CN104287870B - Intraluminal stent - Google Patents
Intraluminal stent Download PDFInfo
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- CN104287870B CN104287870B CN201410532215.8A CN201410532215A CN104287870B CN 104287870 B CN104287870 B CN 104287870B CN 201410532215 A CN201410532215 A CN 201410532215A CN 104287870 B CN104287870 B CN 104287870B
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Abstract
The invention discloses a kind of intraluminal stent, the overlay film frame section being connected including bare bracket section and with bare bracket section, bare bracket section includes at least two coaxial wavy annular things and rigid connector, bare bracket section also includes flexible couplings that are nonelastic and arbitrarily can bending, pass through rigid connector per two adjacent wavy annular things at least two wavy annular things and flexible couplings connect, rigid connector mixes arrangement with flexible couplings in the circumferential, and the length of flexible couplings is slightly larger than the shortest spacing between two wavy annular things.The present invention provides a kind of intraluminal stent that can be improved support compliance and keep support axial direction bonding strength.
Description
Technical field
The invention belongs to technical field of medical instruments, is related to a kind of intraluminal support, more particularly to it is a kind of for actively
Intraluminal stent in arteries and veins.
Background technology
In arotic disease, mainly include two class disease of dissection of aorta and aortic aneurysm；Aortic aneurysm further divides
For aorta true aneurysm and aortic pseudoaneurysm.Aortic aneurysm and dissection of aorta are a kind of extremely dangerous diseases
Disease, the mortality rate after morbidity in 48 hours are more than 50%, and the mortality rate in two weeks is more than 85%, have seriously threatened the mankind to be good for
Health.With the arrival of Chinese aging trend, its sickness rate constantly will rise.
In aortic aneurysm patient, abdominal aortic aneurysms account for the 63%～79% of aortic aneurysm prevalence, and multiple
Be born in the elderly population of more than 60 years old, up to 2%～4%, male is more than women to sickness rate, it is all cause death the reason in arrange
At the 13rd.As shown in Fig. 1 a, 1b, most of abdominal aortic aneurysms 4 are, caused by atherosclerosiss, to be normally at renal artery 2
Distal end (in implantation field, generally define blood and proximally flow to distal end, blood is flowed to as shown in arrow in Fig. 1 a, 1b), prolong
Extend at abdominal aortic bifurcation, ordinary wave and iliac artery 5, renal artery 2 is located at once in a while with upper bit；Once patient's abdominal aortic aneurysm 4
Rupture, mortality rate up to 50%～80%, is a kind of and its dangerous disease, so intervention is carried out before rupture of abdominal aorta
Treatment tool is of great significance.
During Minimally Interventional Therapy arotic disease, inner cavity insulation principle, i.e. EVAR are generally utilized
(endovascular aneurysm repair, EVAR), using overlay film frame isolation blood flow and aortic aneurysm or aorta clamp
Layer.Aorta tectorial membrane stent in the industry is mainly by the PET (polyethylene terephthalate of tinsel and cover it at present
Resin) film or ePTFE (politef) film composition, tinsel makes cylinder-shaped bracket skeleton, cover thereon PET film or
EPTFE membrane.
Most of intraluminal stents for treating aortic aneurysm are included overlay film frame section and are connected with the overlay film frame section
Connected bare bracket section, overlay film frame section are used to completely cut off blood flow and aortic aneurysm or dissection of aorta, and bare bracket section is used to improve
The support grappling performance of the adherence quality and aorta vessel overlay film frame near-end of mount proximal end, prevent overlay film frame section displacement and
In mount proximal end art, postoperative I types internal hemorrhage due to trauma, for for ventral aorta support for, bare bracket section can avoid simultaneously cut-out flow
Enter the blood flow of renal artery.
As shown in Fig. 1 a, 1b by taking abdominal aortic aneurysm as an example, Fig. 1 a are the preferable situation of proximal landing zone form, Fig. 1 b are near
The poor situation of end anchorage zone form, EVAR operations have certain requirement to proximal landing zone form, it is desirable to near-end tumor neck length degree H
(referring to the Normal aorta segment length between tumor body near-end and nearlyer renal artery) >=15mm, now due to the improvement of support and skill
Near-end tumor neck length degree can be loosened to H >=10mm by the raising of art；Tumor neck angle [alpha] on near-end kidney (refer to near-end tumor neck axis with
Angle between ventral aorta trunk axis on kidney)≤60 ° are answered, under kidney, tumor neck angle beta is (in referring to near-end tumor neck axis and tumor chamber
Angle between axis) answer≤70 °.Tumor neck is shorter, is available for the region of overlay film frame grappling less, in art, postoperative generation near-end I
The probability of the complication such as type internal hemorrhage due to trauma, graft displacement is higher.Tumor neck angle is bigger, it is necessary to which the better support of compliance is fitting
Should.A kind of technology for solving in the industry this problem at present is across the renal artery technology of near-end bare bracket, by the near of overlay film frame blood vessel
Across the renal artery release of end bare bracket, applicable bare bracket to be divided into and pierce bare bracket without anchor and pierce two class of bare bracket with anchor.Without anchor
Thorn bare bracket mostly is individual pen wavy annular thing, and in cylinder or bell mouth shape, clinic is mainly used in near-end tumor neck length degree and is more than
15mm, tumor neck form rule can be which provides the situation of one good touchdown area, but such bare bracket only leans on circumference because of which
Active force is fitted with blood vessel, has the shortcomings that anchoring properties difference, is still easier shifting occur in operation process or postoperative period
Position phenomenon.
