two adjacent support units 110 in the axial direction are staggered with each other at a certain distance, for example, the crest 111 of one support unit 110 Corresponding to the wave rod 112 of the other supporting unit 110 in the axial direction, a spiral arrangement is formed.
- the wavelengths of the supporting units 110 in different circles in the axial direction are the same, and the axially adjacent peaks and crests, the troughs and the troughs are arranged in a row corresponding to each other.
- the first flexible connecting member 210 is connected between the wave peaks 111 and the wave valleys 113 of the two supporting units 110 in different columns in the axial direction.
- the wavelengths of the support units 110 in different circles in the axial direction are different. It can also make the support units 110 in the annular support frame 100 in different circles in the axial direction correspondingly arranged, for example, one support unit 110 per circle. The two or more supporting units 110 corresponding to another circle may also be arranged alternately.
- the flexible fingers of the first flexible connecting member 210 and the second flexible connecting member 220 can be arbitrarily bent and twisted, and cannot be stretched or slightly stretched in the axial direction.
- the first flexible connecting member 210 and the second flexible connecting member 210 are preferred.
- Each of the flexible connecting members 220 is a linear structure, a strip structure, or a band structure. It may also be preferred that the first flexible connecting member 210 and the second flexible connecting member 220 are a linear structure, a strip structure, or a strip that is continuously wound axially between a plurality of wave peaks 111 and wave troughs 113 and different support units 110. ⁇ ⁇ Like structure. Among linear structures, strip structures, or band structures, linear structures are preferred.
- the first flexible connecting member 210 is connected between the wave peaks 111 and the wave troughs 113 of the two adjacent support units 110 in the axial direction.
- the first flexible connecting member 210 is specifically the wave trough 113 and the phase at the far end of one supporting unit 110.
- the crests 111 at the proximal end of the closest support unit 110 in the adjacent column of the adjacent circle are connected.
- the connection method may be a knot connection or a winding connection.
- the knotting method is that the two ends of the first flexible connecting member 210 are knotted and fixed on the wave trough 113 and the wave peak 111, respectively.
- the winding method is that the first flexible connecting member 210 is wound on the trough 113 and the crest 111.
- the length of the first flexible connecting member 210 between the wave peak 111 and the wave valley 113 is determined as required.
- the first flexible connecting member 210 and the second flexible connecting member 220 may be independently provided, that is, the two ends of the first flexible connecting member 210 are wound or knotted and fixed on the wave peak 111 and the wave valley 113. The two ends are wound or knotted and fixed on the support unit 110.
- the first flexible connecting member 210 and the second flexible connecting member 220 may also be continuously disposed, and it is preferable that the first flexible connecting member 210 and the second flexible connecting member 220 are connected together or an integrated structure.
- the integral structure connection is also divided into two cases: one is that the first flexible connector 210 between a pair of wave peaks 111 and valleys 113 and the second flexible connector 220 of the same support unit 110 are an integrated structure, and the other is the first A flexible connecting piece 210 and a second flexible connecting piece 220 are continuously wound in the axial direction between a plurality of wave peaks 111 and wave troughs 113 and on different support units 110, and it is particularly preferable to connect two adjacent support units in the axial direction.
- the first flexible connecting member 210 of 100 and the second flexible connecting member 220 wound around one of the rings are an integrated structure.
- the first flexible connecting member 210 is continuously connected with at least the second flexible connecting member 220 wound around its adjacent circle and one of the two adjacent rows of support units, and the continuous connection refers to the first A flexible connecting piece 210 and the second flexible connecting piece 220 are an integrated structure, or the first flexible connecting piece 210 and the second flexible connecting piece are connected together by a knot or other means.
- the pulling force of each other pulls the first flexible connector 210 connecting the two axial support units 100 through continuous winding of the second flexible connector 220 to the adjacent rows of support units, which can further strengthen the continuous structure of the overall support structure. Sex and stability.
- the first flexible connecting member 210 connecting two axially adjacent ring supporting frames and the second flexible connecting member 220 on one of the ring supporting frames are integrally connected in a line shape, a strip shape, or Ribbon structure.
- the first flexible connecting member 210 between a pair of wave peaks 111 and 113 can be fixed by winding or knotting the length of the first flexible connecting member 210 between the wave peaks 111 and 113, respectively.
- the present invention is not limited, and it is preferable to connect and maintain the plurality of support units 110 in the axial direction correspondingly without twisting or radial offset, and keeping the overall stent in a cylindrical structure.
- the second flexible connecting member 220 provided on the support unit 110 wave rod 112 wave rod 112
- the winding length there are various embodiments, which can be divided into a fully wound support unit and a semi-wound support unit, wherein the fully wound support unit is the entire support unit 110 are all wound with the second flexible connecting member 220, and the semi-wound support unit is only partially wound with the second flexible connecting member 220.
- the winding support unit 101 is preferably a fully-wound support unit in which the second flexible connector 220 winds up the crests 111, the wave rods 112, and the trough 113 of one support unit 110; or the winding support unit 101 may be the first The two flexible connecting members 220 wind one support unit 110 from the wave peak 111 to the wave pole 112, or the wave valley 113 to the semi-wound support unit 112.
- the second flexible connecting members 220 on the winding support unit 101 are sequentially spirally wound on the support unit 110 with a space between each turn.
- the spiral winding is a clockwise winding or a counterclockwise winding.
- the arrangement of the winding support unit 101 has the advantage that the arrangement of the winding support unit 101 can connect two axially adjacent support frames 100 through a continuous first flexible connection member 210 and a second flexible connection member 220 into one. Overall, at the same time, it is possible to cross part of the wave crest 111 by winding, so that part of the wave crest 111 is not bound to the first flexible connecting member 210, so that the stent as a whole includes a part of the freely movable bare stent unit 102, while ensuring that the stent Stability and suppleness.
- the continuous winding and fixing can ensure the continuity between the axially adjacent two rings of the annular support frame 100, thereby ensuring the continuity of the entire support, enhancing the radial support strength of the support and the stability of the overall connection of the support.
- the first flexible connecting members 210 in the same circle are connected in the same direction. That is, the crests 111 in a circle of the ring-shaped supporting frame 100 are only connected to the adjacent valleys 113 on the left or only to the adjacent valleys 113 on the right; the first flexible connector 210 in the same circle can also be connected in a different direction.
- the peaks 111 in a circle of the ring-shaped support frame 100 may be connected to the left or right adjacent valleys 113; or the first flexible connector 210 may be simultaneously connected to the peaks 111 and phases of one support unit 110 at the same time.
- the valleys 113 of the two adjacent rows of support units 110 in the adjacent circle are connected to form an inverted sigma-shaped connection structure. This connection structure can make the connection more stable and prevent the formation between the adjacent two circle ring support frames 100. Twist and offset.
- the supporting unit 110 Since a part of the supporting unit 110 is wound with the second flexible connecting member 220, the supporting unit 110 includes a winding supporting unit 101 wound by the second flexible connecting member 220, and a bare supporting unit not wound by the second flexible connecting member 220. 102; the winding support unit 101 and the bare support unit 102 are alternately arranged, and then there are various ways of arranging the support unit 110: in the same ring support frame 100, the winding support unit 101 and the bare support unit 102 are alternately arranged one by one ring. In the axial direction, the winding support units 101 and the bare support units 102 of different turns are alternately arranged in a row.
- the alternation herein means that the winding support unit 101 and the bare support unit 102 are repeatedly arranged according to a certain rule. That is, in the same circle of the ring-shaped support frame 100, the winding support unit 101 and the bare support unit 102 are alternately arranged in a circle according to a certain arrangement rule.
- the arrangement rule refers to the alternation between the winding support unit 101 and the bare support unit 102.
- the rule can be repeated arrangement of 1-4 winding support units 101 and 1-4 bare support units 102, for example: one winding support unit 101 and one bare support unit 102 alternate, one winding support unit 101 and two The bare support units 102 are alternated, two winding support units 101 and one bare support unit 102 are alternated, and the like.
