WO2018082278A1 - 血管支架 - Google Patents

血管支架 Download PDF

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Publication number
WO2018082278A1
WO2018082278A1 PCT/CN2017/083721 CN2017083721W WO2018082278A1 WO 2018082278 A1 WO2018082278 A1 WO 2018082278A1 CN 2017083721 W CN2017083721 W CN 2017083721W WO 2018082278 A1 WO2018082278 A1 WO 2018082278A1
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WO
WIPO (PCT)
Prior art keywords
wave
blood vessel
stent
bracket
peak
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.)
Ceased
Application number
PCT/CN2017/083721
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English (en)
French (fr)
Inventor
肖本好
王逸斐
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.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen 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
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Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Priority to US16/346,195 priority Critical patent/US11497636B2/en
Publication of WO2018082278A1 publication Critical patent/WO2018082278A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A61F2/852—Two or more distinct overlapping stents
    • 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
    • A61F2/856—Single tubular stent with a side portal passage
    • 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
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • A61F2250/0024—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity made from both porous and non-porous parts, e.g. adjacent parts
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0037—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in height or in length
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present invention relates to the field of interventional medical device technology, and in particular to a blood vessel stent.
  • the self-expanding blood vessel bare stent is divided into two types: a nickel-titanium tube cutting bracket and a nickel-titanium wire braiding bracket.
  • the nickel-titanium wire braided stent needs to have better flexibility when conforming to the anatomy of the blood vessel.
  • the bare stent may have a structure as shown in FIG. 2-1: at least two of the two spaced apart peaks and one of the other coils adjacent to the coil.
  • connection point A The mutually separated troughs are fixedly connected to form a connection point A; the remaining crests and troughs of the two cavitation are suspended and are not connected to each other.
  • the bare stent can fit the vessel wall well after implantation, but the peaks and troughs that are not connected to each other in the adjacent two coils are prone to excessive deformation as shown in Figure 2-2, resulting in poor stability of the stent structure.
  • the assembly has certain difficulty; when released, the peaks and troughs that are not connected to each other in the coil are too free. It will cause the stent to not maintain its shape during the process of sheathing the tube, and even affect the stent release or damage the vessel wall in severe cases.
  • the stability and compliance of the stent can be adjusted by adjusting the ratio and arrangement of the connection point A and the floating space F.
  • the more the connection point A the more stable the stent is, and the softness is lowered, and the flexibility of the stent is improved, and the stability is lowered.
  • it does not enable the stent to have a stable and unbreakable morphology, while at the same time meeting the complex and variable vascular anatomy and safe and reliable release performance.
  • the invention provides a blood vessel stent comprising a plurality of wave coils arranged in an axial direction.
  • a blood vessel stent comprising a plurality of wave coils arranged in an axial direction.
  • Partial troughs are constrained to connect, and another portion of the wave of the lower layer of the wave passes through another portion of the valley of the upper layer of the wave and the other portion of the peak is non-contact with the valley.
  • Said non Contact-type mutual connection means that in the natural state, the peak of the lower layer coil and the valley of the upper layer circle interpenetrate, and the apex of the peak has a certain distance from the apex of the valley, if and only when the bracket is axially stretched
  • the troughs and crests are in contact with each other and are mutually constrained to define the elongate length of the stent.
  • Each of the coils is comprised of a plurality of circumferentially arranged waveforms; the waveforms include peaks, troughs, and rods that connect adjacent peaks and troughs.
  • the valleys of the same wave circle are circumferentially aligned, and the peaks are different in height.
  • the peaks of different heights are realized by the peaks of different heights, respectively, the peaks/valleys A of the constrained connections and the non-contact interconnections (inter-connected) And the peaks/troughs B that do not touch each other in a natural state.
  • the peak non-contacting with the trough is located in a small curved side region of the blood vessel stent and has a vertex angled portion of the eversion angle a.
  • the waveform of the connection point B method using the non-contact inter-connected connection has a higher peak of the lower layer coil, which causes the bracket to bend, and when the side is located on the small curved side, the mutual displacement/torsion of the waveform causes a higher peak to be lifted.
  • the same retracement of the conveyor system poses a certain risk of scraping, which may cause the waveform to shift due to the collision of the conveyor system and the wave circle, and the peak of the lift will have a certain influence on the hemodynamics.
  • the apex angled portion of the valgus angle ⁇ can effectively resolve the peak of the wave peak, so that the anchoring effect of the small curved side of the bracket is better, and the displacement of the transport system to the bare bracket is reduced. The risk of deformation/folding.
  • the apex angle of the valgus angle ⁇ appears on the large curved side of the stent, the apex angle of the protrusion and the blood vessel wall will not be able to fit, which will result in a decrease in the adherence of the large curved side of the stent, and when the stent is When the relative blood vessel is large, the apex angle of the protrusion will cause certain stimulation and even damage to the blood vessel wall, so the distribution and position of the apex angle folding part need to be rationally designed according to the design goal of the stent.
  • the apex fold can be used more to optimize the small curved side of the stent.
  • a partial peak of the lower coil is constrained to a partial trough of the upper coil, and another peak of the lower coil and the upper coil are further Some of the troughs are suspended.
  • the waveform is suspended on the side of the stent relative to the branch vessel, which provides a simple operation solution for intraoperative window opening and placement of the branch bracket.
  • the peaks of the lower layer coil and the valleys of the upper layer coil are in addition to a part of the constraint connection and a part of the non-contact type interconnection, and include Floating crests and troughs.
  • the vascular stent may be an aortic arch stent, or a vascular stent that needs to be used in conjunction with a branch stent after in-situ fenestration on the circumferential surface.
  • the distance between the peak apex of the at least two sets of non-contact inter-connected and the vertices of the trough is not equal.
  • the stent is further improved in conformity with the angle of the compliant aorta; while the stent conforms to the angle of the aorta, the inner wall of the stent does not generate excessive peaks/valleys, and the small curved side is smooth and large. The curved side is fully open and can be fully attached.
  • a distance between a peak apex of the non-contact interlaced lower layer wave and a valley apex of the upper layer coil is 1/4 to 1 of a waveform height of the upper layer coil.
  • the upper layer wave of the connection point A of the constrained connection is used.
  • the waveforms of the circle and the lower layer of the coil cannot be moved.
  • the waveforms of the upper layer and the lower layer of the connection point B which are connected by the non-contact type are connected to each other, and finally contact and limit the elongation of the bracket further, and finally the axial length of the bracket H
  • the tensile elongation is H2
  • the stent elongation (H2-H) is generally less than or equal to the peak apex of the non-contact interlaced lower layer coil of the connection point B and the valley apex of the upper layer wave without considering the waveform deformation.
  • the distance L2 is generally less than or equal to the peak apex of the non-contact interlaced lower layer coil of the connection point B and the valley apex of the upper layer wave without considering the waveform deformation.
  • the alpha angle is 20-30 degrees.
  • the height of the vertex-folding portion along the axial direction of the blood vessel support ⁇ is the distance between the peak apex of the non-contact-intersected lower layer wave and the apex of the upper layer wave.
  • the valleys of the lower layer coils are located on a circular ring coaxial with the axis of the blood vessel support, and the lower layer waves that are non-contacting with the upper layer of the wave coil have different wave heights.