The case of (between 10mm ＜ H ＜ 14mm) shorter for tumor neck, is generally carried out using band anchor thorn bare bracket solid on kidney
Fixed, anchor thorn structure is penetrated in blood vessel wall, and what is can consolidated fixes support, the displacement for preventing support at a specified future date, and this kind of design is less
The subject range that bare bracket has widened abdominal aortic aneurysm intracavitary therapy is pierced with anchor.Band anchor thorn bare bracket constitutes structure substantially according to which
Individual pen structure and many coil structures (generally two circles in the industry at present) can be divided into again, wherein individual pen structure is the ripple that a circle is provided with anchor thorn
Shape ring, is applied to clinical complicated bend vascular anatomy form, after support discharges, because its axial length it is shorter, bare bracket
Occur that a side anchor pierces excessive docile blood vessel wall, another side anchor thorn is separated and hanging state with blood vessel wall, so as to affect its anchor
Qualitative energy.
Many coil structures with multi-turn wavy annular thing can avoid the connection between disadvantages mentioned above, but adjacent waveform ring
New problem can then be brought, linked together by rigid connector between current adjacent turn wavy annular thing, such as it is adjacent
In wavy annular thing, the distal end summit of one of wavy annular thing is all connected with the proximal apices in another wavy annular thing
There is metal thin bar, this rigid connection increased the integrated connection rigidity of bare bracket, it is to avoid support cripetura, but cause which soft
Pliable poor problem, bare bracket are difficult the change for adapting to blood vessel angle, can apply larger for a long time to blood vessel wall after implantation
Stress, increases the probability of happening of complication.
The content of the invention
The technical problem to be solved in the present invention is, for defect above-mentioned in prior art, there is provided one kind can be improved props up
Frame compliance and keep support axial direction bonding strength intraluminal stent.
The technical solution adopted for the present invention to solve the technical problems is：A kind of intraluminal stent, including bare bracket section and with
The overlay film frame section that the bare bracket section is connected, the bare bracket section include that at least two coaxial wavy annular things and rigidity connect
Fitting, the bare bracket section also include flexible couplings that are nonelastic and arbitrarily can bending, at least two wavy annulars thing
In pass through the rigid connector and the flexible couplings per two adjacent wavy annular things and connect, in the circumferential it is described just
Property connector mix arrangement with the flexible couplings, the length of the flexible couplings is slightly larger than between two wavy annular things
Shortest spacing.
Each described wavy annular thing includes multiple continuous end to end supporting parts for forming waveform, all of support zone
On the same face of cylinder, with regard to axis axial symmetry arrange, multiple supporting part head and the tail junctions formed multiple proximal apices and
Multiple distal end summits；One proximal apices of a wavy annular thing in two adjacent wavy annular things and another waveform
One distal end summit of ring passes through rigid connector or flexible couplings connect.
At least two wavy annulars thing includes near-end wavy annular thing and distal end wavy annular thing, adjacent near-end ripple
Waveform phase between shape ring and distal end wavy annular thing is asynchronous；Or the ripple of near-end wavy annular thing is wider than distal end ripple
The ripple width of shape ring.
The rigid connector is staggered with the flexible couplings.
The structure that the wavy annular thing and the rigid connector are formed in one.
The rigid connector is obliquely installed relative to the axis of the bare bracket section, and positioned on the same face of cylinder
On.
The angle δ of the rigid connector circumference vertical with the bare bracket section axis is 20 °～45 °.
Each wavy annular thing is equipped with for fixing the connecting hole of the flexible couplings.
The flexible couplings have high tensile, and the compatible silk thread of human body for sub-thread；Or the soft company
Fitting is the blend of one or more silk thread Jing multiply blending.
The silk thread is made up of macromolecular material, and the macromolecular material includes in PE, PTFE, PET and PP at least one
Kind.
The wavy annular thing includes and hanging proximal apices of the connectionless least one set of adjacent waveform ring and/or extremely
Few one group of hanging distal end summit, per group of hanging proximal apices include 1 hanging proximal apices or 2 adjacent hanging near-end tops
Point, per group of hanging distal end summit include 1 hanging distal end summit or 2 adjacent hanging distal end summits.
The rigid connector in the axial direction of bare bracket section in the shape of a spiral or straight line arrangement；And/or the soft company
Fitting in the axial direction of bare bracket section in the shape of a spiral or straight line arrangement.
The proximal top of the bare bracket section is provided with anchor thorn, the distal end of the anchor thorn part towards bare bracket section.
In the intraluminal stent of the present invention, except being connected by rigid connector between the adjacent waveform ring of bare bracket section
Outward, also connected using flexible couplings.As flexible couplings are nonelastic, can arbitrarily bend, be rigidly connected and soft connection
And deposit, on the basis of meeting intraluminal stent axial tensile strength and preventing cripetura, the use of flexible couplings increased tube chamber
The bending compliance of support, while also ensuring that the bonding strength of the overall axial direction of support.