- the arrangement rules are determined according to the actual requirements of the support compliance, support force and other conditions, which are not limited in the present invention.
- each wave trough 113 is connected to the first flexible connecting member 210, and some of the wave crests 111 are connected to the first flexible connecting member 210. Then, the arrangement of the first flexible connecting members 210 makes the same circle of the wave support frame. In 100, the winding support unit 101 and the bare support unit 102 are alternately arranged at intervals.
- the arrangement of the support units 110 between different circles also follows an alternating rule: the winding support units 101 and the bare support units 102 of different circles are alternately and repeatedly arranged in a row according to the arrangement rule.
- an alternating rule can be arbitrarily set, and it is possible to repeat the arrangement by combining 1-4 winding support units 101 and 1-4 bare support units in the axial direction.
- one winding support unit 101 and one bare support unit 102 alternate, one winding support unit 101 and two bare support units 102 alternate, two winding support units 101 and one bare support unit 102 alternate, and so on.
- the non-corresponding support units 110 may also be shifted in the circumferential direction by a certain distance according to the above-mentioned alternating rules to form a spiral alternate arrangement.
- the ring-shaped supporting frame 100 is axially connected through the first flexible connecting member 210 and the second flexible connecting member 220, and the first flexible connecting member 210 and the second flexible connecting member 220 are integrated.
- the second flexible connecting member 220 is wound clockwise along the wave rod 112 and the wave peak 111 to the next valley 113 by winding from the trough 113 of the annular support frame 100, and then the first The flexible connecting member 210 is wound downwardly through the adjacent wave peak 111 of the second ring-shaped support frame 100, and then upwards, and the second flexible connecting member 220 is wound around the wave trough 113 of the first ring-shaped support frame 100.
- the first flexible connecting member 210 is wound around each crest 111 on the ring-shaped supporting frame 100, and the first flexible connecting member 210 and the second flexible connecting member 220 return to the starting position on the ring-shaped supporting frame 100 after one circle. 113 previous trough.
- the winding on the second ring support frame 100 starts from a position of a trough 113 relative to the winding position of the first ring support frame 100, and the winding method is the same as the winding method of the first ring until the penultimate turn on the far end.
- the first flexible connecting member 210 and the second flexible connecting member 220 are formed as a whole structure by winding each turn.
- the first flexible connecting member 210 and the second flexible connecting member 220 used in the present invention adopt a linear structure of a polymer material or a metal material.
- PET wire, PP wire, PTFE wire with a diameter between 0.02 and 0.05 mm
- this example uses a PTFE wire with a diameter of 0.03 mm, or a thinner memory alloy wire such as a nickel-titanium alloy wire, Or a thinner multi-filament combination, which may be a combination between polymer materials, a combination of metal materials, or a combination of polymer materials and metal materials.
- the ring-shaped support frame at the far end is a bare support unit 102 except that a part of the peak is connected with the first flexible connector 210, and the support unit itself does not extend the second flexible connector 220.
- the first flexible connecting member 210 and the second flexible connecting member 220 are wrapped on the ring-shaped support frame 100 in a winding manner.
- the trough 113 winds down the crest 111 of the next ring support frame 100, and then goes back up to the trough 113 position of the previous ring support frame 100.
- the number of windings at the peak 111 and trough 113 positions is 2-4.
- knots are fixed at the peaks 111 and 113.
- the troughs 113 of the two adjacent ring support frames 100 in the axial direction are located on the same axis, that is, the troughs 113 of the two adjacent ring support frames 100 in the axial direction correspond to the wave peak 111 in the axial direction, and
- the crest 111 of the ring-shaped supporting frame 100 is opposite to the crest 111.
- the first flexible connecting member 210 is wound and connected to the adjacent two circles of the ring supporting frame 100 at an interval of the crest 111, forming a stable between the adjacent two circles of the ring supporting frame 100.
- stable closed-loop structure can ensure the overall radial and axial stability of the stent, and also includes several unsupported wave crests 111 of the bare support unit 102, which can ensure a certain space for the ring-shaped support frame 100 to strengthen The compliance of the bracket; on the other hand, the two adjacent ring-shaped support frames 100 are connected through the first flexible connecting member 210 and the second flexible connecting member 220, which is beneficial to improving the bending flexibility of the bracket.
- This embodiment is an improvement based on the first embodiment.
- the ring-shaped support frame 100 is a contour wave support, which is composed of a multi-turn ring-shaped support frame 100 and a plurality of turns of a first flexible connecting member 210 and a second flexible connecting member 220.
- the difference between this embodiment and the first embodiment lies in that the alternating regularity of the winding support unit 101 and the bare support unit 102 is different from that of the first embodiment.
- two winding support units 101 and a bare support unit form an alternating pattern, arranged in a circle; in the axial direction, two winding support units 101 and a bare support unit form an alternating pattern.
- the first flexible connecting member 210 and the second flexible connecting member 220 are continuously wound around the two supporting units 110 and spaced one supporting unit 110, and then are wound again, that is, one wave peak 111 is connected to two similar wave troughs 113, and two wave peaks 111 are not spaced in the middle. Constrained by the first flexible connecting member 210, the number of unbound wave peaks 111 is greater than that of the first embodiment, which further enhances the compliance of the stent.
- the ring-shaped support frame 100 on the near first end is wound from the trough 113 of the starting position to the second flexible connecting member 220 to form a fully-wound support unit, and then to the trough 113, two consecutive winding clockwise
- the first flexible connector 210 is wound downward at the trough 113 position, passes through the peak 111 position of the second annular support frame 100, and then is wound up at the trough 113 spaced one wave peak 111 back to the first circle of the support support 100.
- the unit 110 continues to be wound clockwise in this manner back to the trough 113 position of the starting position, and is tied and fixed.
- the second circle of the ring-shaped supporting frame 100 is wound from the position of the next wave trough 113 which is wound relative to the starting position of the first circle of the ring-shaped supporting frame 100.
- This embodiment is an improvement based on the first embodiment.
- the difference between the third embodiment and the first embodiment of the present invention lies in that there are two types of ring-shaped support frames 100, a constant-wave support frame and a high-low wave support frame.
- the first lap at the near end is a support frame of constant height waves, and the rest are support frames of high and low waves.
- the high-low wave support frame is composed of a high-wave support unit and a low-wave support unit alternately. Understandably, in other embodiments, two or more high-wave support units and one low-wave support unit may be alternated, or one high-wave support unit and two or more low-wave support units may be alternated, or two or Multiple high-wave support units and two or more low-wave support units alternate.
- the first-round annular support frame 100 is a constant-wave support frame, and the high- and low-wave support frames are arranged axially from the second-circle ring support frame 100.
- the height difference between the high-wave support unit and the low-wave support unit is between 0.5 and 1 mm.
- the ring-shaped support frame 100 is a high-wave support bracket composed of a high-wave support unit and a low-wave support unit.
- the peak 111 of the low-wave support unit is connected to the first flexible connector 210, and the peak 111 of the high-wave support unit is not connected to the first flexible connector. 210.
- the winding of the second flexible connecting member 220 is wound from the wave trough 113 at the starting position of the first-round annular support frame 100, and is continuously wound clockwise through the wave rod 112 and the wave peak 111, and the first wave is downwardly flexible at the next wave valley 113.
- the connecting member 210 is wound around the crest 111 of the low-wave support unit 110 of the second ring supporting frame 100, and the first flexible connecting member 210 is wound up again to the wave trough 113 of the first ring supporting frame 100, which is wound clockwise to the starting position.
- the previous trough 113 was knotted and fixed.
- the second flexible support member 220 is wound on the second ring support frame 100 from a position of a trough 113 relative to the winding position of the first ring support frame 100.
- the winding method is the same as that in the first embodiment.