  • the suspended crests and troughs each have 2-4.
  • the number of suspended crests and troughs is adjusted by the specific part of the stent and the diameter of the branch vessel; the larger the diameter of the branch vessel, the more cavitation peaks and troughs need to be set.
  • the constrained connection ensures the basic shape and lower elongation of the stent.
  • the non-contact inter-connected connection and the suspended peaks and troughs provide better flexibility for the stent.
  • the distance between the waveforms can be separated more on the basis of the suspended peaks and troughs, which provides space for implanting the branch bracket.
  • the branch stent conveyor can easily pass through the area where the crests and troughs of the dangling are located.
  • the released branch scaffold is not subjected to the aortic stent wave in the suspended area. Larger rebound force to ensure the smooth flow of blood in the branch vessels.
  • the vascular stent further comprises a stent graft segment, the plurality of coils forming a bare stent, the bare stent being connected to one end of the stent graft segment, for example, the vascular stent may be an abdominal aortic graft Membrane support.
  • the blood vessel stent includes an inner layer bracket and an outer layer bracket, the outer layer bracket is sleeved outside the inner layer bracket, and at least one end is sealingly connected with an outer surface of the inner layer bracket;
  • the inner layer bracket comprises a metal bracket and a coating covering the surface of the metal bracket.
  • the outer bracket may be in the shape of a skirt, one end is sealingly connected to the surface of the inner layer bracket, and the other end is open; for example, the outer bracket may be a lantern It is sealed at both ends and connected to the surface of the inner support.
  • connection points of the constrained connections are uniformly distributed in the circumferential direction of the blood vessel stent, and the lines in the axial direction are spiral.
  • the multi-layered wave ring bracket formed by the arrangement provides axial tensile strength from the connection point of the constrained connection, the structure is stable, the axial elongation is low, and there is a part of the shortened space, which can be provided by the close proximity between the coils.
  • the connection point A of the spiral in the axial direction eliminates the directionality of the overall physical properties of the bracket; the connection point B of the non-contact type of interconnected connection can make the peak of the connection method/
  • the troughs are in a state of relative freedom and non-interference. In this state, the coils have a certain displacement/deformation space in the axial direction, which can be relatively distant or relatively close, so that the compliance of the bracket is further improved.
  • a partial peak of the lower layer coil is fixedly connected with a partial trough of the upper layer coil to form the constrained connection; or a partial peak of the lower layer coil passes through a partial trough of the upper layer coil and is directly contacted to form The constraint is connected.
  • each of the coils has 8 waveforms.
  • the invention adopts one or more non-contact mutual connection on the woven support, instead of the partial constraint connection, the peaks of the upper layer wave circle and the lower layer wave circle interpenetrate in the natural state, only when the bracket is elongated The apex will be in contact, giving the stent maximum flexibility and overall stability.
  • the stent ensures good shape during assembly and release, ensuring release safety.
  • FIG. 1 is a schematic view showing the flexibility of a prior art nickel-titanium wire braided stent after implantation into a blood vessel;
  • 2-1 is a schematic structural view of a bare stent of a prior art having mutually constrained peaks/valleys and suspended peaks/valleys;
  • FIG. 2-2 is a schematic view showing deformation of the bare bracket shown in FIG. 2-1;
  • 3-1 is a schematic structural view of a stent of Embodiment 1;
  • 3-2 is a schematic structural view of the stent of the embodiment 1 after being axially cut;
  • 3-3 is a schematic exploded view showing the stent of Example 1 subjected to tensile stress
  • Figure 4-1 is a schematic view showing the stent of Example 1 being gradually released from the sheath tube uniformly;
  • 4-2 is a schematic view showing a sudden change of the coil expansion when the stent of the prior art is released;
  • Figure 5-1 is a schematic view showing the peak of the small curved side when the bracket having the connection point B on the small curved side is bent;
  • Figure 5-2 is a schematic structural view of the stent of the embodiment 2;
  • Figure 5-3 is a schematic view showing the height and angle of the eversion angle of the stent of the embodiment 2;
  • Figure 5-4 is a cross-sectional view of the stent of the embodiment 2;
  • 5-5 is a schematic view showing that the peak of the small curved side is not tilted when the stent of the second embodiment is bent;
  • 6-1 is a schematic structural view of a bracket of Embodiment 3;
  • 6-2 is a schematic exploded view showing the stent of the embodiment 3 after being cut along the axial direction;
  • 6-3 is a schematic exploded view showing the stent-mounted branch stent of the embodiment 3;
  • FIG. 7-1 is a schematic structural view of a stent of Embodiment 4.
  • FIG. 7-2 is an enlarged schematic view showing a BC connection point of the stent of Embodiment 4.
  • FIG. 7-3 is a schematic view showing the effect of adherence of the stent of Embodiment 4.
  • Figure 7-4 is a schematic view showing the height of the eversion angle of the stent of the embodiment 4.
  • 8-1 is a schematic structural view of a stent graft of Embodiment 5.
  • FIG. 8-2 is a schematic view showing the swinging effect of the stent graft of the embodiment 5;
  • 8-3 is a schematic view showing the effect of the prior art stent in generating a bird's beak in the anchoring zone;
  • 9-1 is a schematic structural view of a chimney bracket of Embodiment 6;
  • 9-2 is a partial enlarged schematic view of the chimney bracket of Embodiment 6;
  • 10-1 is a schematic structural view of a chimney bracket of Embodiment 7;
  • Fig. 10-2 is a partially enlarged schematic view showing the chimney holder of the seventh embodiment.
  • the blood vessel stent provided by the present invention in a natural state, in a group of two adjacent wave coils, a part of the peak of the lower layer coil is constrained to a part of the valley of the upper layer coil, and another part of the wave of the lower layer circle passes through the upper layer. Another portion of the wave crest and the other portion of the crest are non-contactly connected to the trough.
  • the wave height and the arrangement of the two connection modes can be adjusted in the design:
  • the distance between the peak apex of the lower layer coil and the valley apex of the upper layer circle determines the relatively distant range between the adjacent two coils, that is, the connection point is increased by adjusting the height of the peak
  • the distance between the peaks of the crests and the vertices of the troughs can effectively increase the degree of freedom between the support coils, which improves the flexibility.
  • connection point A of the restraint connection determines the length and appearance of the bracket in the natural state.
  • connection point B of the non-contact inter-connected connection provides a relatively distant space for the crest/valley, which defines the extent to which the bracket is elongated, and the crests/valleys on the large curved side of the bracket are non-contact inter-connected.
  • the stent design focuses on stability and elongation, the proportion of the number of joints A in the circumferential direction can be appropriately increased, and the joint point B can be used to improve the flexibility at a critical position where flexibility is required.
  • the stent is designed for the location of lesions in complex blood vessels and tortuous anatomical shapes, the stent needs to have better flexibility.
  • the distribution ratio of the connection point B can be increased, and only the connection point A is used at the critical point where force is required. Control of stent shape.
  • the corrugations of the blood vessel stent of the present invention are connected to each other, the waveform is limited, and the range of relative displacement between the coils is limited.
  • the constraint between the coils acts to shape the waveform inside the sheath.