Description of the drawings
Below in conjunction with drawings and Examples, the invention will be further described, in accompanying drawing：
Kidney mo(u)ld bottom half abdominal aortic aneurysm schematic diagrams of Fig. 1 a for proximal landing zone form specification；
Fig. 1 b are the relatively nonstandard kidney mo(u)ld bottom half abdominal aortic aneurysm schematic diagram of proximal landing zone form of relative Fig. 1 a；
Fig. 2 is intraluminal stent structural representation of the present invention；
Fig. 3 is the structural representation of the first embodiment of bare bracket section；
Plane outspread drawings of the Fig. 4 for Fig. 3 bare bracket sections；
Fig. 5 a, 5b are the partial schematic diagram in Fig. 4；
Fig. 6 is the partial schematic diagram in Fig. 4；
Fig. 7 is discharged into the schematic diagram after ventral aorta for intraluminal stent in Fig. 2；
Fig. 8 is the bare bracket segment structure schematic diagram of second embodiment；
Plane outspread drawings of the Fig. 9 for Fig. 8 bare bracket sections；
Figure 10 is the partial schematic diagram in Fig. 9；
Figure 11 is bare bracket section and main body overlay film frame connection diagram in Fig. 9；
Figure 12 is discharged into the schematic diagram after ventral aorta for intraluminal stent in Figure 11；
Figure 13 is the structural representation of the third embodiment of bare bracket section；
Plane outspread drawings of the Figure 14 for Figure 13 embodiment bare brackets；
Structural representations of the Figure 15 for the 4th kind of embodiment of bare bracket section；
Plane outspread drawings of the Figure 16 for Figure 15 embodiment bare brackets.
Specific embodiment
In order to be more clearly understood to the technical characteristic of the present invention, purpose and effect, accompanying drawing is now compareed, with abdomen actively
Describe the specific embodiment of the present invention as a example by pulsation frame in detail.One of ordinary skill in the art is it is to be understood that abdomen master
Arterial bracket is used only as citing, not limitation of the present invention, and the intraluminal stent of the present invention is the arbitrary overlay film with bare bracket
Intraluminal stent, including but not limited to ventral aorta support, also including thoracic aorta support, iliac artery support etc..
Bearing definition：The present invention defines orientation, i.e. blood according to blood flow direction and proximally flows to distal end.
As shown in Fig. 2 a kind of intraluminal stent, including bare bracket section 10 and the overlay film frame section being connected with bare bracket section 10
20, bare bracket section 10 includes at least two coaxial wavy annular things 100 and rigid connector 130, and bare bracket section 10 also includes
Flexible couplings 131 that are nonelastic and arbitrarily can bending, per two adjacent wavy annulars at least two wavy annular things 100
Thing 100 passes through rigid connector 130 and flexible couplings 131 connect, in the circumferential rigid connector 130 and flexible couplings
131 mixing arrangements, the length of flexible couplings 131 is slightly larger than the shortest spacing between two wavy annular things 100.
As shown in Fig. 2 the overlay film frame section 20 in intraluminal stent includes overlay film 201 and metallic framework 202, metallic framework
202 can be made using biocompatible SIM (stress-induced martensite) alloy, and such as Nitinol, its shape may also be many
Individual axially arranged wavy annular thing, overlay film 201 is pasted through heat treatment or the mode that sutures is connected as one with metallic framework 202
Body.The concrete structure of overlay film frame section 20 is not different with other overlay film frame sections in prior art, be will not be described here.This reality
In applying example, metallic framework 202 is that titanium-nickel wire weaves or the sinusoidal wave form of NiTi pipe cutting sizing is axially arranged.Overlay film 201 is
PFFE (politef, Polytetrafluoroethylene) or PET (polyethylene terephthalate,
Polythylene terephthalate) material, paste through heat treatment or the mode that sutures is connected as with metallic framework 202
Integrally.
Bare bracket section 10 in intraluminal stent is arranged in 20 near-end of overlay film frame section, distal end and the overlay film of bare bracket section 10
The overlay film of 20 near-end of frame section is stitched together.Bare bracket section 10 includes at least two coaxial wavy annular things 100, wherein coaxially
Refer to and be all disposed within the axial direction of intraluminal stent in bare bracket section 10 and overlay film frame section 20, the two has a common axis
Line, at least two wavy annular things 100 of bare bracket section 10 are all symmetrical arranged with regard to the axis.These wavy annular things 100
With same or analogous waveform shape, for example, wavy annular thing 100 can be Z-shaped ripple, V-arrangement ripple or sine wave etc..Corrugated gasket
Shape thing 100, rigid connector 130 can be each separately formed, then linked together by modes such as welding, bondings, also may be used
Bare bracket section 10 is made with what wavy annular thing 100 and rigid connector 130 were formed in one, is integrally cut for example with NiTi pipe
Cut, and a bare bracket section 10 is formed through multistep thermal finalization using mould.Using the diameter of NiTi pipe can be according to concrete
Depending on the vessel diameter of placement location, such as NiTi pipe diameter is 5mm.