- the ring-shaped support frame 100 is staggered with the high-wave support unit 110 and the low-wave support unit 110, which increases the bending angle of the ring-shaped support frame 100 and improves compliance.
- This embodiment is an improvement based on the first embodiment.
- the difference between this embodiment and the first embodiment is that the alternation pattern of the winding support unit 101 and the bare support unit 102 is different from that of the first embodiment.
- the two winding support units 101 alternate with a bare support unit 102, then alternately with a winding support unit 101, and finally with a bare support unit 102.
- the two winding support units 101 are alternated to form an alternating pattern.
- the adjacent second column is the two winding support units 101. 102 forms an alternating pattern.
- the third column is a bare support unit 102 that alternates two winding support units 101 to form an alternating pattern; the fourth column is the same as the first column, except that the first column is a bare winding support unit 102, and the rest is a winding
- the supporting unit 101 alternates with two bare supporting units 102; the sixth column is the same as the first column, and the seventh column is the same as the second column, and is arranged in this way.
- the first flexible connecting member 210 connects one wave peak 111 to two similar wave troughs 113, and one or two wave peaks 111 in the middle are not bound by the flexible connecting member 200. That is, in the ring-shaped supporting frame 100 in the same circle, each of the wave troughs 113 is connected to the first flexible connecting member 210, and part of the wave crests 111 are connected to the first flexible connecting member 210.
- the ring-shaped supporting frame 100 on the near first end is wound around the flexible connector 200 from the position of the trough 113, and is continuously wound clockwise across the two crests 111, and is wound down on the second trough 113.
- the crest 111 of the second circle of the ring support 100 is wound up again to the wave trough 113 of the first circle of the ring support 100, and then a wave of the ring support 100 is clockwise wound, and the second circle of the bracket 111 is wound downward at the trough 113, and then Wind up the wave trough 113 of the ring-shaped support frame 100 for the first circle, and then wind it back to the wave trough 113 at the starting position clockwise, and tie and fix it.
- the flexible support 200 is wound on the second ring support frame 100 from a position of a trough 113 relative to the winding position of the first ring support frame 100 in the same manner as the first ring.
- the number of unconstrained wave peaks 111 and wave troughs 113 is greater than that of the first embodiment, which further enhances the compliance of the stent.
- This embodiment is an improvement based on the first embodiment.
- the stent in addition to the bare stent composed of the ring-shaped support frame 100, the stent further includes a tubular cover film 300, and the ring-shaped support frame 100 is sequentially arranged axially and fixed to the cover film. 300 inner or / and outer surface.
- This embodiment is a two-layer film 300, which includes an inner layer film 301 and an outer layer film 302. The two tubular films 300 are set together to form an inner layer film 301 and an outer layer film 302. .
- the annular support frame 100 is disposed between the inner layer film 301 and the outer layer film 302.
- the inner layer covering film 301 is a tubular integrated structure, which is located in the inner layer of the stent and is used to support the role of the tubular structure of the entire stent.
- the outer cover film 302 is a tubular integrated structure, which is located at the outermost layer of the stent, and covers the outer surfaces of the annular support frame 100 and the first flexible connecting member 210 and the second flexible connecting member 220.
