CN206777427U - A kind of complete biological absorbable blood vessel polymer support of implanted - Google Patents
A kind of complete biological absorbable blood vessel polymer support of implanted Download PDFInfo
- Publication number
- CN206777427U CN206777427U CN201620927186.XU CN201620927186U CN206777427U CN 206777427 U CN206777427 U CN 206777427U CN 201620927186 U CN201620927186 U CN 201620927186U CN 206777427 U CN206777427 U CN 206777427U
- Authority
- CN
- China
- Prior art keywords
- class
- support
- shape
- degree
- blood vessel
- 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.)
- Active
Links
Landscapes
- Prostheses (AREA)
Abstract
It the utility model is related to a kind of complete biological absorbable blood vessel polymer support of implanted, including the ring waveform support bar of more than five, and interval is connected to the connecting rod between the support bar, the support bar of the support is alternately formed by connecting by class " Ω " shape ripple and class " m " shape ripple, wherein, class " Ω " shape ripple and class " m " shape ripple respectively by two groups just " s " and fall " s " connect and compose, connection between two neighboring support bar is to be connected by connecting rod in class " Ω " shape wave crest and class " m " shape wave base, the polymer support reticulation patterns pattern is to be formed by thin-wall pipes through laser engraving.The program reconciled polymer support radial support power and wall thickness, compliance between contradiction, realize that three takes into account, possess and good pass through performance, also it can give lesion enough mechanical supports in the special time of wound healing, and progressively it is absorbed by organisms after wound healing, endothelialization is good, is effectively reduced stent restenosis rate and the risk of late period thrombus in stents.
Description
Technical field
The invention belongs to medical instruments field, more particularly to a kind of complete biological absorbable blood vessel Polymer-supported of implanted
Frame.
Background technology
Since first case metallic support Palmaz-Schatz in 1985 is implanted into human body, solved support Successful treatment with interventional
The very high problem of simple balloon expandable epoch restenosis rate of having determined, turn into the Main Means of clinical treatment, with increasing
After metallic support implantation human body, it has been found that due to inflammatory reaction, neointimal hyperplasia, the reconstruct of blood vessel negativity and support endothelialization
The reasons such as delay, in-stent restenosis rate are still up to 20% or so.
In order to solve this problem, first generation polymer coating bracket for eluting medicament arises at the historic moment.Bracket for eluting medicament
There are 30~40% by the postoperative ISR of PCI by the simple PTCA epoch, by the 15~25% of the BMS epoch, be reduced to
Present less than 10%, it might even be possible to say, the appearance of bracket for eluting medicament is one of milestone of coronary intervention, is had
Epoch-making meaning.
However, the analysis and studies have shown that non-degradable delivered in the Barcelona of in September, 2006 ESC/WCC meetings gather
Due to drug-carrying polymer coating, in rack surface, for a long time there is permanent sexual stimulus, office to vascular wall in remaining to compound bracket for eluting medicament
Portion's inflammatory reaction etc., so that the increase of late period thrombus in stents risk, the hyperplasia etc. of inner membrance.
The delay of endothelialization is closely related after the generation of studies have shown that late period thrombus in stents and stenting.Endothelialization refers to
After stenter to implant blood vessel, cradling piece, which imbeds, forms groove in vascular wall, is not embedded into site residues some endothelial cells, these endotheliums
Cell should gradually be completed in multicenter growth, mutually fusion, the whole branch inwall of Landfill covering, this process within several weeks.It is interior
Skin degree is that the important indicator of support advanced thrombus probability of happening is predicted in histology.
Long-term remaining causes the chronic injury of blood vessel to permanent drug support in the blood vessels, and the later stage can cause media
The endometrial hyperplasia of atrophy, Aneurysmformation and reactivity, ultimately result in the generation of reangiostenosis.Only support is needed to exist in clinic
Play mechanical support to blood vessel in the special time of wound healing, therefore, best blood vessel polymer support should be given
The enough supports of lesion and progressively it is absorbed by organisms after healing.
There is the polymer blood vessel stent of many biodegradables at present, to temporary transient support blood vessels wall, keep
Unobstructed blood vessel, and can are progressively absorbed by organisms in the later stage.
But currently conventional macromolecule polymer material in the prevalence of：Mechanical strength not enough causes support radial direction resistance to compression
Poor performance, pressure, which is held, to be easily broken off, and material has mechanical relaxation behavior, causes support performance unstable, radial support power is with the time
Drop, the problems such as shelf life is short.In order to improve deficiency of the PLA in mechanical performance, much go together both at home and abroad all to PLA blood
Pipe polymer support is studied, and Venkatraman etc. makes the support force intensity of PLLA supports reach 0.21 by modified technique
~0.25MPa, and the support strength of common stainless steel stent is 0.20~0.22MPa, in mechanical strength, PLLA is reachable
It is horizontal to metallic support.Applicant's early-stage Study result applies for a patent CN102499999B, to for preparing polymer support
PLA tubing is modified, and is further used for making support strength meet to require during support.