Each wavy annular thing 100 includes multiple continuous end to end supporting parts 112 for forming waveform, all of supporting part
112 are located on the same face of cylinder, arrange with regard to axis axial symmetry, i.e., wavy annular thing 100 forms cylindrical-shaped structure.It is multiple
112 head and the tail junction of supporting part forms multiple proximal apices and multiple distal end summits；During these proximal apices are whole waveform
Crest, distal end summit are the troughs in whole waveform.A wavy annular thing 100 in two adjacent wavy annular things 100
The distal end summit of a proximal apices and another wavy annular thing 100 pass through rigid connector 130 or soft connection
Part 131 connects.In the circumferential, rigid connector 130 and the mixing arrangement of flexible couplings 131, i.e. rigid connector 130 and soft
The arrangement of connector 131 is not concentrated setting, and rigid connector 130 and flexible couplings 131 on a certain position
Connection selects one, i.e., the position for being connected using rigid connector 130 will not reconnect flexible couplings 131, using soft company
Rigid connector 130 is selected to connect when the position of fitting 131 is different.So, in the circumferential in the middle of rigid connector 130 doped with
Flexible couplings 131, just the integrally bending rigidity of energy reduce rigidity connector 130, increases the compliance of intraluminal stent.
Rigid connector 130 refers to the connector with certain degree of hardness and bending compliance, and rigid connector 130 has simultaneously
There is the connector of support function and linkage function.The rigidity of rigid connector 130 can avoid support cripetura and provide support entirety
Bonding strength on axial direction, while also assures that intraluminal stent integrally has certain bending compliance.Flexible couplings 131 are
The deformation of nonelastic, tensionless winkler foundation, the connector that arbitrarily can be bent, therefore flexible couplings 131 mainly have connection constraints function, i.e.,
Effect of the proximal apices and distal end vertex to wavy annular thing 100 to constraint, in intraluminal stent BENDING PROCESS, due to soft
Property connector 131 length slightly larger than the shortest spacing between two wavy annular things 100, the constraint waveform of flexible couplings 131
Flexural deformation is complied with bending in the proximal apices of ring 100 and distal end summit, increased the soft of whole intraluminal stent
It is pliable, to avoid relatively sharp proximal apices and distal tip point from being pierced into blood vessel wall, damage is produced to blood vessel.
In the mixing arrangement of rigid connector 130 and flexible couplings 131 preferably in the circumferential rigid connector 130 with
Flexible couplings 131 are staggered.It is staggered to refer to regular doping flexible couplings 131 in rigid connector 130, example
Flexible couplings 131 are provided with if circumferentially-spaced one or more rigid connectors 130, flexible couplings 131 can be even
Continuous to arrange one or more, the continuous setting quantity of generally rigid connector 130 and flexible couplings 131 is not more than three, keeps away
Exempt from local stiffness too strong or rigid excessively weak.
Rigid connector 130 is column or rod-like structure on the whole, its shape can be it is various, for example linear, arc,
Shaped form etc., its cross sectional shape can be square or other irregular shapes without sharp corner after circular, oval, chamfering
Deng diameter or width is consistent with supporting part 112.The material of rigid connector 130 is biocompatibility metal, or other can be used
Make in the material of intraluminal stent.Preferred nickel/titanium alloy material in the present embodiment.
The waveform of each wavy annular thing 100 can be the same or different, and wave peak width can be the same or different,
Then so that the orientation setting of rigid connector 130 has difference relative to the axis of intraluminal stent, for example：It is flat relative to axis
Row is arranged, is obliquely installed relative to axis, and some of which rigid connector 130 is inclined relative to the axis of bare bracket section 10
Arrange, and positioned on the same face of cylinder.Rigid connector 130 is restricted relative to the incline direction of axis, is limited to
Incline on the same face of cylinder, rather than slope inwardly or outwardly.It is preferred that the angle of inclination of rigid connector 130 is：It is rigidly connected
The angle δ of the circumference vertical with 10 axis of bare bracket section of part 130 is 20 °～45 °.Relative to what is arranged parallel to axis
Rigid connector 130, more preferably, such as, when bracket bent, rigid connecting rod is such as 130 compliance of rigid connector being obliquely installed
Parallel to axis, then rigid connector 130 is by whole stress for fruit, and if relative tilt, then only can be attached at Bending Deformation
Nearly stress；In addition, rigid connector 130 is obliquely installed to coordinate forms helical arrangement in the axial direction, support is further improved
Overall bending compliance.
In the position being attached using flexible couplings 131, each wavy annular thing 100 is equipped with for fixing soft company
The connecting hole (such as connecting hole 116 and 123) of fitting 131.The position of connecting hole be wavy annular thing 100 proximal apices or
Distal end summit.
Flexible couplings 131 can adopt flexible flexible cord, flexible couplings 131 for sub-thread have high tensile,
The silk thread compatible with human body；Or flexible couplings 131 are the blend of one or more above-mentioned silk thread Jing multiply blending.It is above-mentioned
Silk thread can be made up of macromolecular material, and the material of such as flexible couplings 131 is (the poly- second of the PE with high tensile strength
Alkene, polyethylene), PTFE (politef, Polytetrafluoroethylene), PET (poly terephthalic acid second
Diol ester, Polythylene terephthalate), the suture of PP (polypropylene, Polypropylene) material or other
Medical suture and combinations thereof suture, can be sub-thread can also be the identical or different material blending of multiply blend.It is preferred that soft
Property connector 131 for various silk thread multiply blending blend, by test prove：Using blend relative to homogenous material,
With more reliable connection and tensile strength, it is particularly suited for the connection of bare bracket section 10 and knots fixing.Adopt in the present embodiment
Flexible couplings 131 are combined with PP sutures by super high molecular weight PE, and PE, PP suture adopts braiding structure, the combination
Suture is more smooth relative to other most polyester fibers and polyblend cross section, easily beats less knot, and beats
Knot is more solid, in addition with higher tensile strength.