- the ring-shaped support frame 100, the first flexible connecting member 210, and the second flexible connecting member 220 are sandwiched between the inner layer coating film 300 and the outer layer coating film 300, so that the overall structure of the stent can be maintained.
- the inner layer film 301 and the outer layer film 302 may be integrated by a heat sealing method.
- the material of the film 300 is a polymer film such as PET or ePTFE, and the inner layer film 301 and the outer layer film 302 can be compounded by using 1-5 polymer films, for example, 3 films each. Structural composite formation.
- first flexible connecting member 210 and the second flexible connecting member 220 are made of a polymer wire such as a PET wire, a PP wire, or a PTFE
- the first flexible connection wound on a support frame after hot pressing The member 210 and the second flexible connecting member 220 can be better fused with the polymer film, and the overall structure of the stent graft is more stable.
- the structures of the annular support frame 100, the first flexible connecting member 210, and the second flexible connecting member 220 are the same as those in the first embodiment, and details are not described herein again.
- This embodiment is an improvement based on the third embodiment.
- a cover film 300 is provided inside and outside the bare stent of the third embodiment.
- the ring-shaped support frame 100 is a high-wave support bracket composed of a high-wave support unit and a low-wave support unit.
- the high-low wave support is fixed on the inner surface or the outer surface of the coating 300.
- the low-wave support unit is fixed to the coating 300, and the high-wave support
- the peak 111 of the cell 110 and the cover film 300 are not fixed.
- the bracket includes a ring-shaped supporting frame 100, the first flexible connecting member 210 and the second flexible connecting member 220, an inner layer coating 301 and an outer layer coating 302; the ring-shaped supporting frame 100, the first flexible The connecting member 210 and the second flexible connecting member 220 are located in the middle layer of the stent, between the inner layer film 301 and the outer layer film 302.
- the difference between this embodiment and the fifth embodiment is that the structure of the bare stent is a high and low wave structure, and the high wave peak 111 is not covered by the outer film 302.
- the inner cover film 301 is a tubular integrated structure and is located inside the annular support frame 100.
- the outer cover film 302 is a multilayer ring structure arranged axially at intervals. Each turn of the outer cover film 302 is wrapped from the short crest 111 of the ring support frame 100 to the next ring support frame 100. Up to the trough 113, the peak 111 of the high wave is exposed. When the stent is bent, the unconstrained wave peak 111 does not restrict the bending movement of the stent graft. Therefore, the stent 300 method in this embodiment improves the axial compliance of the stent.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Optics & Photonics (AREA)
- Physics & Mathematics (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
本发明公开了一种高柔顺性支架,包括轴向排列的多个环形支撑架,所述环形支撑架由多个波形的支撑单元首尾相接形成,所述支撑单元包括波峰、波谷、连接在波峰和波谷之间的波杆,相邻两圈环形支撑架中,多个不同圈支撑单元的波峰和波谷之间通过第一柔性连接件连接,且所述第一柔性连接件还延伸缠绕到至少一个支撑单元上形成第二柔性连接件。本发明提供一种具有良好的可压缩性、输送柔顺性和扩张均匀性的高柔顺性支架。
Description
本发明属于医疗器械技术领域,具体涉及一种支架,尤其涉及一种可用于腔内介入治疗的高柔顺性支架。
外周血管疾病是全身动脉粥样硬化的一种常见表现,其发病率近年有明显上升,常见的如动脉硬化性闭塞症、动静脉血栓形成、动脉瘤等。可诱发全身动脉硬化和心血管发病率和死亡率。外周血管发生病变后,血管腔变狭窄,注入下肢的血流量变小,引起下肢供血不足,造成肢体坏死等现象。
外周血管疾病主要治疗方法包括内科治疗和手术治疗,其中内科治疗:降压、降脂,抗血小板聚集等治疗可延缓下肢动脉硬化闭塞的病程进展,但不能从根本上消除血管的狭窄、闭塞等器质性病变。手术治疗:分为开放手术和血管腔内介入治疗。血管腔内介入治疗:具有微创、操作简单、疗效确切、可重复操作的优点,是诊治血管性疾病的发展方向。
主动脉瘤是指主动脉壁局部或弥漫性的异常扩张,压迫周围器官而引起症状,瘤状破裂为其主要危险。常发生在升主动脉、主动脉弓、降主动脉、胸腹主动脉和腹主动脉。主动脉瘤按结构可分为真性主动脉瘤、假性主动脉瘤和夹层主动脉瘤。主动脉瘤引起血管内侧压增高,故呈进行性膨大,若长期发展,最后终归破裂,瘤体越大,破裂的可能性越大。据统计,若不作手术治疗,90%胸主动脉瘤在5年内死亡,3/4腹主动脉瘤在5年内死亡。
胸主动脉腔内修复术治疗范围包括主动脉夹层、主动脉穿通性溃疡、主动脉壁间血肿、胸主动脉瘤及假性动脉瘤等多种主动脉扩张性病变,以及主动脉外科术后或TEVAR术后并发症的二次腔内治疗。另一方面,自20世纪90年代报道首例采用腹主动脉腔内修复术治疗腹主动脉瘤以来,EVAR在全世界范围内迅速推广开来,EVAR因其创伤小、手术及住院时间短、术后恢复快、手术期病死率及并发症发生率低等优点,在短短的20年内迅速发展,已成为当前腹主动脉瘤首选的治疗方法。