In addition, listing or having a variety of pattern structures in the support ground, wherein m (or w) shapes and n (or Ω) shape are to grind
Think in studying carefully preferably can embodiment, main purpose enables support radial compression and radial dilatation, and can still keep foot
Enough support performances, so as to reduce acute resilience and reduce the incidence of stent restenosis.For example, US5514154A is proposed first
A kind of structure figure support of m (or w) shapes and n (or Ω) shape.
But the program is more clearly disadvantageous in the presence such as radial support power and compliance, in follow-up study, to understand
The problem of certainly it is present, researcher are transformed and optimized, such as：Applicant's early-stage Study scheme CN201431532Y is provided
A kind of coronary artery bracket, the support include the support bar of the ring waveform of more than five, and interval is connected between the support bar
Connecting rod, wherein, the support bar at the support both ends is " Ω " shape ripple, between both ends support bar support bar adjacent thereto
Connecting rod is connected between two adjacent " Ω " shape wave crests；The support bar of the support center section is by " m " and " Ω " shape ripple
Alternating is formed by connecting, and the connecting rod between distal end second row support bar and the 3rd row's support bar is connected to two adjacent " m " shapes
Between wave base, the connecting rod between remainder support bar is connected between adjacent " m " shape wave base and " Ω " shape wave crest.The party
Case is more suitable for the application of metallic support, and when for polymer support scheme, its support force and compliance are by more obvious
Restriction.
In addition, as CN1923154A provides a kind of expanding blood vessel of puncture shaping surgery treatment angiemphraxis
Support.This kind of structure stand applies also for peripheral vascular in addition to for angiocarpy, and knot is reticulated through laser engraving by thin micro tube
Structure, its structure are formed by connecting by multigroup waveform bracing ring by connecting rod, and every group of waveform bracing ring is by a variety of unit ripples of 2-5 groups
Combination form, connected using 2 to 10 connecting rods between adjacent waveform bracing ring.Said structure design ensure that stenter to implant
Rear tissue prolapse is small, avoids cradling piece when pressure is held and expanded interference, add compliance.But the program is being set
When putting smaller pressure and hold diametrically, and being particularly used for polymer support, there is also larger for the support of its section and stability
Deficiency.
In addition, the tube wall thickness of existing biodegradable stent is all compared metallic support by the reason for material and manufacturing process
Thickness, for 2 times or more of metallic support, in this way, adding endothelial cell climbs up cradling piece and fully wrapped around difficulty so that branch
Frame surface is difficult to endothelialization again, has influence on the risk of thrombus in stents.
At present, the various biological absorbable supports completely of in the market can not still realize the perfect unity of each technical indicator,
Particularly in terms of the radial support power of support, wall thickness and compliance.
The content of the invention
In view of the problem of prior art is present, the invention reside in provide a kind of implanted complete biological absorbable blood vessel polymerization
Thing support, the contradiction reconciled between the radial support power and wall thickness, compliance of complete biological absorbable support, realizes that three is simultaneous
Care for, meet clinical needs.
The technical scheme of the present invention that solves the problems, such as is as follows：
A kind of complete biological absorbable blood vessel polymer support of implanted, it is characterised in that including more than five ring-types
Waveform support bar, and interval are connected to the connecting rod of the support bar support, the support bar of the support by class " Ω " shape ripple and
Class " m " shape ripple is alternately formed by connecting, wherein, class " Ω " shape ripple and class " m " shape respectively by two groups just " s " and " s " is connected and composed,
Connection between two neighboring support bar is to be connected by connecting rod in class " Ω " shape wave crest and class " m " shape wave base, connecting rod
Be shaped as straight-bar.
Wherein, using class " Ω " shape ripple and class " m " shape respectively by two groups just " s " and fall " s " connect and compose, if using straight
Bar is formed by connecting with straight-bar transition similar structures, and its stress concentration of either crest still connects straight-bar is very bright
It is aobvious, easily make stent fatigue, produce fracture, and by core design of the present invention using two groups just " s " and fall " s " connect, can be with
Greatly reduce the stress concentration of crest and connecting rod position, not only increase the support performance of support, moreover it is possible to keep support performance
Stability.
For foregoing just " s " and, the angle of " s " linkage section is 5~45 degree to one of further preferred scheme, preferably 10~
30 degree, strengthen support performance as far as possible, improve stability.The special design on the one hand held based on pressure after by external diameter
Size considers, is found by many experiments, and can also be made by external diameter, another aspect after pressure is held not only is had influence on beyond this scope
Into the extruding of support bar and connecting rod, so that damage medicine film, influences the release of medicine.
One of further preferred scheme is that the scope of angle [alpha] 1 of foregoing class " Ω " shape wave crest is 130~180 degree；Class " Ω "
The scope of angle [alpha] 2 of shape wave base is 130~180 degree.