The proximal top of bare bracket section 10 is provided with anchor thorn 114, and anchor pierces 114 distal ends towards bare bracket section 10.Specifically
Anchor is provided with the proximal apices of the wavy annular thing 100 of 10 near-end of bare bracket section pierces 114, Fig. 7 and show intraluminal stent and release
The schematic diagram being put into after ventral aorta 1, after release, the anchor thorn 114 of near-end wavy annular thing 110 is located at renal artery more than 2, its anchor
Thorn 114 is pierced in aortic blood tube wall, it is ensured that the reliable grappling of intraluminal stent near-end；Near-end wavy annular thing 110 and distal end are more
Circle ripple circle 120 is across renal artery, it is ensured that the normal supply of blood flow of renal artery；Overlay film is proximally located on the downside of renal artery.
As shown in Fig. 3-16, wavy annular thing 100 may include near-end wavy annular thing 110 and distal end wavy annular thing 120,
Waveform phase between adjacent near-end wavy annular thing 110 and distal end wavy annular thing 120 is asynchronous；Or near-end wavy annular
The ripple of thing 110 is wider than the ripple width of distal end wavy annular thing 120.Being arranged such can be beneficial to 130 relative axis of rigid connector
Incline (not parallel), so that the overall bending compliance of support is improved, be additionally favorable for rigid connector 130 and coordinate in the axial direction
Helical form is formed, the overall bending compliance of support is further improved.Certainly, it is illustrated that embodiment is used only as citing, near-end waveform
Ring 110 can be identical with the ripple width of distal end wavy annular thing 120, and waveform phase can be synchronous.
Below according to 100 arrangement mode of different wave ring in detail the embodiment party of multiple different bare bracket sections 10 is specifically described in detail
Formula：
The first embodiment：As shown in fig. 3 to 7, bare bracket section 10 includes two wavy annular things 100, respectively near-end
Wavy annular thing 110 and distal end wavy annular thing 120, wavy annular thing 100 can be Z-shaped ripple, V-arrangement ripple or sine wave etc..
As in Figure 3-5, the supporting part 112 of near-end wavy annular thing 110, it is end to end to form Z-shaped ripple, proximal apices
111a and distal end summit 111b, at proximal apices 111a, distal end summit 111b, transition forms circular arc 115a, a 115b respectively, far
Connecting hole 116 is set at endvertex.The present embodiment forms 6 Z waveform elements, as shown in Figure 5 a, waveform height h1 (proximal apices
Vertical dimension between 111a to distal end summit 111b) for 9mm.
As shown in Fig. 3,4,5a, 5b, proximally direction is extended with anchor thorn post 113 to proximal apices 111a, sets on anchor thorn post 113
It is equipped with the anchor integrally formed with anchor thorn post 113 and pierces 114, anchor thorn 114 is arranged is projected from anchor thorn post 113 near-end circumference, and extends
It is distally directed, formed and pierce 113 surface of post into angle γ with anchor, as shown in Figure 5 b, angle γ between 20 °～60 °, preferred angle
γ is 45 °, and anchor pierces 114 length between 2mm～5mm, preferred 3mm.During use, anchor thorn 114 can be pierced into Ink vessel transfusing, be pierced into position
Inner membrance can be climbed and be covered, and be capable of achieving mount proximal end in this way and reliably fix, it is to avoid with displacement at a specified future date in stenting.
Distal end wavy annular thing 120 is comprising proximal apices 121a, distal end summit 121b and in adjacent proximal apices 121a
And the supporting part 112 between the 121b of distal end summit.120 waveform number of distal end wavy annular thing is more than near-end wavy annular thing 110
Waveform number, is 9 waveforms, but it is of substantially equal to enclose the cylinder girth to be formed, therefore ripple width is reduced, waveform height and near-end ripple
Shape ring 110 is equal, is also 9mm.Connecting hole 123 is set at proximal apices 121a.
Near-end wavy annular thing 110 and distal end wavy annular thing 120 are to incline rigid connectors 130 by 3 and 3 soft
Property connector 131 links together, and flexible couplings 131 are fixed between connecting hole 116, connecting hole 123.As shown in fig. 6, just
Property the circumference vertical with 10 axis of bare bracket section of connector 130 angle δ be 20 °～45 °, in this example be 30 °.
As shown in Figure 3,4, sewing hole 124 is set, for by bare bracket at 120 distal end summit 121b of distal end wavy annular thing
Link together with 201 near-end of overlay film of intraluminal stent.
As shown in Fig. 2 overlay film frame section 20 includes overlay film 201 and metallic framework 202, metallic framework 202 is compiled for titanium-nickel wire
The sinusoidal wave form knitted, overlay film 201 is PFFE (politef, Polytetrafluoroethylene) or PET is (poly- right
PET, Polythylene terephthalate) material, paste through heat treatment or the mode that sutures connects
It is connected in one.