  • the variation is evenly transmitted to the sheath to be sheathed outside the sheath tube, and can be more easily and orderly inserted into the sheath tube than the prior art blood vessel stent, thereby avoiding the waveform eversion and even the stent shape due to the extrusion and dragging during assembly. The destruction.
  • the vascular stent of the present invention can maintain a good shape, and is gradually released from the sheath uniformly, without causing a swelling mutation of the coil. Avoid damage to the vessel wall.
  • the blood vessel stent of the embodiment is a bare stent 100 having a braided mesh tubular structure, and includes a plurality of coils arranged in the axial direction by braiding nickel-titanium wires.
  • Each wave circle includes a plurality of circumferentially arranged waveforms, each waveform comprising a plurality of alternately arranged peaks and troughs. In the adjacent two wave circles, the peak of the lower wave circle is opposite to the wave valley of the upper wave circle. All the troughs of the same wave circle are circumferentially aligned, that is, the vertices of all the troughs of the same wave circle are located on a ring coaxial with the axis of the bare support.
  • the peaks of the same wave circle are different in height, and the different peak positions in the lower wave circle and the upper wave circle are realized by the peaks of different heights.
  • the positional relationship may be a peak/trough of the constrained connection peak/valley (corresponding to the connection point A shown in FIG. 3-1) and the non-contact inter-connected connection (ie, inter-connected and not in contact with each other in a natural state). (corresponds to the connection point B shown in Figure 3-1).
  • connection point A means that in the natural state, the apex of the upper layer wave is in contact with the peak apex of the lower layer circle, and the connection point B refers to the peak of the upper layer wave circle passing through the lower layer wave in the natural state, and the upper layer
  • the wave valley apex of the wave circle and the peak apex of the lower wave circle are separated by a distance.
  • the peaks/troughs of the constrained connection corresponding to the connection point A can be connected in various ways, for example, the peak of the lower layer coil can pass through the trough of the upper layer coil, and the vertices of the two are directly in contact but are movably connected, ie When the bare bracket is compressed in the axial direction, the peaks of the upper wave circle and the peaks of the lower wave circle can be relatively moved to a distance of one end but the axial compression force is cancelled, and the peaks of the upper layer wave and the peak of the lower layer wave return to both.
  • the valleys of the upper layer coil corresponding to the connection point A can also be directly and fixedly connected with the peaks of the lower layer coil, that is, the bare bracket is compressed in the axial direction, and the peaks of the upper layer wave circle and the lower layer wave circle do not occur relative to each other. motion.
  • the troughs of the upper layer coil corresponding to the connection point A may also be fixedly connected to the peaks of the lower layer coil by the connecting member.
  • the active connection between the trough of the upper layer coil corresponding to the connection point A and the peak of the lower layer coil can realize the connection between the upper layer coil and the lower layer coil of the bracket.
  • the ability of the coils to be axially close to each other when subjected to axial compression, when the bracket is bent and the joint point A is located on the small curved side of the bracket, between the coils Being close to each other can improve the overall flexibility of the stent.
  • connection point B corresponds to the peak/valley of the non-contact inter-connected connection, and the peak of the lower layer coil passes through the trough of the upper layer wave when weaving, and the peak of the upper layer circle and the peak of the lower layer circle are separated by a distance.
  • the distance L2 between the peak apex of the non-contact-connected lower layer wave and the valley apex of the upper layer coil is preferably 1/4 to 1/3 of the waveform height L1 of the upper layer coil.
  • the waveforms of the upper layer and the lower layer of the connected mode can be axially close to each other and away from each other within a distance L2 between the peaks of the peaks of the contactless lower waves and the valleys of the upper waves.
  • the bracket is more flexible.
  • the wave of the upper layer coil and the peak of the lower layer coil can move to contact each other and form a restraint to prevent further collapse of the stent shape.
  • Figure 3-3 taking two of the coils as an example, when the bracket is subjected to axial tensile stress, the waveforms of the upper and lower coils using the connection point A cannot move, and the upper wave of the connection point B is used. The waveforms of the circle and the lower layer are close to each other, and finally contact and limit the elongation of the bracket.
  • the axial length H of the bracket is stretched to H2, and the stent elongation (H2-H) is generally less than or equal to the case without considering the waveform deformation.
  • the range of relative displacement between the woven bare stents is limited.
  • the constraint between the coils acts to uniformly transmit the morphological changes in the sheath to the outside of the sheath.
  • the waveform is more easily and orderly loaded into the sheath than the bare bracket with a floating waveform/trough relationship between the coils, avoiding the waveform caused by the extrusion and dragging during assembly as shown in Figure 2-2.
  • the eversion is even the destruction of the stent shape.
  • the delivery system reaches the designated position and the stent is slowly released from the sheath, the bare stent can maintain a good shape and is gradually released from the sheath (Fig. 4-1) without being too free.
  • the inter-wave circle constraint causes a sudden change in the expansion of the coil at the time of release (Fig. 4-2), thereby causing damage to the vessel wall.
  • connection point A of the constrained connection of the bare bracket of the embodiment is uniformly distributed three times in the circumferential direction, and the connection point A is arranged in a spiral shape in the axial direction as shown in FIG. 3-2, and the remaining waveforms all adopt the connection point B of the non-contact type interconnection connection.
  • the multi-layer wave ring bracket formed by the arrangement provides axial tensile strength by the connection point of the constrained connection, the structure is stable, the axial elongation is low, and at the same time, the space is partially shortened, and the mutual proximity between the coils can be Providing a degree of flexibility, the axially arranged connection point A eliminates the directionality of the overall physical properties of the support; the connection point B of the non-contact inter-connected connection allows the peak/trough of the connection to be in a natural state In a state of relative freedom and non-interference, the wave circle has a certain displacement/deformation space in the axial direction, and can be relatively far away or relatively close, so that the compliance of the bracket is further improved.
  • the waveforms connected by the connection point B method have higher peaks of the lower layer. If the waveform connected by the connection point B is located on the small curved side of the bracket, see Figure 5-1. After the curved blood vessels are implanted, the bracket will be small. When the curved side is curved, the waveforms of the adjacent two wave circles will be mutually displaced/twisted, resulting in a higher peak in the lower layer of the coil, that is, not attached to the blood vessel wall, which may cause a certain risk of scraping the retraction of the conveying system, possibly The waveform is displaced due to the collision between the delivery system and the wave circle, and the peak of the lift will have a certain influence on the hemodynamics.
  • connection point B which is partially located on the small curved side of the bracket is optimized, so that the peak in the connection point B has an apex angled portion of the valgus angle ⁇ , FIG. 5-2),
  • the angle ⁇ is from 20° to 30°
  • the height L3 of the vertex-folding portion along the axial direction of the bare bracket is less than or equal to the peak of the peak of the non-contact inter-connected coil in the connection point B and the valley of the upper layer.
  • the distance between the vertices is more suitable for L2 (Fig. 5-3), and the connection point B after the eversion is simply referred to as the connection point B'.
  • each of the coils is composed of 15 peaks/valleys, and the adjacent two coils are connected in the same manner as in the first embodiment, and the four connection points B of the bracket facing the small curved side are subjected to the eversion predetermined type processing. , forming a connection point B' (Fig. 5-4).