The above-mentioned angular range of use of class " Ω " shape wave crest and wave base, with just " s " or fall " s " be connected the angle of arc-shaped transition section
It is sufficiently large to spend scope so that class " Ω " shape ripple can't be very big in the amplitude opened or shunk, there is provided need what is opened during support
Amplitude need not be very big, and the amplitude of contraction is also little, not only provides good support performance, moreover it is possible to the stability of retention property.
One of further preferred scheme is that the scope of angle beta 1 of left (or right) wave crest of foregoing class " m " shape is 90~130 degree；
The scope of angle beta 2 of left (or right) wave base of class " m " shape is 130~180 degree.
Left (or right) wave crest of class " m " shape use above-mentioned angular range, and with just " s " or " s " is connected the angle of arc-shaped transition section
It is sufficiently large to spend scope so that class " m " shape ripple can't be very big in the amplitude opened or shunk, there is provided the width opened is needed during support
Degree need not be very big, and the amplitude of contraction is also little, not only provides good support performance, moreover it is possible to the stability of retention property.Class
The above-mentioned angular range of use of left (or right) wave base of " m " shape, is advantageous to control with being connected the angular range of straight-bar so as to the portion
The stress and width divided are any limitation as.
One of further preferred scheme is " s " tie point tangent line with the angle γ's 1 of class " Ω " shape wave crest circular arc tangential line
Scope is 5~30 degree；" s " tie point tangent line and the angle γ 2 of class " Ω " shape wave base circular arc tangential line scope are 5~30 degree；“s”
Tie point tangent line and the angle δ 1 of class " m " shape wave crest circular arc tangential line scope are 5~30 degree；" s " tie point tangent line and class " m " shape
The angle δ 2 of wave base circular arc tangential line scope is 5~30 degree.
The angle of " s " tie point tangent line and class " Ω " or class " m " shape wave crest (bottom) circular arc tangential line uses above range, connects
Point is rounder and more smooth, stress transmission and it is scattered evenly, be not easy to form serious stress concentration and influence support performance and its stability.
One of further preferred scheme is that the angle η 1 of class " m " shape wave base and connecting rod scope is 0~30 degree；Class
" Ω " shape wave crest and the angle η 2 of connecting rod scope are 0~30 degree.
The angular range of class " m " shape wave base (or class " Ω " shape wave crest) and connecting rod uses above range, on the one hand favourable
In the width of control connecting rod, and then control and press the external diameter after holding；On the other hand appropriate increase class " m " shape wave base (class " Ω " shape
Wave crest) angle, the angular range of itself and class " m " shape wave crest is based on, in the case, its stress concentration degree is smaller,
The serious stress concentration of class " m " shape ripple can be effectively reduced.
Furthermore on the basis of the preferred scheme of aforementioned structure design, further preferred class " Ω " shape ripple wave crest and wave base
The proportion 0.5~2, preferably 0.8~1.5 of the length of line and connecting rod；Line and the company of class " m " shape ripple wave crest and wave base
The proportion 0.5~2 of the length of extension bar, preferably 0.8~1.5.
Class " Ω " shape or class " m " shape wave crest and the line of wave base are too short relative to connecting rod, not only easily cause connecting rod
It is obvious with the junction stress concentration of class " Ω " shape ripple wave crest and class " m " shape ripple wave base, it can also increase the stress concentration of connecting rod,
Fatigue strength is exceedingly added while adding compliance；Class " Ω " shape ripple wave crest and the line of wave base are relative to connecting rod mistake
It is long, easily cause to support waveform to be embedded in the support waveform of adjacent ring when pressure is held, cause support bar to extrude, so that damage medicine
Film, influence the release of medicine.
As can be seen here, designed by aforementioned structure, plus class " Ω " shape, class " m " shape length with being connected the preferred of pole length
Proportion, synergy is served in performance.Coordinated by foregoing aspects, so as to solve radial support power and wall
Contradiction between thick, compliance, realizes that three takes into account.Relatively thin support wall thickness, designed in good support pattern structure
Under, still keep radial support performance good enough, and the excellent in stability of performance；Meanwhile have benefited from relatively thin branch
Frame wall thickness and good support pattern structure, the pressure of support hold that external diameter is smaller, and compliance is good, can smoothly reach lesion, reduce
The wound of implantation process and the damage of support.
On the basis of foregoing scheme, the width of further preferred support bar and connecting rod is identical or different；And/or
The width of the width of the support bar at support both ends and the support bar of support center section is identical or different；And/or support both ends
Connecting rod width and support center section connecting rod width it is identical or different.
By the identical or different design of width, technically, identical scheme is easier to realize and processing, still
In order to meet the needs of support or intensity, through the preferably different scheme of a step, in particular it is preferred that the ring close to support both ends
Or two ring waveform support bar thickness be more than close to center section support bar width.The width of support bar and connecting rod
Preferred scope is 0.10~0.30mm.
The design for focusing on pattern structure of the present invention, the side that its structure can adjust by prior art or suitably
Prepared by case, the reticulation patterns pattern of usual support is to be formed by thin-wall pipes through laser engraving.