Fig. 7 show the schematic diagram after intraluminal stent is discharged into ventral aorta 1, near-end wavy annular thing 110 after release
Near on the upside of the renal artery 2, its anchor thorn 114 is pierced in the aortic blood tube walls on the upside of renal artery 2, it is ensured that intraluminal stent near-end can
The grappling leaned on；Near-end wavy annular thing 110 and distal end wavy annular thing 120 are across renal artery, it is ensured that the normal blood flow of renal artery
Supply；Overlay film frame section 20 is proximally located on the downside of renal artery.
Second embodiment of bare bracket section 10：Bare bracket section 10 adopt more than two wavy annular thing 100, i.e., one
Individual near-end wavy annular thing 110, two or more distal end wavy annular things 120.
110 structure of near-end wavy annular thing will not be described here with the first embodiment.
Relative to the first embodiment, the setting of multiple distal end wavy annular things 120 increased the whole of bare bracket section 10
Body draw ratio, has more preferable compliance, complies with more complicated tumor neck clip angle, while longer bare bracket segment length can make
Obtain near-end wavy annular thing 110 and enter into ventral aorta flat segments on kidney, more preferably, near-end grappling is more stable for adherence quality.Farthest
The distal end wavy annular thing 120 at end is stitched together with 201 position of intraluminal stent near-end overlay film.Wherein near-end wavy annular thing
110 can be arranged as required to, for example can be identical with 110 structures of near-end wavy annular thing in the first embodiment.
Fig. 9 show the planar development schematic diagram of the bare bracket section 10 of second embodiment.Multiple distal end wavy annulars
Thing 120 vertically parallel arrangement in the distal end of near-end wavy annular thing 110, waveform position either in phase with one another and ripple width is equal, this enforcement
6 distal end wavy annular things 120 are set in example, and 120 axial component of adjacent distal end wavy annular thing is overlapped, and is arranged in fish scale-shaped,
Waveform height is smaller than between the proximal apices of two i.e. adjacent wavy annular things 100 or distal end summit.Such as Figure 10 institutes
Show, overlap distance is that d is preferably 1/3～2/3 waveform height, in the present embodiment, overlap distance is that d is 1/2 waveform height.
In the present embodiment, each distal end wavy annular thing 120 is made up of 9 Z-shaped waveforms.Each waveform height is 8.0mm, former and later two
Between distal end wavy annular thing 120, overlap distance is 4mm.Two neighboring distal end wavy annular thing in distal end wavy annular thing 120
Pass through 3 rigid connectors 130 between 120 and 3 flexible flexible couplings 131 link together.Rigid connector 130 with
Support entirety cut is formed, and the blend that flexible flexible cord is combined using PE+PP, 131 connected mode of flexible couplings lead to
Cross connecting hole connection.
The setting linear in the axial direction of rigid connector 130 in this example between multiple distal end wavy annular things 120,
Rigid connector 130 i.e. between adjacent distal end wavy annular thing 120 is parallel to axis, and axially goes up adjacent rigidity and connect
Fitting 130 is arranged on the same line.As shown in figure 9, the flexible soft connection in this example between distal end wavy annular thing 120
The also linear setting of part 131.In the circumferential, rigid connector 130 and flexible couplings 131 are staggered, i.e., two rigidity
A flexible couplings 131 are provided between connector 130.
The connected mode of first distal end wavy annular thing 120 of near-end wavy annular thing 110 and near-end, with the first reality
The connected mode for applying near-end wavy annular thing 110 and distal end wavy annular thing 120 in mode is identical.In order to ensure near-end corrugated gasket
Axial bonding strength between shape thing 110 and distal end wavy annular thing 120, distal end wavy annular thing 120 are provided with and are rigidly connected
The proximal apices of part 130 are linked together by inclined rigid connector 130 with 110 distal end summit of near-end wavy annular thing,
Do not change the shape of 110 waveform of near-end wavy annular thing, and ensure that near-end wavy annular 110 waveforms of thing are circumferentially distributed uniform,
Rigid connector 130 is 30 ° with the angle of 10 axis of bare bracket section.
As shown in Fig. 8,9,11, the distal end wavy annular thing 120 of distalmost end can be with other distal end wavy annular things 120
Identical, or waveform number is identical, and waveform height is slightly higher.In the present embodiment, 120 ripple of distal end wavy annular thing of distalmost end
Shape is highly 9mm, and the 120 distal end apex of distal end wavy annular thing of distalmost end arranges sewing hole 124, for by bare bracket section 10
Link together with 20 near-end of overlay film of intraluminal stent.
Figure 12 show the schematic diagram after intraluminal stent is discharged into ventral aorta 1, after release, near-end wavy annular thing 110
Positioned at renal artery more than 2, its anchor thorn 214 is pierced in aortic blood tube wall, it is ensured that the reliable grappling of intraluminal stent near-end；Distal end ripple
Shape ring 120 is across renal artery 2, it is ensured that the normal supply of blood flow of renal artery；Overlay film frame section 20 is proximally located under renal artery
Side.