  • the connection point B' effectively dissolves the protrusion of the peak caused by the original connection point B (Fig. 5-5), so that the attachment effect on the small curved side of the bracket is better, and the conveyor system is prevented from scratching the bare bracket. Risk of displacement/deformation/folding.
  • connection point B' is set on the large curved side of the bracket, the angle of the eversion of the protrusion and the wall of the blood vessel will not fit together, which will result in a decrease in the adherence of the large curved side of the bracket, and the predetermined portion of the protrusion will be It causes certain stimulation and even damage to the blood vessel wall, so the number and position of the connection point B' need to be rationally designed according to the design goal of the stent.
  • more connection point B' structures can be used on the small curved side of the stent.
  • the bare stent of the present embodiment provides an easy to operate solution for intraoperative window opening and placement of a branch bracket.
  • the waveform of one side of the bare stent relative to the branch vessel is adjusted, and on the basis of controlling the shape and elongation of the stent at the connection point A, in the area where window opening is required, Replace the corresponding connection point B with 2-4 floating F (the peak/valley of the upper and lower circles floating between each other) ( Figure 6-2 replaces 4 connection points as an example), and the replacement quantity is used by the bracket.
  • the size of the site and the diameter of the branch vessel are adjusted accordingly. The larger the diameter of the branch vessel, the more the connection point B needs to be replaced.
  • connection point A ensures the basic posture and lower extension of the bracket. Rate, connection point B and floating space F provide better flexibility for the bracket.
  • the part of the waveform structure is adjusted because of the floating F, so that the distance between the waveforms can be separated more on the original basis.
  • the branch bracket conveyor can easily pass through the suspended area formed by the floating space F, and at the same time, because the floating space F has a large degree of freedom and the waveform is unrestricted, the release is released.
  • the hanging region of the branching bracket in the floating space F is not subjected to a large rebounding force from the aortic stent waveform, and the blood flow of the branch vessel is ensured.
  • the bare stent (Fig. 7-1) of the present embodiment is a stent-limited woven bare stent for extending the proximal anchorage region of the aortic stent, and the coil includes 15 crests/valleys, upper coils.
  • the connection between the lower and the lower wave coils is as follows: 6 peaks/valleys of each adjacent two coils on the small curved side of the bracket are constrained by mutually constrained connection points A, and the remaining peaks/valleys are connected by non-contact interconnection.
  • the connection mode is connected, in which the three peaks/valleys (connection point C) on the large curved side have a large overlapping area (L4 in Fig.
  • connection point B there are three peaks/valleys (connection point B) on each side.
  • the overlapping points of the peaks and troughs corresponding to the connection points of the non-contact type interconnection of the present embodiment have different heights (B and C in FIG. 7-1), so that the bracket meets the compliance.
  • the adherence is further improved.
  • the inner wall of the stent does not produce excessive peaks/valleys, the small curved side is smooth, and the large curved side is fully open. Can be completely attached ( Figure 7-3).
  • the height of the overlap between the connection point B and the connection point C can be implemented in various forms, including but not limited to: 1 adjusting the height of the peak corresponding to the connection point; 2 adjusting the height of the valley corresponding to the connection point; 3 simultaneously adjusting the peak corresponding to the connection point And the height of the corresponding trough.
  • the peak of the small curved side may have the apex angle of the valgus angle ⁇ in the manner of Embodiment 2, so as to reduce the risk of the peak/trough of the inner wall of the scraping bracket of the conveying system.
  • the bracket adopts the form 2 or 3 to realize the dashed connection of the adjacent two corrugations, the crests and troughs can simultaneously have the apex angled portion of the eversion angle ⁇ (Fig. 7-4), and the vertex angle folding portion is bare
  • the height L4 of the bracket axial direction is in principle the same as in the second embodiment.
  • connection point B and the connection point C in this embodiment can be specifically adjusted according to the specific use environment of the support.
  • the present embodiment is a stent graft for the aorta.
  • the proximal end of the stent has two bare stent coils for extending the anchoring zone, and the lower layer coil is composed of a plurality of waveforms of unequal height ( It consists of a crest, a trough, and a rod connecting adjacent crests and troughs. It is circumferentially arranged and stitched to the inside of the stent.
  • the upper wave consists of multiple contours (including peaks, troughs, and adjacent peaks and troughs).
  • the rod body is constructed and connected to the lower layer coil by the crest/valley (connection point A) of the constrained connection and the peak/valley (connection point B) of the non-contact inter-connected connection.
  • the proximal stent of the stent graft of this embodiment has a certain swinging ability (see Fig. 8-2), and can better adhere and anchor under the anatomy of a certain angle of the blood vessel, thereby effectively avoiding the anchorage zone. A bird's beak caused by an excessive angle ( Figure 8-3).
  • this embodiment is a chimney holder for branching blood vessels and for use with an aortic stent graft.
  • the chimney bracket is a double-layer self-expanding stent graft having a double layer structure of inner layer and outer layer.
  • the inner layer bracket is composed of an inner membrane a, a metal bracket b and an outer membrane c.
  • the inner membrane a is an integral coating covering the inner wall of the metal bracket b, and the outer membrane c is a segmental coating, and the segmented coating is only covered by
  • the metal bracket b exposes the joint between the coils on the outer wall of the waveform of each wave circle; the metal bracket b is composed of a plurality of coils woven by nickel-titanium wire, so that the stent can conform to the opening of the aorta and the branch vessel
  • the angle, smooth and better adherence, the connection between the bracket coils is a combination of the crest/valley (connection point A) of the constrained connection and the crest/valley (connection point B) of the non-contact inter-connected connection
  • connection point A connection point
  • connection point B connection point
  • connection point A is spiraled in the axial direction (Fig. 9-2).
  • the entire bracket is connected. Because the inner layer of the stent has a coating of the inner and outer layers, the metal stent connection point is minimized, and the ability of the stent to conform to the blood vessel is maximized.
  • the stent of the present embodiment is based on the embodiment 6, and all the connection points B have a vertex angled portion of the valgus angle ⁇ (Fig. 10-1), and the stent is reinforced on the blood vessel wall by the connection point of each projection.
  • the anchoring force ( Figure 10-2) enhances the stent's ability to resist displacement.