By foregoing conceptual design, the present invention has found that the polymer support being prepared is controlling by numerous studies
Internal diameter is 1.50~5.00mm, in the case that wall thickness is 0.05~0.2mm so that radial strength is 240kpa~280kpa, is filled
Divide the support strength for meeting support.
Further preferred scope is that internal diameter is 2.50~4.00mm, and wall thickness is 0.08~0.18mm, and radial strength is
250kpa~270kpa, meet farthest to control wall thickness sufficiently thin in the case of radial strength.
Further, the polymer support is 0.5-2.0N/mm, preferably 1.0~2.0N/ in per unit axial length load
Mm, meet the performance of various vascular lesion implantation.
Per unit axial length, which loads, refers to the load (pressure or pressure) of each per unit axial length, i.e., support it is overall by
Load/total stent length, represented with N/mm.
Found by animal experiment study method, polymer support provided by the invention both can wound healing it is specific when
It is interior to give lesion enough mechanical supports, and be progressively absorbed by organisms after wound healing, endothelialization is good, effectively
Reduce stent restenosis rate and the risk of late period thrombus in stents.
In the present invention, the material composition of the polymer support is preferably the one or two of following polymers, or
Its mixture, including：PLA, PLLA, DL- PLAs, polyglycolic acid, polycaprolactone etc..
In order to meet the Clinical practice needs of support, rack surface (including inner side or outside) exists coated with blood vessel is suppressed
Coating that is narrow or suppressing the medicine that implantation is repelled, coated carrier can be the various carriers with good biocompatibility.
Coated carrier material preferably includes PLLA (PLLA), polylactic-co-glycolic acid (PLGA), racemic
PLA (PDLLA), polyethylene glycol, PEG-PCL, polysorbate, PVP, xylan alcohol, polyglycerol ester, sea
Mosanom, chitosan, chitin, glucan, poly- hard acid esters, poly- citrate etc.；Above-mentioned coating is loaded with the medicine of therapeutic dose
Thing, anti-oxidation medicine, anticoagulants are preferably included, anticancer class medicine, suppresses vascular smooth muscle cell curing class medicine, is anti-
One or more in scorching class medicine or immune suppressant drug.
Above-mentioned anti-oxidation medicine includes superoxide dismutase, catalase, Co-Q10, glutathione peroxidase
Enzyme；Anticoagulants include aspirin, heparin, clopidogrel etc.；Anticancer class medicine includes colchicin, taxol；Suppression
Vascular smooth muscle cell curing class medicine processed includes angiogenic peptide, cortin, calcium ion antagonist；Anti-inflammatory drug includes more raw
Mycin, Depsidomycin, KanglemycinC, Spergualin, Mytiocin, Gllooxin；Immune suppressant drug bag
Include rapamycin, Ciclosporin A, cyclosporin C, brefeldin A.Said medicine and coated carrier mass ratio be 1: 10~
2: 1, preferably 1: 3~1: 1.
The present invention includes relative to the beneficial effect of prior art：
(1) the invention provides a kind of complete biological absorbable blood vessel polymer support of implanted, the support possesses excellent
Pattern structure design, under relatively thin support wall thickness, still keep good enough radial support performance, and stability
It is all good.
(2) the invention provides a kind of complete biological absorbable blood vessel polymer support of implanted, the support to possess relatively
Relatively thin support wall thickness and good support pattern structure, the pressure of support hold that external diameter is smaller, and compliance is good, have stronger pass through
It ability and operability, can smoothly reach lesion, reduce the wound of implantation process and the damage of support.
(3) the invention reside in a kind of complete biological absorbable blood vessel polymer support of implanted is provided, complete life has been reconciled
Contradiction between the radial support power and wall thickness, compliance of thing bioabsorbable stent, realizes that three takes into account, meets clinical needs.
(4) the invention reside in a kind of complete biological absorbable blood vessel polymer support of implanted is provided, with rack surface (bag
Include inner side either outside) have coated with the coating for suppressing the medicine that blood vessel repels in narrow or suppression implantation, coated carrier
Good biocompatibility, meet the Clinical practice needs of support.
(5) support preparation method of the present invention is simple, is easy to reappear, and is adapted to industrialization production.
Brief description of the drawings
Fig. 1 is a kind of flat deployable structure schematic diagram of the complete biological absorbable blood vessel polymer support of implanted, wherein,
Support bar 1, connecting rod 2, class " Ω " shape ripple 3, class " m " shape ripple 4.