The third embodiment：As shown in Figure 13,14, the third embodiment is on the basis of second embodiment
Deformation, the arrangement mode of rigid connector 130 and flexible couplings 131 between multiple distal end wavy annular things 120 is carried out
Change.Each rigid connector 130 and flexible couplings 131 are parallel to axis, and rigid connector 130 is in bare bracket section 10
Axial direction in the shape of a spiral；And/or flexible couplings 131 in the axial direction of bare bracket section 10 in the shape of a spiral.
In present embodiment, between adjacent distal end wavy annular thing 120, pass through 3 rigid connectors 130 and 3 soft companies
Fitting 131 links together.Rigid connector 130 in this example between distal end wavy annular thing 120 axially twist,
Two rigid connectors 130 are spaced a waveform distance not on the same line, in the circumferential and arrange axially back and forth.Such row
Bending resistance in mode for cloth, when the bare bracket section 10 of near-end bends, between two neighboring wavy annular thing 100 on same axis
Power is further reduced compared with second embodiment, can further improve the compliance of intraluminal stent, adapts to increasingly complex tumor neck
Form；Flexible couplings 131 between distal end wavy annular thing 120 are also twist.In circumference, rigid connector 130 and soft
Property equally one waveform distance in interval of connector 131.
110 structure of near-end wavy annular thing can be identical with the first embodiment, will not be described here.
4th kind of embodiment：As shown in Figure 15,16, it is that near-end bare bracket section 10 includes a near-end ripple in the present embodiment
Shape ring 110, two or more distal end wavy annular things 120.Wherein near-end wavy annular thing 110 and the first embodiment
In near-end wavy annular 110 structures of thing it is identical.
As shown in figure 16, distal end wavy annular thing 120 is made up of 9 waveforms, is had between two distal end wavy annular things 120
It is uniformly distributed in three circumferences and inclined rigid connector 130, inclined rigid connector 130 connects first distal end waveform
The proximal apices 121a of the distal end summit 121b of ring 120 and adjacent second distal end wavy annular thing 120.In circumference, two
Between individual rigid connector 130, linked together by flexible couplings 131.The proximal apices of the connection of flexible couplings 131
121a is provided with connecting hole 116, and distal end summit 121b is provided with connecting hole 123, for being connected for flexible couplings 131.Near-end
Height with middle 120 waveform of distal end wavy annular thing is 9mm.
The distal end wavy annular thing 120 of distalmost end is identical with the waveform quantity of near-end wavy annular thing 110, and waveform height is omited
More than 120 waveform height of distal end wavy annular thing, waveform height is 10mm, 120 distal tip of distal end wavy annular thing of distalmost end
Point place setting sewing hole 124, and for bare bracket is linked together with overlay film frame section.
Connected mode and adjacent distal end corrugated gasket between near-end wavy annular thing 110 and distal end wavy annular thing 120
Connected mode between shape thing 120 is identical, connects only with 3 inclined rigid connectors 130, and with distal end wavy annular
The rigid connector 130 of thing 120 is in circumference to composition helical form.
In present embodiment, wavy annular thing 100 includes hanging with 100 connectionless least one set of adjacent waveform ring
Proximal apices 125 and/or the hanging distal end summit 126 of least one set, per group of hanging proximal apices 125 include 1 hanging near-end top
Point or 2 adjacent hanging proximal apices, per group of hanging distal end summit 126 includes 1 hanging distal end summit or 2 adjacent hang
Empty distal end summit.These hanging distal end summits 126 and hanging proximal apices 125 save a part of rigidity in bare bracket section 10 and connect
Fitting 130, makes in vacant state between the segment distal summit of above-mentioned adjacent wavy annular thing 100 and proximal apices, can
Integrally bending rigidity is reduced, the hanging distal end summit 126 in this part and hanging proximal apices 125 can be close to blood vessel wall because chainless
It is even slight to be pierced into blood vessel wall, increased the grappling of intraluminal stent.At the same time, because of each group of hanging distal end summit or hanging near
In endvertex, the quantity on hanging summit is less than 2, and both sides have rigid connector and flexible couplings to enter row constraint in the circumferential,
Therefore the above-mentioned waveform with hanging summit will not significantly overturn and go deep into producing new damage in blood vessel wall, to blood vessel.Its
Remaining structure will not be described here with the first embodiment.
Second-the four kind of embodiment is all that distal end wavy annular thing 120 is increased on the basis of the first embodiment
Quantity, during distal end wavy annular thing 120 is located at renal artery and on the downside of renal artery near, the blood vessel shape larger for angle on kidney
State, distal end wavy annular thing 120 is in addition to requiring that avoiding cut-out flows into renal artery, the blood flow of Mesenteric artery, in addition it is also necessary to have
Good compliance is to comply with blood vessel, therefore being obliquely installed for rigid connector 130 both increases tube chamber with flexible couplings 131
The compliance of support, while bare bracket overall length increases, can cause proximal annular thing to be located at more than renal artery more straight
Arteries in so as to anchor pierces 114 structures and can penetrate Ink vessel transfusing completely, with good adherent performance and sweep resistance
Energy.
To adapt to vessel size difference, the different patient in position, according to adult's ventral aorta diameter situation, the present invention
Different model specification can be designed to.Each several part equal diameters in each embodiment of the above, or be in horn mouth form, it is a diameter of
20mm to 36mm, for example, can be preferably 20mm, 22mm, 24mm, 26mm, 28mm, 30mm, 33mm and 36mm, and total length is 30
To 60mm.