目前应用较多的介入治疗器械主要包括球囊扩张支架和自扩张支架。自扩张支架是目前在血管介入治疗中应用较多的支架,自扩张支架中,常用有闭环支架,即支架的轴向相邻的两个支撑单元之间的波峰与波谷都通过连接杆连接,闭环支架的优点是金属覆盖率较大,且具有较大的径向支撑力,可均匀覆盖在血管壁上,防止斑块脱落,但这种设计柔顺性相对较差,不能适应弯曲复杂病变血管。由于在血管支架的应用过程中,需要对血管支架进行压缩、输送和扩张,所以血管支架必须具有良好的可压缩性、输送柔顺性和扩张均匀性,这对血管支架的材料和结构设计提出了非常高的要求,现有支架尚不能很好的实现这些技术指标的完美统一。
发明内容
本发明要解决的技术问题在于,针对现有技术的缺陷,提供一种具有良好的可压缩性、输送柔顺性和扩张均匀性的高柔顺性支架。
本发明解决其技术问题所采用的技术方案是:
一种高柔顺性支架,包括轴向排列的多个环形支撑架,所述环形支撑架由多个波形的支撑单元首尾相接形成,所述支撑单元包括波峰、波谷、连接在波峰和波谷之间的波杆,相邻两圈环形支撑架中,多个不同圈支撑单元的波峰和波谷之间通过第一柔性连接件连接,且所述第一柔性连接件还延伸缠绕到至少一个支撑单元上形成第二柔性连接件。
进一步地,所述的高柔顺性支架中,优选在轴向上不同圈的支撑单元的波长相同,且轴向上一一对应成列排布,相邻两圈环形支撑架中,所述第一柔性连接件连接在轴向不同列的两个支撑单元的波峰和波谷之间。
进一步地,所述的高柔顺性支架中,优选所述第一柔性连接件同时在一个支撑单元的波峰与相邻圈中两个相邻列的支撑单元的波谷之间连接,以形成倒八字形的连接结构。
进一步地,所述的高柔顺性支架中,优选同一圈环形支撑架中,每一个波谷上均连接第一柔性连接件,部分波峰上连接第一柔性连接件。
进一步地,所述的高柔顺性支架中,优选所述第一柔性连接件至少与其连接支撑单元相邻列的第二柔性连接件连续连接。
进一步地,所述的高柔顺性支架中,优选连接轴向相邻两圈支撑单元的第一柔性连接件和其中一圈支撑单元上的第二柔性连接件是连续连接的。
进一步地,所述的高柔顺性支架中,优选连接轴向相邻两圈环形支撑架的第一柔性连接件和其中一圈环形支撑架上的第二柔性连接件是一体结构。
进一步地,所述的高柔顺性支架中,优选轴向上,至少相邻两列的第一柔性连接件和第二柔性连接件是从近端到远端的一体结构。
进一步地,所述的高柔顺性支架中,优选所述第二柔性连接件顺序螺旋缠绕在支撑单元上并且每圈之间留有间距。
进一步地,所述的高柔顺性支架中,优选所述螺旋缠绕为顺时针缠绕或逆时针缠绕。
进一步地,所述的高柔顺性支架中,优选所述支撑单元包括被所述第二柔性连接件缠绕的缠绕支撑单元,未被第二柔性连接件缠绕的裸支撑单元,缠绕支撑单元和裸支撑单元交替设置。
进一步地,所述的高柔顺性支架中,优选同一圈环形支撑架中,缠绕支撑单元和裸支撑单元交替重复排布一圈。
进一步地,所述的高柔顺性支架中,优选在轴向上,不同圈的缠绕支撑单元和裸支撑单元交替重复排布一列。
进一步地,所述的高柔顺性支架中,优选所述缠绕支撑单元为柔性连接件将一个支撑单元的波峰、波杆和波谷全部缠绕的全缠绕支撑单元;
或者所述缠绕支撑单元为柔性连接件将一个支撑单元由波峰缠绕至波杆、或者由波谷缠绕至波杆的半缠绕支撑单元。
进一步地,所述的高柔顺性支架中,优选所述第一柔性连接件和第二柔性连接件分别各自为线状结构、条状结构或带状结构。
进一步地,所述的高柔顺性支架中,优选所述环形支撑架为高波支撑单元和低波支撑单元组成的高低波支架,其低波支撑单元的波峰连接第一柔性连接件、高波支撑单元的波 峰不连接第一柔性连接件。
进一步地,所述的高柔顺性支架中,优选所述第一柔性连接件在不同圈支撑单元的波峰和波谷之间通过打结或缠绕方式连接。
进一步地,所述的高柔顺性支架中,优选所述支架还包括管状的覆膜,所述环形支撑架轴向顺次排布并固定在所述覆膜内表面或/和外表面。
进一步地,所述的高柔顺性支架中,优选所述环形支撑架为高波支撑单元和低波支撑单元组成的高低波支架,所述高低波支架固定在覆膜外表面或内表面,低波支撑单元与覆膜固定,高波支撑单元的波峰与覆膜之间不固定。
进一步地,所述的高柔顺性支架中,优选所述覆膜包括内层覆膜和外层覆膜,所述环形支撑架设置在内层覆膜和外层覆膜之间。
本发明提供了一种支架,轴向排列的多个环形支撑架,多个不同圈环形支撑架的支撑单元的波峰和波谷之间通过第一柔性连接件连接,且所述第一柔性连接件还延伸缠绕到至少一个支撑单元上形成第二柔性连接件。由于通过第一柔性连接件和第二柔性连接件的连接,则支架在扩张后易弯曲,顺应性好,整个支架具有良好的可压缩性、输送柔顺性和扩张均匀性。
下面将结合附图及实施例对本发明作进一步说明,附图中:
图1是本发明实施例一支架展开结构示意图;
图2是本发明实施例一环形支撑架的结构示意图;
图3是本发明实施例一支架的结构示意图;
图4是图1中I处局部放大图;
图5是本发明实施例二支架的结构示意图;
图6是本发明实施例三支架的结构示意图;
图7是本发明实施例四支架的结构示意图;
图8是本发明实施例五支架的结构示意图;
图9是本发明实施例六支架的结构示意图;
图10是本发明实施例六的局部放大图。
为了对本发明的技术特征、目的和效果有更加清楚的理解,现对照附图详细说明本发明的具体实施方式。
本发明所述“近端”是指沿血流方向,靠近患者心脏的支架或支架部件的部分,而所述“远端”是指远离患者心脏的支架或支架部件的部分。
实施例一
一种高柔顺性支架,包括轴向排列的多个环形支撑架100,所述环形支撑架100由多个波形的支撑单元110首尾相接形成,所述支撑单元110包括波峰111、波谷113、连接在波峰111和波谷113之间的波杆112,相邻两圈环形支撑架100中,多个不同圈支撑单元110的波峰111和波谷113之间通过第一柔性连接件210连接,且所述第一柔性连接件210 还延伸缠绕到至少一个支撑单元110上形成第二柔性连接件220。
本实施例的支架为没有覆膜的裸支架,有多圈环形支撑架100从近端到远端依次平行间隔排布,相邻两圈的环形支撑架100通过多个第一柔性连接件210连接,形成筒状结构的支架。本实施例一中环形支撑架100的数量为16圈,第一柔性连接件210的数量为15圈,相邻两圈环形支撑架100的间隔在0.3~0.5mm之间。
优选所述支架为相互间隔设置的闭环结构和开环结构,所述闭环结构是指环形支撑架100的部分支撑单元110通过第一柔性连接件210与轴向相邻的环形支撑架100的波峰或波谷相连形成封闭的菱形结构单元;开环结构是指环形支撑架100的部分支撑单元110的波峰或者波谷未通过第一柔性连接件210与轴向相邻的环形支撑架100相连接,所述未连接的波峰或者波谷没有被限制,支架弯折时未束缚的开环结构的波峰可随支架弯曲做适应性的活动。
如图2所示,环形支撑架100是整个血管支架的主体部分,每个环形支撑架100都是一个环形结构,由支撑单元110首尾相接形成,支撑单元110包括波峰111和波谷113,在波峰111和波谷113之间为波杆112。从波高上讲,所述环形支撑架100包括所有支撑单元110为波高相同的等高波支撑架、或者支撑单元110为波高不同的高低波支撑架,在同一个血管支架中,可以只包括一种类型的环形支撑架100,也可以同时包括两种混合在一起形成的支架,本实施例为等高波支撑架。本实施例的环形支撑架100由多个Z形或正弦组成的等高波支撑架,每个Z形或正弦波的支撑单元110有1个波峰111和1个相邻的波谷113,波峰111和相邻的波谷113之间有1条波杆112。每圈环形支撑架100采用一条超弹性镍钛丝编织而成,镍钛丝丝径较细,可在0.15~0.3mm之间,本实施例一中采用0.2mm直径的镍钛丝编织而成,Z形或正弦波的支撑单元110数量为8个,环形支撑架100的波高为5.5mm。
从支架形状上讲,本发明的支架可以是每圈环形支撑架100直径相同的等径支架,也可以是环形支撑架100直径不同的非等径支架。非等径支架和等径支架中柔性连接件200的结构以及连接方式相同,本实施例以等径支架为例进行详细说明:
对于等径支架,支撑单元110分为两种情况,一种是在轴向上不同圈的支撑单元110的波长相同,而轴向上不同圈环形支撑架100中,支撑单元110可以轴向对应排布,即轴向相邻的波峰与波峰、波谷与波谷一一对应,也可以交错排布,即轴向上相邻两个支撑单元110相互交错一定间距,例如一个支撑单元110的波峰111轴向对应另一个支撑单元110的波杆112,形成螺旋排布。本发明优选在轴向上不同圈的支撑单元110的波长相同,且轴向相邻的波峰与波峰、波谷与波谷一一对应成列排布,这样相邻两圈环形支撑架100中,所述第一柔性连接件210连接在轴向不同列的两个支撑单元110的波峰111和波谷113之间。
另一种是在轴向上不同圈的支撑单元110的波长不相同,也可使得轴向上不同圈环形支撑架100中,支撑单元110可以轴向对应排布,例如一圈一个支撑单元110对应另一圈的两个或多个支撑单元110,也可以交错排布。
本发明中,第一柔性连接件210和第二柔性连接件220的柔性指可以任意弯曲、扭转,在轴向上不能拉伸或微拉伸的结构,优选第一柔性连接件210和第二柔性连接件220各自 分别为线状结构、条状结构或带状结构。还可以优选第一柔性连接件210和第二柔性连接件220为轴向上在多个波峰111和波谷113之间、不同支撑单元110上连续缠绕的一根线状结构、条状结构或带状结构。在线状结构、条状结构或带状结构中,优选线状结构。
所述第一柔性连接件210是连接在轴向相邻两圈支撑单元110的波峰111和波谷113之间,所述第一柔性连接件210具体是一个支撑单元110远端的波谷113与相邻圈相邻列最靠近的一个支撑单元110近端的波峰111之间连接,连接方式可以是通过打结方式连接,也可以是通过缠绕方式连接。打结方式是该第一柔性连接件210两端分别打结固定在波谷113和波峰111上。缠绕方式是该第一柔性连接件210缠绕在波谷113和波峰111上。在波峰111和波谷113之间的第一柔性连接件210的长度根据需要确定。