Fig. 2 is waveform by just " s " and the schematic diagram of " s " connection of falling, wherein, with determining for class " Ω " shape ripple or class " m " shape ripple
Circle of position arc datum line makees tangent line L1 (or L1 ＇), and the tangent line L2 (or L2 ＇) of circular arc and the camber line of " s " phase contact, L3 (or L3 ＇) are
The intermediate bar tangent line of " s ", just " s " and the angle of " s " linkage section of falling refer to L1 (or L1 ＇) and L2 (or L2 ＇) angle, L3
(or L3 ＇) and L2 (or L2 ＇) angle with and L1 (or L1 ＇) and L2 (or L2 ＇) angle it is basically identical, i.e., tangent camber line enters
Mouth and the angle of outlet are basically identical, the symmetry of transition arc are ensure that, so as to ensure the uniformity of its stress.Wherein, L1,
L2 and L3, L1 ＇, L2 ＇ and L3 ＇ are respectively respectively one group, and angle is corresponding.
Fig. 3-1 to 3-7 is class " m " shape ripple and class " Ω " shape involves schematic diagram with connecting rod, wherein, class " Ω " shape wave crest
Angle [alpha] 1, the angle [alpha] 2 of class " Ω " shape wave base；The angle beta 1 of left (or right) wave crest of class " m " shape；Left (or right) wave base of class " m " shape
Angle beta 2；Angle γ 1, " s " tie point tangent line and class " Ω " shape of " s " tie point tangent line and class " Ω " shape wave crest circular arc tangential line
The angle γ 2 of wave base circular arc tangential line；Angle δ 1, " s " tie point of " s " tie point tangent line and class " m " shape wave crest circular arc tangential line are cut
The angle δ 2 of line and class " m " shape wave base circular arc tangential line；The angle η 1 of class " m " shape wave base and connecting rod, class " Ω " shape wave crest and company
The angle η 2 of extension bar.
Fig. 4-1 is the schematic diagram of class " Ω " shape ripple；Fig. 4-2 is the partial enlarged drawing of Fig. 4-1 class " Ω " shape ripple, wherein,
L4 is class " Ω " shape ripple wave crest and the line of wave base.
The schematic diagram of Fig. 5-1 class " m " shape ripple；Fig. 5-2 is the partial enlarged drawing of Fig. 5-1 class " m " shape ripple, wherein, L5
For class " m " shape ripple wave crest and the line of wave base.
Fig. 6-1 is that the flat deployable structure of another complete biological absorbable blood vessel polymer support of implanted of the present invention shows
It is intended to, stent ends bar is wider than that center-pole is wide, and Fig. 6-2,6-4 are the enlarged diagrams of Fig. 6-1 connecting rods, and L6 is connecting rod
Length, Fig. 6-3 are the partial enlarged drawings of Fig. 6-1 class " Ω " shape ripple, and Fig. 6-5 is the partial enlargement of Fig. 6-1 class " m " shape ripple
Figure, the length ratio of the line and connecting rod of class " Ω " shape ripple wave crest and wave base is L4：The company of L6, class " m " shape ripple wave crest and wave base
The length of line and connecting rod ratio is L5：L6.
Fig. 7 is the flat deployable structure signal of the complete biological absorbable blood vessel polymer support of another implanted of the invention
Figure.
Embodiment
With reference to preferred embodiments and drawings, the present invention is described in further detail, but the embodiment invented is not
It is limited to this.
A kind of complete biological absorbable blood vessel polymer support of 1 implanted of embodiment
Referring to shown in accompanying drawing 1,2 and 3-1 to 3-7, a kind of complete biological absorbable blood vessel polymer support of implanted, material
Ring waveform support bar 1 more than PLA, including five, and interval are connected to the connecting rod 2 of the support of support bar 1, institute
The support bar 1 for stating support is alternately formed by connecting by class " Ω " shape ripple 3 and class " m " shape ripple 4, the connection between two neighboring support bar
It is to be connected by connecting rod 2 in class " Ω " shape wave crest and class " m " shape wave base.
Class " m " the shape ripple 4, as shown in figure 3-1, and class " Ω " shape ripple 3, as shown in figure 3-2, respectively by two groups just " s "
Connected and composed with " s ", it is as shown in Figure 2 respectively.
The shape of connecting rod between the two neighboring support bar is straight-bar.
The complete biological absorbable blood vessel polymer support of this implanted, is formed by thin-wall pipes through laser engraving.
A kind of complete biological absorbable blood vessel polymer support of 2 implanted of embodiment
Referring to shown in accompanying drawing 1,2 and 3-1 to 3-7, a kind of complete biological absorbable blood vessel polymer support of implanted, including
The ring waveform support bar 1 of five or more, and interval are connected to the connecting rod 2 of the support of support bar 1, with embodiment 1 not
With part in this specific embodiment, the width of the support bar and connecting rod is variant, the support two end portions
The width of support bar is most thick, and the width of the connecting rod of support two end portions takes second place, then the width to remaining support bar, remaining connection
The width of bar is most thin.Wherein, just " s " and fall " s " linkage section angle be 5-10 degree.