Claims (10)
1. a kind of intraluminal stent, including bare bracket section and the overlay film frame section being connected with the bare bracket section, the bare bracket section
Including at least two coaxial wavy annular things and rigid connector, it is characterised in that the bare bracket section also includes nonelastic
And the flexible couplings that arbitrarily can be bent, per two adjacent wavy annular things in described at least two coaxial wavy annular things
Connected by the rigid connector and the flexible couplings, in the circumferential the rigid connector and the flexible couplings
Mixing arrangement, the length of the flexible couplings is slightly larger than the shortest spacing between two wavy annular things.
2. intraluminal stent according to claim 1, it is characterised in that each described wavy annular thing includes multiple continuous head
Tail connects to forming the supporting part of waveform, and all of support zone is arranged on the same face of cylinder, with regard to axis axial symmetry, many
Individual supporting part head and the tail junction forms multiple proximal apices and multiple distal end summits；One in two adjacent wavy annular things
One proximal apices of wavy annular thing pass through rigid connector or soft with the distal end summit of another wavy annular thing
Connector connects.
3. intraluminal stent according to claim 2, it is characterised in that described at least two coaxial wavy annular things include
Near-end wavy annular thing and distal end wavy annular thing, the waveform between adjacent near-end wavy annular thing and distal end wavy annular thing
Phase place is asynchronous；Or the ripple of near-end wavy annular thing is wider than the ripple width of distal end wavy annular thing.
4. intraluminal stent according to claim 1, it is characterised in that the rigid connector is soft with described in the circumferential
Connector is staggered.
5. intraluminal stent according to claim 1, it is characterised in that the rigid connector is relative to the bare bracket section
Axis be obliquely installed, and positioned on the same face of cylinder.
6. intraluminal stent according to claim 2, it is characterised in that the rigid connector and the bare bracket section axis
The angle δ of the vertical circumference of line is 20 °～45 °.
7. intraluminal stent according to claim 1, it is characterised in that the flexible couplings are that sub-thread has high stretching strong
Degree, and the compatible silk thread of human body；Or the blend that the flexible couplings are one or more silk thread Jing multiply blending.
8. intraluminal stent according to claim 7, it is characterised in that the silk thread is made up of macromolecular material, the height
Molecular material includes at least one in PE, PTFE, PET and PP.
9. intraluminal stent according to claim 2, it is characterised in that the wavy annular thing includes and adjacent wavy annular
The hanging proximal apices of the connectionless least one set of thing and/or the hanging distal end summit of least one set, per group of hanging proximal apices include 1
The adjacent hanging proximal apices of individual hanging proximal apices or 2, per group of hanging distal end summit include 1 hanging distal end summit or 2
Individual adjacent hanging distal end summit.
10. intraluminal stent according to claim 1, it is characterised in that the rigid connector is in the axial direction of bare bracket section
On in the shape of a spiral or straight line arrangement；And/or the flexible couplings in the axial direction of bare bracket section in the shape of a spiral or straight line
Arrangement.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410532215.8A CN104287870B (en) | 2014-10-10 | 2014-10-10 | Intraluminal stent |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410532215.8A CN104287870B (en) | 2014-10-10 | 2014-10-10 | Intraluminal stent |
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| CN104287870A CN104287870A (en) | 2015-01-21 |
| CN104287870B true CN104287870B (en) | 2017-03-29 |
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| US8834902B2 (en) | 2012-03-09 | 2014-09-16 | Q3 Medical Devices Limited | Biodegradable supporting device |
| CN105030391B (en) * | 2015-07-07 | 2018-07-20 | 南昌大学 | A kind of intravascular stent with Surface Texture |
| CN105167892A (en) * | 2015-09-02 | 2015-12-23 | 先健科技(深圳)有限公司 | Implanted medical device |
| CN106806043B (en) * | 2015-11-30 | 2019-04-26 | 先健科技(深圳)有限公司 | Intraluminal stent and intraluminal stent system |
| CN105662666B (en) * | 2015-12-30 | 2018-01-30 | 先健科技(深圳)有限公司 | Intraluminal stent |
| JP2019516468A (en) * | 2016-05-25 | 2019-06-20 | キュースリー メディカル デヴァイシズ リミテッドＱ３ Ｍｅｄｉｃａｌ Ｄｅｖｉｃｅｓ Ｌｉｍｉｔｅｄ | Biodegradable support device |
| CN108261252B (en) * | 2016-12-30 | 2024-07-05 | 先健科技(深圳)有限公司 | Lumen stent and delivery system |
| CN108938161B (en) * | 2017-11-17 | 2021-07-06 | 杭州唯强医疗科技有限公司 | Peripheral blood vessel stent |
| CN112561871B (en) * | 2020-12-08 | 2021-09-03 | 中国医学科学院北京协和医院 | Aortic dissection method and device based on flat scanning CT image |
| CN116407337A (en) * | 2021-12-31 | 2023-07-11 | 先健科技(深圳)有限公司 | Tectorial membrane support |
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| CN102499802A (en) * | 2011-09-29 | 2012-06-20 | 微创医疗器械(上海)有限公司 | Filmed stent |
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