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Abstract

一种血管支架（100），包括多个沿轴向排布的波圈，在自然状态下，在一组相邻的两个所述波圈中，下层波圈的部分波峰与上层波圈的部分波谷约束连接，下层波圈的另一部分波峰穿过上层波圈的另一部分波谷且该另一部分波峰与波谷非接触式互挂。该血管支架（100）的部分波峰和波谷采用一个或多个非接触式互挂连接，替代部分约束连接，在给予支架最大限度柔顺性的同时保证其整体稳定性。该支架（100）在装配及释放过程中均能保证良好的形态，保障了释放安全性。

Description

血管支架 技术领域
本发明涉及介入医疗器械技术领域，特别是涉及一种血管支架。
背景技术
自膨式血管裸支架多分为镍钛管切割支架与镍钛丝编织支架两种。其中，镍钛丝编织支架在顺应血管解剖形态时需要具有较好的柔顺性。对应地，参见图1，要求编织支架植入血管后波圈间至少部分的相对位置可以在一范围内发生变化。为实现这一形态变化要求，裸支架可具有如图2-1所示结构：一个波圈中的至少两个相互隔开的波峰和与该波圈相邻的另一个波圈中的至少两个相互隔开的波谷固定连接形成连接点A；该两个波圈中其余的波峰与波谷悬空，互不相连。该裸支架植入后能较好地贴合血管壁，但相邻两波圈中未相互连接的波峰和波谷容易发生如图2-2所示的过度形变，导致支架结构稳定性差。同时在支架装配过程中，会因为波圈间相互约束点较少，导致支架形态无法很好的控制，装配有一定难度；在释放时，波圈中未相互连接的波峰与波谷过度自由，也会导致支架在出鞘管的过程中无法保持形态，严重时甚至影响支架释放，或对血管壁造成损伤。
通过调整连接点A和悬空F的比例及排列组合方式，可对支架稳定性和柔顺性进行调整。连接点A越多，支架越稳定，同时柔顺性下降，反之支架柔顺性提升，稳定性下降。但并不能使支架既能拥有稳定、不易被破坏的形态，同时又能满足复杂多变的血管解剖形态以及安全可靠的释放性能。
发明内容
本发明提供一种血管支架，包括多个沿轴向排布的波圈，在自然状态下，在一组相邻的两个所述波圈中，下层波圈的部分波峰与上层波圈的部分波谷约束连接，下层波圈的另一部分波峰穿过上层波圈的另一部分波谷且该另一部分波峰与波谷非接触式互挂。所述非 接触式互挂是指在自然状态下，下层波圈的波峰与上层波圈的波谷互穿，且该波峰的顶点与该波谷的顶点具有一定距离，当且仅当支架受轴向拉伸时，该波谷和波峰相互接触且相互制约，限定支架的伸长长度。
每个所述波圈由多个周向排列的波形构成；所述波形包括波峰、波谷以及连接相邻所述波峰与波谷的杆体。同一波圈的波谷周向对齐，波峰高低不一，通过不同高度的波峰，实现与上层波圈对应波谷的不同位置关系，分别为约束连接的波峰/波谷A和非接触式互挂(互挂且在自然状态下不互相接触)的波峰/波谷B。
在一实施例中，所述与波谷非接触式互挂的波峰位于所述血管支架的小弯侧区，且具有外翻α角的顶角翻折部。采用非接触式互挂连接的连接点B方式的波形，下层波圈的波峰较高，导致当支架弯曲，该侧位于小弯侧时，波形的相互位移/扭转导致较高的波峰翘起，对输送系统器同的回撤造成一定的刮蹭风险，可能会因输送系统和波圈的碰撞导致波形的移位，同时翘起的波峰会对血流动力学造成一定的影响。当支架在预定位置释放后，采用外翻α角的顶角翻折部可以有效化解波峰的突起，使支架小弯侧的贴壁效果更好，降低输送系统对裸支架刮碰造成移位/变形/翻折的风险。
但是当外翻α角的顶角翻折部出现在支架大弯侧时，突起的顶角翻折部与血管壁将无法贴合，将会导致支架大弯侧贴壁性下降，且当支架相对血管较大时，突起的顶角翻折部会对血管壁造成一定的刺激，甚至损伤，所以顶角翻折部的分布数量及位置需要根据支架设计目标进行合理的设计。当支架需要克服复杂多变的血管结构环境时，可更多的使用顶角翻折部来优化支架的小弯侧。
在一实施例中，在另一组相邻的两个所述波圈中，下层波圈的部分波峰与上层波圈的部分波谷约束连接，下层波圈的另一部分波峰与上层波圈的另一部分波谷皆悬空。在支架相对分支血管的一侧波形设置悬空，可以为术中开窗并放入分支支架提供操作简单的解决方案。
在一实施例中，在一组相邻的两个所述波圈中，下层波圈的波峰与上层波圈的波谷除了一部分约束连接和一部分呈所述非接触式互挂外，还包括皆悬空的波峰和波谷。例如该血管支架可以是主动脉弓术中支架，或需在周面原位开窗后与分支支架配合使用的血管支架
在一实施例中，所述至少两组非接触式互挂的波峰顶点与波谷顶点之间的距离不相等。这样使得支架在满足顺应主动脉夹角的同时，贴壁性也进一步提高；支架在顺应主动脉夹角的同时，支架内壁不会产生过多翘起的波峰/波谷，小弯侧平滑，大弯侧张开充分并能完全贴壁。
在一实施例中，在自然状态下，所述非接触式互挂的下层波圈的波峰顶点与上层波圈的波谷顶点之间的距离为上层波圈的波形高度的1/4～1/3。采用该方式连接的上、下层波圈的波形可以在一定范围内实现轴向的相互靠近及远离，令支架柔顺性大大提升；同时当该区域出现明显的扩张形变时，上层波圈的波谷与下层波圈的波峰接触而形成束缚，限制波形并防止支架形态的进一步崩坏，以其中两个波圈为例，当支架受到轴向拉伸应力时，采用约束连接的连接点A的上层波圈和下层波圈的波形无法发生移动，采用非接触式互挂连接的连接点B的上层波圈和下层波圈的波形相互靠近，最终接触并限制支架进一步伸长，最终支架轴向长度H拉伸为H2，支架延伸率(H2-H)在不考虑波形形变的情况下一般小于或等于连接点B的非接触式互挂的下层波圈的波峰顶点与上层波圈的波谷顶点之间的距离L2。
在一实施例中，所述α角为20-30度。
在一实施例中，所述顶角翻折部沿所述血管支架轴向的高度≦所述非接触式互挂的下层波圈的波峰顶点与上层波圈的波谷顶点之间的距离。
在一实施例中，所述下层波圈的波谷位于与所述血管支架轴线同轴的圆环上，且与上层波圈非接触式互挂的下层波圈具有不同的波高。
在一实施例中，所述悬空的波峰和波谷各有2-4个。悬空的波峰和波谷的设置数量由使用支架的具体部位及分支血管直径的大小进行相应调整；分支血管的直径越大，需要设置的悬空的波峰和波谷就越多。
支架在释放时，约束连接保证了支架基本形态及较低的延伸率，非接触式互挂连接及悬空的波峰和波谷为支架提供了较好的柔顺性。在支架定位释放完成后，因具有悬空的波峰和波谷，使得波形间的距离在原来基础上可以更大的分离，为植入分支支架提供了空间。分支支架输送器可以轻松穿过悬空的波峰和波谷所在的区域，同时因悬空区域具有较大自由度、波形间互不限制的特性使得释放的分支支架在悬空区域不会受到来自主动脉支架波 形较大的回弹挤压力，保障分支血管血流的通畅。