第一柔性连接件210和第二柔性连接件220之间可以是各自独立设置,即第一柔性连接件210两端缠绕或打结固定在波峰111和波谷113上,第二柔性连接件220的两端缠绕或打结固定在支撑单元110上。也可以是第一柔性连接件210和第二柔性连接件220连续设置,优选第一柔性连接件210和第二柔性连接件220连接在一起或一体结构。一体结构连接也分为两种情况:一种是一对波峰111和波谷113之间的第一柔性连接件210与同一支撑单元110的第二柔性连接件220为一体结构,另一种是第一柔性连接件210和第二柔性连接件220在轴向上在多个波峰111和波谷113之间、不同支撑单元110上连续缠绕,特别优选的是在连接轴向相邻两圈的支撑单元100的第一柔性连接件210和缠绕其中一圈的第二柔性连接件220为一体结构。
在进一步的实施例中,第一柔性连接件210至少和缠绕在其相邻圈且相邻两列支撑单元中的一列的第二柔性连接件220连续连接,所述连续连接是指所述第一柔性连接件210和所述第二柔性连接件220为一体结构,或者所述第一柔性连接件210和所述第二柔性连接件通过打结或者其他的方式连接在一起,二者之前有相互牵拉的拉力,连接轴向两圈支撑单元100的第一柔性连接件210通过连续连接的第二柔性连接件220在相邻列支撑单元上的缠绕固定,能够进一步加强支架整体结构的连续性和稳定性。在更进一步的实施例中,连接轴向相邻两圈环形支撑架的第一柔性连接件210和其中一圈环形支撑架上的第二柔性连接件220是一体连接的线状、条状或者带状结构。
在一对波峰111和波谷113之间的第一柔性连接件210,可以分别缠绕固定或打结固定在波峰111和波谷113上,波峰111和波谷113之间的第一柔性连接件210的长度根据要求弯曲程度以及支架本身性能确定,本发明不作限定,优选连接保持轴向上多个支撑单元110对应,不作扭转或径向偏移,保持整体支架呈筒状结构。
对于设置在支撑单元110波杆112上的第二柔性连接件220,根据缠绕长度,有多种实施方式,可以分为全缠绕支撑单元和半缠绕支撑单元,其中全缠绕支撑单元是整个支撑单元110都缠绕有第二柔性连接件220,而半缠绕支撑单元只是部分缠绕有第二柔性连接件220。即优选所述缠绕支撑单元101为第二柔性连接件220将一个支撑单元110的波峰111、波杆112和波谷113全部缠绕的全缠绕支撑单元;或者还可以优选所述缠绕支撑单元101为第二柔性连接件220将一个支撑单元110由波峰111缠绕至波杆112、或者由波谷113缠绕至波杆112的半缠绕支撑单元。在缠绕支撑单元101上的所述第二柔性连接件220顺序螺旋缠绕在支撑单元110上并且每圈之间留有间距。所述螺旋缠绕为顺时针缠绕或逆 时针缠绕。
缠绕支撑单元101的设置优点是:通过缠绕支撑单元101的设置可以在使轴向相邻的两圈支撑架100之间通过连续的第一柔性连接件210和第二柔性连接件220连接成一个整体,同时,能够通过缠绕的方式,跨过部分波峰111,使得部分波峰111未束缚在第一柔性连接件210上,从而,支架整体上包括部分可自由活动的裸支架单元102,同时保证支架的稳定性和柔顺性。连续的缠绕固定可以保证轴向相邻两圈环形支撑架100之间的连续性,进而保证整个支架的连续性,增强支架的径向支撑强度以及支架整体连接的稳定性。
在两圈环形支撑架100之间设置的一圈第一柔性连接件210中,第一柔性连接件210排布也是有多种实施方式,例如同一圈的第一柔性连接件210连接的方向相同,即一圈环形支撑架100中的波峰111只与左侧相邻的波谷113连接或只与右侧相邻的波谷113连接;还可以是同一圈的第一柔性连接件210连接的方向不同,即一圈环形支撑架100中的波峰111可以与左侧相邻或右侧相邻的波谷113连接;也可以是所述第一柔性连接件210同时在一个支撑单元110的波峰111与相邻圈中两个相邻列的支撑单元110的波谷113之间连接,以形成倒八字形的连接结构,该连接结构能使得连接更为稳定,防止相邻两圈环形支撑架100之间形成扭转和偏移。
由于部分支撑单元110缠绕有第二柔性连接件220,则所述支撑单元110包括被所述第二柔性连接件220缠绕的缠绕支撑单元101,未被第二柔性连接件220缠绕的裸支撑单元102;缠绕支撑单元101和裸支撑单元102交替设置,那么支撑单元110的排布方式有多种实施方式:同一圈环形支撑架100中,缠绕支撑单元101和裸支撑单元102交替重复排布一圈。在轴向上,不同圈的缠绕支撑单元101和裸支撑单元102交替重复排布一列。具体地,本发明中此处的交替是指缠绕支撑单元101和裸支撑单元102按照一定规律重复排布。即同一圈环形支撑架100中,所述缠绕支撑单元101和裸支撑单元102按照一定排布规则交替重复排布一圈,排布规则是指缠绕支撑单元101和裸支撑单元102之间的交替规则,可以是1-4个缠绕支撑单元101与1-4个裸支撑单元102组合进行重复排布,例如:一个缠绕支撑单元101和一个裸支撑单元102交替、一个缠绕支撑单元101和两个裸支撑单元102交替、两个缠绕支撑单元101和一个裸支撑单元102交替等等,排布规则根据实际需要的支架柔顺性、支撑力等条件确定,本发明不作限定。
本实施例中,每一个波谷113上均连接第一柔性连接件210,部分波峰111上连接第一柔性连接件210,那么第一柔性连接件210的该种排布方式使得同一圈波形支撑架100中,缠绕支撑单元101与裸支撑单元102交替间隔排布。
对于不同圈之间支撑单元110的排布也是遵循交替规则:不同圈的所述缠绕支撑单元101和裸支撑单元102按照排布规则交替重复排布一列。同样根据柔顺性要求,可以任意设定交替规则,可以是轴向上1-4个缠绕支撑单元101与1-4个裸支撑单元组合进行重复排布。例如:在轴向上,一个缠绕支撑单元101和一个裸支撑单元102交替、一个缠绕支撑单元101和两个裸支撑单元102交替、两个缠绕支撑单元101和一个裸支撑单元102交替等等。在轴向上,不对应的支撑单元110也可以根据上述交替规则,在周向上偏移一定距离,形成螺旋形的交替排布。
本实施例中,如图3所示,环形支撑架100通过第一柔性连接件210和第二柔性连接件220保持轴向连接,第一柔性连接件210和第二柔性连接件220一体结构。在近端首圈环形支撑架100上,第二柔性连接件220通过缠绕的方式从环形支撑架100的波谷113开始顺时针沿着波杆112,波峰111缠绕至下一个波谷113,然后第一柔性连接件210向下缠绕通过第二圈环形支撑架100的邻近波峰111,然后再向上,第二柔性连接件220缠绕首圈环形支撑架100的波谷113。以此循环,环形支撑架100上每间隔一个波峰111缠绕第一柔性连接件210,第一柔性连接件210和第二柔性连接件220围绕一圈后回到环形支撑架100上起始位置的前一个波谷113位置。第二圈环形支撑架100上从相对于首圈环形支撑架100绕线位置后一个波谷113位置开始缠绕,缠绕方式与首圈缠绕方式相同,直至远端倒数第二圈。每圈第一柔性连接件210和第二柔性连接件220为一条整体结构缠绕形成,本发明所用的第一柔性连接件210和第二柔性连接件220采用高分子材料或金属材料的线状结构,优选是PET线、PP线、PTFE线,直径在0.02~0.05mm之间,本实例一采用的直径是0.03mm的PTFE线,或者也可采用较细的记忆合金丝例如镍钛合金丝,或者较细的多股丝组合,所述多股丝的组合可以是高分子材料之间的组合、金属材料的组合或者高分子材料和金属材料的组合。远端的一圈环形支撑架除了部分波峰连接有第一柔性连接件210外,支撑单元本身没有延伸第二柔性连接件220,为裸支撑单元102。
如图4所示,本实施例中第一柔性连接件210和第二柔性连接件220以缠绕的方式包裹在环形支撑架100上,第一柔性连接件210从上一圈环形支撑架100的波谷113往下缠绕过下一圈环形支撑架100的波峰111,再往上绕回上一圈环形支撑架100的波谷113位置,在波峰111、波谷113位置缠绕圈数为2~4圈,或者在波峰111和波谷113位置打结固定。
本实施例中,轴向上相邻两圈环形支撑架100的波谷113位于同一轴线上,即轴向相邻两圈环形支撑架100的波谷113与波峰111轴向对应,轴向相邻两圈环形支撑架100的波峰111与波峰111相对,第一柔性连接件210间隔一个波峰111缠绕固定连接相邻两圈环形支撑架100,在相邻两圈环形支撑架100之间形成一个稳定的近菱形闭环结构,稳定的闭环结构能够保证支架整体的径向和轴向稳定性,同时还包括数个未束缚波峰111的裸支撑单元102,能够保证环形支撑架100的一定的活动空间,加强支架的柔顺性;另一方面相邻两圈环形支撑架100通过第一柔性连接件210和第二柔性连接件220连接,有利于提高支架的弯曲柔顺性。
实施例二
本实施例是在实施例一的基础上的改进。
如图5所示,本发明实施例的环形支撑架100为等高波支架,由多圈环形支撑架100和多圈第一柔性连接件210和第二柔性连接件220连接而成。该实施例与实施例一之间的区别在于:缠绕支撑单元101和裸支撑单元102交替规律与实施例一不同。同一圈中,两个缠绕支撑单元101和一个裸支撑单元形成交替规律,排布一圈;轴向上,两个缠绕支撑单元101和一个裸支撑单元形成交替规律。第一柔性连接件210和第二柔性连接件220连续缠绕两个支撑单元110后间隔一个支撑单元110,再缠绕,即一个波峰111与相近的 两个波谷113连接,中间间隔两个波峰111未被第一柔性连接件210束缚,未束缚的波峰111数量多于实施例一,进一步增强支架的柔顺性。