A kind of complete biological absorbable blood vessel polymer support of 3 implanted of embodiment
Referring to shown in accompanying drawing 1,2 and 3-1 to 3-7, a kind of complete biological absorbable blood vessel polymer support of implanted, including
The ring waveform support bar 1 of five or more, and interval are connected to the connecting rod 2 of the support of support bar 1, with embodiment 1 not
With part in this specific embodiment, the width of the support bar and connecting rod is variant, the support two end portions
The width of support bar is most thick, and the width of the connecting rod of support two end portions takes second place, then the width to remaining support bar, remaining connection
The width of bar is most thin.Wherein, just " s " and fall " s " linkage section angle be 40-45 degree.
A kind of complete biological absorbable blood vessel polymer support of 4 implanted of embodiment
Referring to shown in accompanying drawing 1,2 and 3-1 to 3-7, a kind of complete biological absorbable blood vessel polymer support of implanted, including
The ring waveform support bar 1 of five or more, and interval are connected to the connecting rod 2 of the support of support bar 1, with embodiment 1 not
With part in this specific embodiment, wherein, just " s " and the angle of " s " linkage section of falling is 10 degree；α 1 in class " Ω " shape
It it is 130 degree with the angles of α 2；The angles of β 1 are 130 degree in class " m " shape, and the angles of β 2 are 180 degree；Angle γ 1 and the angles of γ 2 are 5
Degree, angle δ 1 and the angles of δ 2 are 5 degree；The scopes of angle η 1 of class " m " shape wave base and connecting rod be 30 degree, class " Ω " shape wave crest and
The scopes of angle η 2 of connecting rod are 30 degree.
A kind of complete biological absorbable blood vessel polymer support of 5 implanted of embodiment
Referring to shown in accompanying drawing 1,2 and 3-1 to 3-7, a kind of complete biological absorbable blood vessel polymer support of implanted, including
The ring waveform support bar 1 of five or more, and interval are connected to the connecting rod 2 of the support of support bar 1, with embodiment 1 not
With part in this specific embodiment, wherein, just " s " and the angle of " s " linkage section of falling is 30 degree；α 1 in class " Ω " shape
It is 180 degree with the angles of α 2, the angles of β 1 are 90 degree in class " m " shape, and the angles of β 2 are 130 degree；Angle γ 1 and the angles of γ 2 are 30
Degree, angle δ 1 and the angles of δ 2 are 30 degree；The scopes of angle η 1 of class " m " shape wave base and connecting rod be 0 degree, class " Ω " shape wave crest and
The scopes of angle η 2 of connecting rod are 0 degree.
A kind of complete biological absorbable blood vessel polymer support of 6 implanted of embodiment
Referring to shown in accompanying drawing 1,2 and 3-1 to 3-7, a kind of complete biological absorbable blood vessel polymer support of implanted, including
The ring waveform support bar 1 of five or more, and interval are connected to the connecting rod 2 of the support of support bar 1, with embodiment 1 not
With part in this specific embodiment, wherein, just " s " and the angle of " s " linkage section of falling is 20 degree；α 1 in class " Ω " shape
It it is 160 degree with the angles of α 2, the angles of β 1 are 100 degree in class " m " shape, and the angles of β 2 are 150 degree；Angle γ 1 and the angles of γ 2 are 15
Degree, angle δ 1 and the angles of δ 2 are 15 degree；The scopes of angle η 1 of class " m " shape wave base and connecting rod are 10 degree, class " Ω " shape wave crest
The scopes of angle η 2 with connecting rod are 10 degree.
A kind of complete biological absorbable blood vessel polymer support of 7 implanted of embodiment
Referring to shown in accompanying drawing 1,2,3-1 to 3-7,4-1 to 4-2,5-1 to 5-2 and 6-1 to 6-5, a kind of implanted is completely raw
Thing can absorb blood vessel polymer support, includes the ring waveform support bar 1 of five or more, and interval is connected to the support bar
The connecting rod 2 of 1 support, difference from Example 4 is in this specific embodiment, class " Ω " the shape ripple wave crest and ripple
The ratio of the line at bottom and the length of connecting rod is 1, the ratio of the length of the line and connecting rod of class " m " shape ripple wave crest and wave base
For 1.
A kind of complete biological absorbable blood vessel polymer support of 8 implanted of embodiment
Referring to shown in accompanying drawing 1,2,3-1 to 3-7,4-1 to 4-2,5-1 to 5-2 and 6-1 to 6-5, a kind of implanted is completely raw
Thing can absorb blood vessel polymer support, includes the ring waveform support bar 1 of five or more, and interval is connected to the support bar
The connecting rod 2 of 1 support, difference from Example 5 is in this specific embodiment, class " Ω " the shape ripple wave crest and ripple
The ratio of the line at bottom and the length of connecting rod is 1.5, the ratio of the length of the line and connecting rod of class " m " shape ripple wave crest and wave base
Example is 1.5.