在一实施例中，所述血管支架还包括覆膜支架段，所述多个波圈形成裸支架，所述裸支架与覆膜支架段的一端相连，例如该血管支架可以是腹主动脉覆膜支架。
在一实施例中，所述血管支架包括内层支架和外层支架，所述外层支架套设于所述内层支架外，且至少一端与所述内层支架的外表面密封连接；所述内层支架包括金属支架、覆盖于所述金属支架表面的覆膜，例如外层支架可以呈裙边状，一端密封连接在内层支架表面，另一端开口；还可以例如外层支架呈灯笼状，两端皆密封连接在内层支架表面。
在一实施例中，所述约束连接的连接点在所述血管支架的周向均布、且在轴向上的连线呈螺旋线。采用该排列方式形成的多层波圈支架由约束连接的连接点提供轴向拉伸强度，结构稳定，轴向延伸率低，同时有部分短缩的空间，通过波圈间的相互靠近可提供一定程度的柔顺性，在轴向上的连线呈螺旋线的连接点A消除支架整体物理性能的方向性；而非接触式互挂连接的连接点B可以使采用了该连接方式的波峰/波谷处于相对自由、互不干涉的状态，该状态下的波圈在轴向有一定位移/变形的空间，可以相对远离，亦可以相对靠近，使得支架柔顺性进一步提升。
在一实施例中，所述下层波圈的部分波峰与上层波圈的部分波谷固定连接形成所述约束连接；或者所述下层波圈的部分波峰穿过上层波圈的部分波谷且直接接触形成所述约束连接。采用上述方式连接，可在实现支架上、下层波圈连接的同时，使波圈间具备轴向相互靠近的能力，当该支架弯曲而该连接点位于小弯侧时，波圈间相互靠近可以提高支架整体的柔顺性。
在一实施例中，每个所述波圈具有8个波形。
本发明在编织支架上采用一个或多个非接触式互挂连接，替代部分约束连接，上层波圈的波谷和下层波圈的波峰在自然状态下互穿，只在支架拉长时两者的顶点才会接触，既可给予支架最大限度柔顺性又可保证其整体稳定性。该支架在装配及释放过程中均能保证良好的形态，保障了释放安全性。
附图说明
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是现有技术的镍钛丝编织支架植入血管后柔顺性示意图；
图2-1是现有技术有相互约束的波峰/波谷和悬空的波峰/波谷的裸支架的结构示意图；
图2-2是图2-1所示裸支架受力发生变形的示意图；
图3-1是实施例1的支架的结构示意图；
图3-2是实施例1的支架沿轴向剪开展开后的结构示意图；
图3-3是实施例1的支架受到拉伸应力的展开结构示意图；
图4-1是实施例1的支架均匀从鞘管中逐步释放的示意图；
图4-2是现有技术的支架在释放时波圈膨胀突变的示意图；
图5-1是小弯侧设有连接点B的支架弯曲时，小弯侧的波峰翘起的示意图；
图5-2是实施例2支架的结构示意图；
图5-3是实施例2支架的外翻α角的高度与角度的示意图；
图5-4是实施例2支架的横截面图；
图5-5是实施例2的支架弯曲时，小弯侧的波峰无翘起的示意图；
图6-1是实施例3的支架的结构示意图；
图6-2是实施例3支架沿轴向剪开后的展开结构示意图；
图6-3是实施例3的支架植入分支支架的展开结构示意图；
图7-1是实施例4的支架的结构示意图；
图7-2是实施例4的支架的BC连接点的放大示意图；
图7-3是实施例4的支架的贴壁效果示意图；
图7-4是实施例4支架的外翻α角的高度的示意图；
图8-1是实施例5的覆膜支架的结构示意图；
图8-2是实施例5的覆膜支架的摆动效果示意图；
图8-3是现有技术的支架在锚定区产生鸟嘴现象的效果示意图；
图9-1是实施例6的烟囱支架的结构示意图；
图9-2是实施例6的烟囱支架的局部放大示意图；
图10-1是实施例7的烟囱支架的结构示意图；
图10-2是实施例7的烟囱支架的局部放大示意图。
具体实施方式
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。
除非另有定义，本文所使用的所有的技术和科学术语属于本发明的技术领域的技术人员通常理解的含义相同。本文在说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
本发明提供的血管支架，在自然状态下，在一组相邻的两个波圈中，下层波圈的一部分波峰与上层波圈的一部分波谷约束连接，下层波圈的另一部分波峰穿过上层波圈的另一部分波谷且该另一部分波峰与波谷非接触式互挂连接。
根据支架适用症的不同，可在设计时对波高及两种连接方式的排列组合进行针对性的调整：
(1)非接触式互挂连接方式中，下层波圈的波峰顶点与上层波圈的波谷顶点的距离决定了相邻两波圈间相对远离的范围，即通过调整波峰的高度来增加连接点波峰顶点/波谷顶点间的距离，可有效提高支架波圈间的自由度，使得柔顺性得到提升。
(2)两种连接方式的排列组合方式并不唯一，支架轴向延伸率由约束连接的连接点A提供，它决定了支架在自然状态下的长度及外观。当支架发生弯曲变形时，波圈间发生相对位移及扭转，位于大弯侧的上层波圈和下层波圈的对应波峰/波谷会发生相对远离，而小弯侧的上层波圈和下层波圈的对应波峰/波谷会发生相对靠近，从而实现支架的柔顺性。在这种状态下，通过约束连接的连接点A连接的波峰/波谷因没有相互间相对远离的能力，当其位于大弯侧时，将直接限制支架弯曲的柔顺性。而非接触式互挂连接的连接点B因给波峰/波谷提供了一定的相对远离的空间，限定了支架被拉长的范围，当支架大弯侧的波峰/波谷均为非接触式互挂连接的连接点B时，柔顺性更好，但是当连接点B过多时，也易造成该区域延伸率变大。所以，支架设计着重考虑稳定性及延伸率时，可适当增加连接点A在周向分布数量的比例，而在需要体现柔顺性的关键位置采用连接点B提高柔顺性。而当支架被设计用于复杂血管、曲折解剖形态的病变位置时，需要支架拥有更好柔顺性，此时可以增加连接点B的分布比例，仅在需要受力的关键点采用连接点A进行支架形态的控制。
在装配时，本发明的血管支架的波圈间因互相连接，波形受到限制，波圈间相对位移的范围有限，逐步收入鞘管时，波圈间的约束发挥作用，使鞘管内波形的形态变化均匀传递到鞘管外待装鞘的波形，相比现有技术的血管支架能更轻松有序的装入鞘管内，避免因装配时的挤压和拖拽造成波形的外翻甚至支架形态的破坏。同理，当输送系统到达指定位置，将支架从鞘管中缓慢释放时，本发明的血管支架能够保持良好的形态，均匀的从鞘管中逐步释放，不会产生波圈的膨胀突变，从而避免对血管壁造成损伤。
实施例1