如图5所示,实施例二中近端首圈环形支撑架100从起始位置的波谷113缠绕第二柔性连接件220形成一个全缠绕支撑单元,再至波谷113,顺时针连续缠绕两个支撑单元110后在波谷113位置向下缠绕第一柔性连接件210通过第二个环形支撑架100的波峰111位置,再向上在间隔一个波峰111的波谷113处缠绕回首圈环形支撑架100的支撑单元110,继续以此方式顺时针缠绕回起始位置的的波谷113位置,打结固定。第二圈环形支撑架100上从相对于首圈环形支撑架100起始位置绕线的后一个波谷113位置开始缠绕。
其余结构与实施例一相同,在此不再赘述。
实施例三
本实施例是在实施例一的基础上的改进。
如图6所示,本发明实施例三与实施例一之间的区别在于,环形支撑架100为有两种,等高波支撑架和高低波支撑架。近端首圈为等高波支撑架,其余为高低波支撑架。其中,高低波支撑架是一个高波支撑单元和一个低波支撑单元交替组成。可以理解地,在其他实施例中,还可以选择两个或多个高波支撑单元和一个低波支撑单元交替,或者一个高波支撑单元和两个或多个低波支撑单元交替,或者两个或多个高波支撑单元和两个或多个低波支撑单元交替。
如图6所示,实施例三中近端首圈环形支撑架100是等高波支撑架,从第二圈环形支撑架100开始为高低波支撑架轴向排列。高低波支撑架中,高波支撑单元与低波支撑单元的高度差在0.5~1mm之间。所述环形支撑架100为高波支撑单元和低波支撑单元组成的高低波支架,其低波支撑单元的波峰111连接第一柔性连接件210、高波支撑单元的波峰111不连接第一柔性连接件210。
具体地,第二柔性连接件220的缠绕是从首圈环形支撑架100起始位置的的波谷113缠绕,顺时针连续缠绕过波杆112、波峰111,在下一个波谷113处向下第一柔性连接件210缠绕过第二圈环形支撑架100的低波支撑单元110的波峰111,第一柔性连接件210再向上缠绕回首圈环形支撑架100的波谷113,顺时针以此缠绕回起始位置的前一个波谷113,打结固定。第二圈环形支撑架100上从相对于首圈环形支撑架100绕线位置后一个波谷113位置开始缠绕第二柔性连接件220,缠绕方式与实施例一相同。本实施例中,轴向上,环形支撑架100采用高波支撑单元110与低波支撑单元110交错排布,扩大了环形支撑架100的弯曲角度,提升了柔顺性。
其余结构与实施例一相同,在此不再赘述。
实施例四
本实施例是在实施例一的基础上的改进。
如图7所示,本实施例与实施例一之间的区别在于,缠绕支撑单元101和裸支撑单元102交替规律与实施例一不同。同一圈中,两个缠绕支撑单元101交替一个裸支撑单元102,再接着交替一个缠绕支撑单元101,最后交替一个裸支撑单元102,按照这样的交 替规律,排布一圈;轴向上,第一列除第一个为缠绕支撑单元101外,其余是一个裸支撑单元102交替两个缠绕支撑单元101,形成交替规律,相邻的第二列是两个缠绕支撑单元101交替一个裸支撑单元102形成交替规律。第三列是一个裸支撑单元102交替两个缠绕支撑单元101,形成交替规律;第四列同第一列,第五列中除第一个为裸绕支撑单元102外,其余是是一个缠绕支撑单元101交替两个裸支撑单元102;第六列同第一列,第七列同第二列,以此规律排布。第一柔性连接件210连接一个波峰111与相近的两个波谷113连接,中间间隔一个或两个波峰111未被柔性连接件200束缚。即同一圈环形支撑架100中,每一个波谷113上均连接第一柔性连接件210,部分波峰111上连接第一柔性连接件210。
如图7所示,实施例四中近端首圈环形支撑架100从波谷113位置缠绕柔性连接件200,顺时针连续缠绕过两个波峰111,在第二个波谷113处向下缠绕过第二圈环形支撑架100的波峰111,再向上缠绕回首圈环形支撑架100的波谷113,再顺时针缠绕环形支撑架100的一个波形,在波谷113处向下缠绕第二圈支架波峰111,再向上缠绕回首圈环形支撑架100的波谷113,顺时针以此缠绕回起始位置的波谷113,打结固定。第二圈环形支撑架100上从相对于首圈环形支撑架100绕线位置后一个波谷113位置开始缠绕柔性连接件200,方式与首圈相同。未束缚的波峰111和波谷113数量多于实施例一,进一步增强支架的柔顺性。
其余结构与实施例一相同,在此不再赘述。
实施例五
本实施例是在实施例一的基础上的改进。
所述的高柔顺性支架中,除了环形支撑架100组成的裸支架外,所述支架还包括管状的覆膜300,所述环形支撑架100轴向顺次排布并固定在所述覆膜300内表面或/和外表面。本实施例为两层覆膜300,所述覆膜300包括内层覆膜301和外层覆膜302,是两个管状覆膜300套装在一起形成内层覆膜301和外层覆膜302。所述环形支撑架100设置在内层覆膜301和外层覆膜302之间。
如图8所示,内层覆膜301呈管状一体式结构,位于支架内层,用于支撑整个支架的管状结构的作用。外层覆膜302呈管状一体式结构,位于支架最外层,其覆盖在环形支撑架100和所述第一柔性连接件210和所述第二柔性连接件220的外表面。环形支撑架100、所述第一柔性连接件210和所述第二柔性连接件220被内层覆膜300和外层覆膜300夹持在其两者之间,从而能够维持支架的整体结构,为进一步提高支架结构整体的稳定性,内层覆膜301与外层覆膜302可通过热合的方法合为一体。本实施例中覆膜300材料采用的是PET或ePTFE等高分子膜,内层覆膜301和外层覆膜302均可采用1-5层高分子膜复合而成,例如分别由3层膜结构复合形成。当所述第一柔性连接件210和所述第二柔性连接件220采用PET线、PP线、PTFE等高分子线的材料时,热压后,缠绕在支撑架上的所述第一柔性连接件210和所述第二柔性连接件220能够与高分子膜能够融合的更好,覆膜支架整体结构更稳定。
环形支撑架100和所述第一柔性连接件210和所述第二柔性连接件220的结构同实施例一,在此不再赘述。
实施例六
本实施例是在实施例三的基础上的改进。
如图9所示,本实施例是在实施例三裸支架内外设有覆膜300。优选所述环形支撑架100为高波支撑单元和低波支撑单元组成的高低波支架,所述高低波支架固定在覆膜300内表面或外表面,低波支撑单元与覆膜300固定,高波支撑单元110的波峰111与覆膜300之间不固定。
优选支架包括环形支撑架100、所述第一柔性连接件210和所述第二柔性连接件220、内层覆膜301和外层覆膜302;所述环形支撑架100、所述第一柔性连接件210和所述第二柔性连接件220位于支架中层,内层覆膜301和外层覆膜302之间。该实施例与实施例五之间的区别在于,裸支架的结构为高低波结构,且高波波峰111未被外层覆膜302包裹。
内层覆膜301呈管状一体式结构,位于环形支撑架100内侧。如图10所示,外层覆膜302轴向间隔排列的多层环状结构,每一圈外层覆膜302从环形支撑架100的矮波峰111开始包裹,至下一环形支撑架100的波谷113为止,将高波的波峰111露出来。当支架弯曲时,未被束缚的波峰111不会限制覆膜支架的弯曲活动,因此本实施例中的覆膜300方式提升了支架的轴向柔顺性。
其余结构与实施例三相同,在此不再赘述。
Claims (20)
- 一种高柔顺性支架,包括轴向排列的多个环形支撑架,所述环形支撑架由多个波形的支撑单元首尾相接形成,所述支撑单元包括波峰、波谷、连接在波峰和波谷之间的波杆,其特征在于,相邻两圈环形支撑架中,多个不同圈支撑单元的波峰和波谷之间通过第一柔性连接件连接,且所述第一柔性连接件还延伸缠绕到至少一个支撑单元上形成第二柔性连接件。
- 根据权利要求1所述的高柔顺性支架,其特征在于,在轴向上不同圈的支撑单元的波长相同,且轴向上一一对应成列排布,相邻两圈环形支撑架中,所述第一柔性连接件连接在轴向不同列的两个支撑单元的波峰和波谷之间。
- 根据权利要求2所述的高柔顺性支架,其特征在于,所述第一柔性连接件同时在一个支撑单元的波峰与相邻圈中两个相邻列的支撑单元的波谷之间连接,以形成倒八字形的连接结构。
- 根据权利要求3所述的高柔顺性支架,其特征在于,同一圈环形支撑架中,每一个波谷上均连接第一柔性连接件,部分波峰上连接第一柔性连接件。
- 根据权利要求1所述的高柔顺性支架,其特征在于,所述第一柔性连接件至少与其连接支撑单元相邻列的第二柔性连接件连续连接。
- 根据权利要求5所述的高柔顺性支架,其特征在于,连接轴向相邻两圈支撑单元的第一柔性连接件和其中一圈支撑单元上的第二柔性连接件是连续连接的。
- 据权利要求6所述的高柔顺性支架,其特征在于,连接轴向相邻两圈环形支撑架的第一柔性连接件和其中一圈环形支撑架上的第二柔性连接件是一体结构。
- 据权利要求7所述的高柔顺性支架,其特征在于,轴向上,至少相邻两列的第一柔性连接件和第二柔性连接件是从近端到远端的一体结构。
- 根据权利要求1所述的高柔顺性支架,其特征在于,所述第二柔性连接件顺序螺旋缠绕在支撑单元上并且每圈之间留有间距。
- 根据权利要求9所述的高柔顺性支架,其特征在于,所述螺旋缠绕为顺时针缠绕或逆时针缠绕。
- 根据权利要求1所述的高柔顺性支架,其特征在于,所述支撑单元包括被所述第二柔性连接件缠绕的缠绕支撑单元,以及未被第二柔性连接件缠绕的裸支撑单元,缠绕支撑单元和裸支撑单元交替设置。
- 根据权利要求11所述的高柔顺性支架,其特征在于,同一圈环形支撑架中,缠绕支撑单元和裸支撑单元交替重复排布。
- 根据权利要求11所述的高柔顺性支架,其特征在于,在轴向上,不同圈的缠绕支撑单元和裸支撑单元交替重复排布一列。
- 根据权利要求11所述的高柔顺性支架,其特征在于,所述缠绕支撑单元为柔性连接件将一个支撑单元的波峰、波杆和波谷全部缠绕的全缠绕支撑单元;或者所述缠绕支撑单元为柔性连接件将一个支撑单元由波峰缠绕至波杆、或者由波谷缠绕至波杆的部分缠绕支撑单元。
- 根据权利要求1所述的高柔顺性支架,其特征在于,所述第一柔性连接件和第二柔性连接件分别各自为线状结构、条状结构或带状结构。
- 根据权利要求1所述的高柔顺性支架,其特征在于,所述环形支撑架为高波支撑单元和低波支撑单元组成的高低波支架,其低波支撑单元的波峰连接第一柔性连接件、高波支撑单元的波峰不连接第一柔性连接件。