A kind of complete biological absorbable blood vessel polymer support of 9 implanted of embodiment
Referring to shown in accompanying drawing 1,2,3-1 to 3-7,4-1 to 4-2,5-1 to 5-2,6-1 to 6-5 and 7, a kind of implanted is complete
Biological absorbable blood vessel polymer support, include the ring waveform support bar 1 of five or more, and interval is connected to the support
The connecting rod 2 of the support of bar 1, difference from Example 6 in this specific embodiment, class " Ω " the shape ripple wave crest and
The ratio of the line of wave base and the length of connecting rod is 1.2, the length of the line and connecting rod of class " m " shape ripple wave crest and wave base
Ratio is 1.2.And stent ends bar is wider than that center-pole is wide, and stent ends bar is wide：The wide about 1.1-1.2 of center-pole.
Wherein, the polymer support of previous embodiment 1-9 is 1.50~5.00mm controlling internal diameter, wall thickness is 0.05~
In the case of 0.2mm, after testing, its radial strength is 240kpa~280kpa, fully meets the support strength of support.Further
Preferred scope is that internal diameter is 2.50~4.00mm, and wall thickness is 0.08~0.18mm, and radial strength is 250kpa~270kpa, maximum
The control wall thickness of degree is sufficiently thin.
In order to meet the requirement that uses of implantation, the complete biological absorbable blood vessel polymer support surface of this implanted (including
Inner side either outside) coated with blood vessel is suppressed narrow or suppress the coating of the medicine that implantation is repelled, coated carrier has good
Good biocompatibility, can effectively treat hemadostewnosis lesion.
The performance detection experimental program of embodiment 10
Support strength is tested：
The compression ratio that equilibrium is imposed to the polymer support of embodiment 1-9 extrudes, when occur power significantly reduce or diameter
When reducing at least 50%, record load and related diameter, respective diameters per unit axial length load the requirement for meeting table 1.
The support radial support intensity of table 1
As a result show that the radial support volume unit axial length load of the support of test all meets 0.5~2.0N/mm, from
And embodying polymer support has good support force performance；Wherein, embodiment 4-9 has more excellent support force performance, unit
Axial length loads 1.0~2.0N/mm；Especially it is more excellent with embodiment 6 and 9, respectively 1.5N/mm and 1.8N/mm.
Stability experiment
A kind of complete biological absorbable blood vessel polymer support of implanted of the present invention, 40 DEG C ± 2 DEG C are respectively stored in,
75%RH ± 5%RH and 25 DEG C ± 2 DEG C, carry out accelerating in the environment of 60%RH ± 5%RH and real-time stability is tested.Current
Research shows that preferable biodegradable stent only need to play mechanical support in the special time of wound healing to blood vessel, to
Progressively absorbed by body after giving the mechanical support that lesion is enough and wound healing.For coronary artery bracket, this special time period is generally acknowledged
Typically in or so half a year.Evaluate a kind of complete biological absorbable blood vessel polymer support of implanted of the present invention within the time period
Support performance stability, Acceleration study and real-time stabilization result are respectively as shown in table 2 and table 3.
The accelerated stability test result of table 2
The real-time stability result of the test of table 3
| Time (moon) | Per unit axial length loads (N/mm) |
| 1 | 0.5~2.0 |
| 2 | 0.5~2.0 |
| 3 | 0.5~2.0 |
| 4 | 0.5~2.0 |
| 5 | 0.5~2.0 |
| 6 | 0.5~2.0 |
| 7 | 0.5~2.0 |
| 8 | 0.5~2.0 |
| 9 | 0.5~2.0 |
As a result show that the radial support volume unit axial length of the support of test was supported in 9 months to be still maintained at
0.5~2.0 N/mm, there is good support performance stability so as to embody polymer support；Embodiment 4-9 different times are surveyed
The support force deviation obtained is smaller, has more excellent stability of strutting system, and per unit axial length load is still maintained at 1.0~2.0N/
Mm, and just started after 6th month hydraulic performance decline occur, it is especially more excellent with embodiment 6 and 9, it is respectively maintained at 1.5~1.8N/mm
With 1.8~2.0N/mm, and just started after 7th month hydraulic performance decline occur.
The animal protocols of embodiment 10
Experimental method：Choose 30~40Kg of weight, health white pig, the healthy miniature pig of 6~August, respectively at left coronal dynamic
Arteries and veins descending anterior branch, Circumflex branch and (or) arteria coronaria dextra are respectively implanted into the polymer support described in 1 piece of embodiment 3, are implanted into 2~3 pieces altogether
Polymer support.Endothelialization degree, thrombus etc. are primarily upon in special time period.
SEM figures observe polymer support substantially completely endothelialization out of 30 days brace sections；From 0 day and the OCT of 90 days
Comparison diagram observes that polymer support surface keeps complete without any thrombus, cradling piece is adhered to, and endothelium covering is good, no fracture
Occur, still high-visible, so as to embody, polymer support has good support performance and stability is all good.It is meanwhile real
There is basically identical effect after applying a 4-9 stenter to implant, it is especially more excellent with embodiment 6 and 9.