参见图3-1，本实施例的血管支架为裸支架100，呈编织网管状结构，包括由镍钛丝编织而成的沿轴向排布的多个波圈。每个波圈包括多个周向排列的波形，每个波形包括多个交替排布的波峰和波谷。相邻的两波圈中，下层波圈的波峰与上层波圈的波谷相对。同一波圈的所有波谷周向对齐，即同一波圈的所有波谷的顶点位于与裸支架轴线同轴的圆环上。同一波圈的波峰高低不一，通过不同高度的波峰，实现下层波圈与上层波圈中对应的波峰与波谷的不同位置关系。该位置关系可以分别为约束连接的波峰/波谷(对应于图3-1所示的连接点A)和非接触式互挂连接(即互挂且在自然状态下不互相接触)的波峰/波谷(对应于图3-1所示的连接点B)。所述连接点A是指在自然状态下上层波圈的波谷顶点与下层波圈的波峰顶点接触，连接点B是指在自然状态下上层波圈的波谷穿过下层波圈的波峰，且上层波圈的波谷顶点和下层波圈的波峰顶点之间相隔一段距离。其中，连接点A对应的约束连接的波峰/波谷可通过多种方式实现连接，例如，可以是下层波圈的波峰穿过上层波圈的波谷，且两者的顶点直接接触但活动连接，即沿轴向压缩裸支架时，上层波圈的波谷和下层波圈的波峰可以相对运动至隔开一端距离但撤销轴向压缩力后，上层波圈的波谷和下层波圈的波峰恢复至两者的顶点相互接触，连接点A对应的上层波圈的波谷也可以与下层波圈的波峰直接固定连接，即沿轴向压缩裸支架，上层波圈的波谷和下层波圈的波峰不会发生相对运动。在本发明其他实施例中，连接点A对应的上层波圈的波谷还可以通过连接件与下层波圈的波峰固定连接。
本实施例的裸支架中，参见图3-2，连接点A对应的上层波圈的波谷与下层波圈的波峰之间活动连接，可在实现支架上层波圈和下层波圈连接的同时，使波圈间在受到轴向压缩时具备轴向相互靠近的能力，当该支架弯曲而该连接点A位于支架的小弯侧时，波圈间 相互靠近可以提高支架整体的柔顺性。连接点B对应非接触式互挂连接的波峰/波谷，编织时使下层波圈的波峰穿过上层波圈的波谷，且上层波圈的波谷和下层波圈的波峰之间相隔一段距离，在连接点B处，非接触式互挂的下层波圈的波峰顶点与上层波圈的波谷顶点之间的距离L2为上层波圈的波形高度L1的1/4～1/3较为合适，采用该方式连接的上层波圈和下层波圈的波形可以在非接触式互挂的下层波圈的波峰顶点与上层波圈的波谷顶点之间的距离L2的范围内实现轴向的相互靠近及远离，令支架柔顺性大大提升。当连接点B对应的支架区域出现明显的扩张形变时，上层波圈的波谷和下层波圈的波峰可运动至相互接触，并形成束缚，防止支架形态的进一步崩坏。如图3-3，以其中两个波圈为例，当支架受到轴向拉伸应力时，采用连接点A的上层波圈和下层波圈的波形无法发生移动，采用连接点B的上层波圈和下层波圈的波形相互靠近，最终接触并限制支架进一步伸长，最终支架轴向长度H拉伸为H2，支架延伸率(H2-H)在不考虑波形形变的情况下一般小于或等于连接点B的下层波圈的波峰顶点与上层波圈的波谷顶点之间的距离L2。
在装配时，该编织裸支架波圈间相对位移的范围有限，当将裸支架收入鞘管时，波圈间的约束发挥作用，使鞘管内波形的形态变化均匀传递到鞘管外待装鞘的波形，相比起波圈间带有悬空波形/波谷关系的裸支架能更轻松有序的装入鞘管内，避免因装配时的挤压和拖拽造成波形发生如图2-2所示的外翻甚至支架形态的破坏。同理，当输送系统到达指定位置，将支架从鞘管中缓慢释放时，该裸支架能够保持良好的形态，均匀的从鞘管中逐步释放(图4-1)，不会因过于自由的波圈间约束导致释放时波圈的膨胀突变(图4-2)，从而对血管壁造成损伤。
本实施例的裸支架的约束连接的连接点A周向均布三个，同时在轴向上连接点A以螺旋状排列如图3-2，其余波形全部采用非接触式互挂连接的连接点B，采用该排列方式形成的多层波圈支架由约束连接的连接点提供轴向拉伸强度，结构稳定，轴向延伸率低，同时有部分短缩的空间，通过波圈间的相互靠近可提供一定程度的柔顺性，轴向螺旋状排列的连接点A消除支架整体物理性能的方向性；非接触式互挂连接的连接点B可以使采用了该连接方式的波峰/波谷在自然状态下处于相对自由、互不干涉的状态，该波圈在轴向有一定位移/变形的空间，可以相对远离，亦可以相对靠近，使得支架柔顺性进一步提升。
实施例2
采用连接点B方式互挂的波形，下层波圈波峰较高，若采用连接点B方式互连的波形位于支架小弯侧，参见图5-1，植入弯曲的血管后，支架会向小弯侧弯曲，相邻两波圈的波形会发生相互位移/扭转，导致下层波圈中较高的波峰翘起即不贴血管壁，对输送系统的回撤造成一定的刮蹭风险，可能会因输送系统和波圈的碰撞导致波形的移位，同时翘起的波峰会对血流动力学造成一定的影响。
本实施例在实施例1的基础上，对部分位于支架小弯侧的连接点B进行优化，使该连接点B中的波峰具有外翻α角的顶角翻折部图5-2)，α角为20°～30°时较为合适，顶角翻折部沿裸支架轴向的高度L3小于或等于连接点B中非接触式互挂的下层波圈的波峰顶点与上层波圈的波谷顶点之间的距离L2时较为合适(图5-3)，下文将外翻后的连接点B简称为连接点B'。本实施例中，每个波圈由15个波峰/波谷构成，相邻的两个波圈的连接方式与实施例一相同，支架面向小弯侧的四个连接点B采用外翻预定型处理，形成连接点B'(图5-4)。当支架在预定位置释放后，连接点B'有效化解原连接点B造成的波峰的突起(图5-5)，使支架小弯侧的贴壁效果更好，降低输送系统对裸支架刮碰造成移位/变形/翻折的风险。
值得一提的是，若在支架大弯侧设置连接点B'，突起的外翻α角与血管壁将无法贴合，将会导致支架大弯侧贴壁性下降，突起的预定型部分会对血管壁造成一定的刺激，甚至损伤，所以连接点B'的分布数量及位置需要根据支架设计目标进行合理的设计。当支架需要克服复杂多变的血管结构环境时，可在支架的小弯侧使用更多的连接点B'结构。
实施例3
本实施例的裸支架为术中开窗并放入分支支架提供了操作简单的解决方案。参见图6-1，在实施例1的基础上，将裸支架相对分支血管的一侧波形进行调整，在保留连接点A进行支架形态及延伸率的控制基础上，在需要开窗的区域，使用2-4个悬空F(上层波圈和下层波圈相互悬空的波峰/波谷)替换掉对应的连接点B(图6-2以替换4个连接点为例)，替换数量由支架具体使用部位及分支血管直径大小进行相应调整，分支血管直径越大，需要替换的连接点B就越多。该支架在释放时，连接点A保证了支架基本姿态及较低的延伸 率，连接点B及悬空F为支架提供了较好的柔顺性，在支架定位释放完成后，调整过波形结构的部分因为具有悬空F，使得波形间距离在原来基础上可以更大的分离，为植入分支支架提供了空间(图6-3)，分支支架输送器可以轻松穿过悬空F形成的悬空区域，同时因为悬空F具有较大自由度、波形间互不限制的特性使得释放的分支支架在悬空F产生的悬空区域不会受到来自主动脉支架波形较大的回弹挤压力，保证分支血管血流的通畅。