- 根据权利要求1所述的高柔顺性支架,其特征在于,所述第一柔性连接件在不同圈支撑单元的波峰和波谷之间通过打结或缠绕方式连接。
- 根据权利要求1-18任意一项所述的高柔顺性支架,其特征在于,所述支架还包括管状的覆膜,所述环形支撑架轴向顺次排布并固定在所述覆膜内表面或/和外表面。
- 根据权利要求19所述的高柔顺性支架,其特征在于,所述环形支撑架为高波支撑单元和低波支撑单元组成的高低波支架,所述高低波支架固定在覆膜外表面或内表面,低波支撑单元与覆膜固定,高波支撑单元的波峰与覆膜之间不固定。
- 根据权利要求20所述的高柔顺性支架,其特征在于,所述覆膜包括内层覆膜和外层覆膜,所述环形支撑架设置在内层覆膜和外层覆膜之间。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17/165,264 US11712354B2 (en) | 2018-08-02 | 2021-02-02 | Highly flexible stent |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201810873465.6 | 2018-08-02 | ||
CN201821240872.5 | 2018-08-02 | ||
CN201810873465.6A CN110786972A (zh) | 2018-08-02 | 2018-08-02 | 一种高柔顺性的血管支架 |
CN201821240872.5U CN209285856U (zh) | 2018-08-02 | 2018-08-02 | 一种高柔顺性的血管支架 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US17/165,264 Continuation US11712354B2 (en) | 2018-08-02 | 2021-02-02 | Highly flexible stent |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2020024936A1 true WO2020024936A1 (zh) | 2020-02-06 |
Family
ID=69231446
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/CN2019/098375 WO2020024936A1 (zh) | 2018-08-02 | 2019-07-30 | 高柔顺性支架 |
Country Status (2)
Country | Link |
---|---|
US (1) | US11712354B2 (zh) |
WO (1) | WO2020024936A1 (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023185470A1 (zh) * | 2022-03-30 | 2023-10-05 | 亿恒智慧(北京)能源技术有限公司 | 一种光伏发电支架系统及其安装方法 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5897589A (en) * | 1996-07-10 | 1999-04-27 | B.Braun Celsa | Endoluminal medical implant |
US20040176832A1 (en) * | 2002-12-04 | 2004-09-09 | Cook Incorporated | Method and device for treating aortic dissection |
CN206403891U (zh) * | 2016-08-25 | 2017-08-15 | 北京奇伦天佑创业投资有限公司 | 一种覆膜支架结构 |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6551350B1 (en) * | 1996-12-23 | 2003-04-22 | Gore Enterprise Holdings, Inc. | Kink resistant bifurcated prosthesis |
US10022250B2 (en) * | 2007-12-12 | 2018-07-17 | Intact Vascular, Inc. | Deployment device for placement of multiple intraluminal surgical staples |
CN105769383B (zh) * | 2016-03-18 | 2019-12-10 | 杭州唯强医疗科技有限公司 | 一种主动脉裸支架及主动脉夹层支架 |
-
2019
- 2019-07-30 WO PCT/CN2019/098375 patent/WO2020024936A1/zh active Application Filing
-
2021
- 2021-02-02 US US17/165,264 patent/US11712354B2/en active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5897589A (en) * | 1996-07-10 | 1999-04-27 | B.Braun Celsa | Endoluminal medical implant |
US20040176832A1 (en) * | 2002-12-04 | 2004-09-09 | Cook Incorporated | Method and device for treating aortic dissection |
CN206403891U (zh) * | 2016-08-25 | 2017-08-15 | 北京奇伦天佑创业投资有限公司 | 一种覆膜支架结构 |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023185470A1 (zh) * | 2022-03-30 | 2023-10-05 | 亿恒智慧(北京)能源技术有限公司 | 一种光伏发电支架系统及其安装方法 |
Also Published As
Publication number | Publication date |
---|---|
US11712354B2 (en) | 2023-08-01 |
US20210154034A1 (en) | 2021-05-27 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US10624768B2 (en) | Luminal stent | |
JP6556774B2 (ja) | ステント部材 | |
US10702370B2 (en) | Lumen stent | |
CN107981956B (zh) | 一种可塑性主动脉夹层覆膜支架及主动脉夹层支架 | |
CN105769383B (zh) | 一种主动脉裸支架及主动脉夹层支架 | |
CN102973341B (zh) | 一种编织的自膨式管腔支架及其制作方法 | |
CN209107690U (zh) | 分段式覆膜支架 | |
CN109350304B (zh) | 高顺应性覆膜支架 | |
WO2019096158A1 (zh) | 血管支架 | |
CN210301319U (zh) | 一种改进贴壁性能的覆膜血管支架 | |
CN110623780A (zh) | 分段式覆膜支架及其制备方法 | |
CN109419568A (zh) | 覆膜支架 | |
RU2714460C2 (ru) | Стент-графт | |
CN209285856U (zh) | 一种高柔顺性的血管支架 | |
WO2019128703A1 (zh) | 覆膜支架 | |
WO2020024936A1 (zh) | 高柔顺性支架 | |
CN209107678U (zh) | 血管覆膜支架 | |
CN111317595A (zh) | 一种防止覆膜滑脱的血管支架 | |
CN110786972A (zh) | 一种高柔顺性的血管支架 | |
CN208910580U (zh) | 覆膜支架 | |
CN208851726U (zh) | 外周血管支架 | |
WO2022178740A1 (zh) | 一种外周血管支架及其制备方法和应用 | |
CN110393607B (zh) | 覆膜支架 | |
CN109966016A (zh) | 覆膜支架 | |
CN202982316U (zh) | 一种编织的自膨式管腔支架 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 19844767 Country of ref document: EP Kind code of ref document: A1 |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
122 | Ep: pct application non-entry in european phase |
Ref document number: 19844767 Country of ref document: EP Kind code of ref document: A1 |