实施例4
本实施例的裸支架(图7-1)为主动脉限制性编织裸支架，用于延长主动脉支架近心端锚定区，该支架每个波圈包括15个波峰/波谷，上层波圈和下层波圈间连接方式为：支架小弯侧每相邻的两个波圈中有6个波峰/波谷采用相互约束的连接点A约束连接，其余波峰/波谷均由非接触式互挂连接的连接方式连接，其中大弯侧3个波峰/波谷(连接点C)互挂重叠区域较大(图7-2中的L4)，两侧各有3个波峰/波谷(连接点B)互挂重叠区域较小(图7-2中的L2)的波峰/波谷。不同于实施例1的是，本实施例的非接触式互挂连接的连接点对应的波峰和波谷的重叠区域具有不同的高度(图7-1中的B和C)，使支架在满足顺应主动脉夹角的同时，贴壁性也进一步提高，支架在顺应主动脉夹角的同时，支架内壁不会产生过多翘起的波峰/波谷，小弯侧平滑，大弯侧张开充分并能完全贴壁(图7-3)。
连接点B与连接点C的重叠高度可通过多种形式实现，包括但不限于：①调整连接点对应的波峰的高度；②调整连接点对应的波谷的高度；③同时调整连接点对应的波峰及对应波谷的高度。
对于适用于弯曲血管内的支架，可采用实施例2的方式使位于小弯侧的波峰具有外翻α角的顶角翻折部，以降低输送系统刮蹭支架内壁波峰/波谷的风险，当支架采用形式②或③来实现相邻两波圈的虚挂连接时，可同时使波峰和波谷具有外翻α角的顶角翻折部(图7-4)，顶角翻折部沿裸支架轴向的高度L4原则上与实施例2相同。
非等高连接点组合(本实施例为连接点B与连接点C的组合)的排列方式及位置可根据支架具体使用环境进行针对性调整。
实施例5
参见图8-1，本实施例为用于主动脉的覆膜支架，支架近端带有两个用于延长锚定区的裸支架波圈，下层波圈由多个不等高的波形(包括波峰、波谷、以及连接相邻波峰与波谷的杆体)周向排列构成，并缝合于支架覆膜内侧，上层波圈由多个等高波形(包括波峰、波谷、以及连接相邻波峰与波谷的杆体)构成，并通过约束连接的波峰/波谷(连接点A)，以及非接触式互挂连接的波峰/波谷(连接点B)与下层波圈相连接。该实施例的覆膜支架近端裸支架具有一定的摆动能力(参见图8-2)，能在有一定夹角的血管解剖形态下更好的贴壁并锚定，有效避免因锚定区夹角过大造成的鸟嘴现象(图8-3)。
实施例6
参见图9-1，本实施例为一款用于分支血管、并可以与主动脉覆膜支架配合使用的烟囱支架。该烟囱支架为双层自膨式覆膜支架，支架具有内层及外层双层结构。内层支架由内膜a、金属支架b和外膜c组成，内膜a为整体覆膜覆盖在金属支架b的内壁上，外膜c则为分段覆膜，分段覆膜仅覆盖于金属支架b每个波圈的波形的外壁上，将波圈间的连接部位露出；金属支架b由镍钛丝编织的多个波圈相连构成，为使支架能顺应主动脉与分支血管开口处的夹角，柔顺并较好的贴壁，支架波圈间的连接采用了约束连接的波峰/波谷(连接点A)与非接触式互挂连接的波峰/波谷(连接点B)组合的方式，每两个波圈间相互对应的波峰波谷周向分布2个连接点A，其余波峰波谷均以连接点B的方式连接，连接点A在轴向以螺旋的方式(图9-2)将整个支架连接起来。内层支架因为有内外层的覆膜，使得金属支架连接点减少到最低，令支架顺应血管的能力最大化。
实施例7
本实施例的支架在实施例6的基础上，所有连接点B具有外翻α角的顶角翻折部(图10-1)，通过每个凸起的连接点，增强支架在血管壁上的锚定力(图10-2)，增强支架抗移位的能力。
上面结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本领域的普通技术人员在 本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，这些均属于本发明的保护之内。

Claims (14)

  1. 一种血管支架，包括多个沿轴向排布的波圈，其特征在于，在自然状态下，在一组相邻的两个所述波圈中，下层波圈的部分波峰与上层波圈的部分波谷约束连接，下层波圈的另一部分波峰穿过上层波圈的另一部分波谷且该另一部分波峰与波谷非接触式互挂。
  2. 根据权利要求1所述的血管支架，其特征在于，所述与波谷非接触式互挂的波峰位于所述血管支架的小弯侧区，且具有外翻α角的顶角翻折部。
  3. 根据权利要求1所述的血管支架，其特征在于，在另一组相邻的两个所述波圈中，下层波圈的部分波峰与上层波圈的部分波谷约束连接，下层波圈的另一部分波峰与上层波圈的另一部分波谷皆悬空。
  4. 根据权利要求1所述的血管支架，其特征在于，该组相邻的两个所述波圈还包括皆悬空的波峰和波谷。
  5. 根据权利要求1所述的血管支架，其特征在于，所述至少两组非接触式互挂的波峰顶点与波谷顶点之间的距离不相等。
  6. 根据权利要求1-5任一项所述的血管支架，其特征在于，在自然状态下，所述非接触式互挂的下层波圈的波峰顶点与上层波圈的波谷顶点之间的距离为上层波圈的波形高度的1/4～1/3。
  7. 根据权利要求2所述的血管支架，其特征在于，所述α角为20-30度。
  8. 根据权利要求2所述的血管支架，其特征在于，所述顶角翻折部沿所述血管支架轴向的高度≦所述非接触式互挂的下层波圈的波峰顶点与上层波圈的波谷顶点之间的距离。
  9. 根据权利要求4所述的血管支架，其特征在于，所述下层波圈所有波谷的顶点位于与所述血管支架轴线同轴的圆环上，且与上层波圈非接触式互挂的下层波圈具有不同的波高。
  10. 根据权利要求3或4所述的血管支架，其特征在于，所述悬空的波峰和波谷各有2-4个。
  11. 根据权利要求1所述的血管支架，其特征在于，所述血管支架还包括覆膜支架段，所述多个波圈形成裸支架，所述裸支架与覆膜支架段的一端相连。
  12. 根据权利要求1或2所述的血管支架，其特征在于，所述血管支架包括内层支架和外层支架，所述外层支架套设于所述内层支架外，且至少一端与所述内层支架的外表面密封连接；所述内层支架包括金属支架和覆盖于所述金属支架表面的覆膜。
  13. 根据权利要求1所述的血管支架，其特征在于，所述约束连接的连接点在所述血管支架的周向均布、且在血管支架外表面上的连线呈螺旋线。
  14. 根据权利要求1所述的血管支架，其特征在于，所述下层波圈的部分波峰与上层波圈的部分波谷固定连接形成所述约束连接；或者所述下层波圈的部分波峰穿过上层波圈的部分波谷且直接接触形成所述约束连接。
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