Conclusion：Found by animal experiment study method, polymer support provided by the invention both can be in wound healing
To give lesion enough mechanical supports in special time, and be progressively absorbed by organisms after wound healing, endothelialization is good,
It is effectively reduced stent restenosis rate and the risk of late period thrombus in stents.
Above content is to combine the further details of explanation that specific preferred embodiment is done to the present invention, but not
Represent that the specific implementation of the present invention is limited to these explanations.For those skilled in the art,
On the premise of not departing from present inventive concept, some simple deductions can also be made or replaced, be regarded as belonging to the present invention's
Protection domain.
Claims (13)
1. a kind of complete biological absorbable blood vessel polymer support of implanted, it is characterised in that including the ring-type ripple of more than five
Shape support bar, and interval are connected to the connecting rod between the support bar, and the support bar of the support is by class " Ω " shape ripple and class
" m " shape ripple is alternately formed by connecting, wherein, class " Ω " shape ripple and class " m " shape ripple respectively by two groups just " s " and " s " is connected and composed,
Connection between two neighboring support bar is to be connected by connecting rod in class " Ω " shape wave crest and class " m " shape wave base, connecting rod
For straight-bar.
2. a kind of complete biological absorbable blood vessel polymer support of implanted as claimed in claim 1, it is characterised in that just
" s " and the angle of " s " linkage section are 5~45 degree.
A kind of 3. complete biological absorbable blood vessel polymer support of implanted as claimed in claim 1, it is characterised in that class
The scope of angle [alpha] 1 of " Ω " shape wave crest is 130~180 degree, and the scope of angle [alpha] 2 of class " Ω " shape wave base is 130~180 degree；Class " m "
The scope of angle beta 1 of shape left or right wave crest is 90~130 degree；The scope of angle beta 2 of class " m " shape left or right wave base is 130~180
Degree.
A kind of 4. complete biological absorbable blood vessel polymer support of implanted as claimed in claim 2, it is characterised in that class
The scope of angle [alpha] 1 of " Ω " shape wave crest is 130~180 degree, and the scope of angle [alpha] 2 of class " Ω " shape wave base is 130~180 degree；Class " m "
The scope of angle beta 1 of shape left or right wave crest is 90~130 degree；The scope of angle beta 2 of class " m " shape left or right wave base is 130~180
Degree.
5. the complete biological absorbable blood vessel polymer support of a kind of implanted as described in claim 1,2,3 or 4, its feature exist
In " s " tie point tangent line and the angle γ 1 of class " Ω " shape wave crest circular arc tangential line scope are 5~30 degree, " s " tie point tangent line
Scope with the angle γ 2 of class " Ω " shape wave base circular arc tangential line is 5~30 degree；" s " tie point tangent line and class " m " shape wave crest circular arc
The angle δ 1 of tangent line scope is 5~30 degree, the scope of " s " tie point tangent line and the angle δ 2 of class " m " shape wave base circular arc tangential line
For 5~30 degree.
6. the complete biological absorbable blood vessel polymer support of a kind of implanted as described in claim 1,2,3 or 4, its feature exist
In the angle η 1 of " m " shape wave base and connecting rod scope is 0~30 degree；The model of class " Ω " shape wave crest and the angle η 2 of connecting rod
Enclose for 0~30 degree.
7. a kind of complete biological absorbable blood vessel polymer support of implanted as claimed in claim 5, it is characterised in that " m "
The angle η 1 of shape wave base and connecting rod scope is 0~30 degree；Class " Ω " shape wave crest and the angle η 2 of connecting rod scope be 0~
30 degree.
8. the complete biological absorbable blood vessel polymer support of a kind of implanted as described in claim 1,2,3 or 4, its feature exist
In the proportion 0.5~2 of the length of the line and connecting rod of class " Ω " shape ripple wave crest and wave base；Class " m " shape ripple wave crest and ripple
The line at bottom and the proportion of the length of connecting rod 0.5~2.
9. the complete biological absorbable blood vessel polymer support of a kind of implanted as described in claim 1,2,3 or 4, its feature exist
In the width of support bar and connecting rod is identical or different；The width of the support bar at support both ends and the support of support center section
The width of bar is identical or different；The width of the connecting rod at support both ends is identical with the width of the connecting rod of support center section or not
Together.
10. the complete biological absorbable blood vessel polymer support of a kind of implanted as described in claim 1,2,3 or 4, its feature
Be, the polymer support internal diameter is 1.50~5.00mm, and wall thickness is 0.05~0.2mm, radial strength be 240kpa~
280kpa。
A kind of 11. complete biological absorbable blood vessel polymer support of implanted as claimed in claim 10, it is characterised in that institute
It is 0.5-2.0N/mm that polymer support, which is stated, in per unit axial length load.
12. the complete biological absorbable blood vessel polymer support of a kind of implanted as described in claim 1,2,3 or 4, its feature
It is, the material of the polymer support is：PLA, polyglycolic acid or polycaprolactone.
A kind of 13. complete biological absorbable blood vessel polymer support of implanted as claimed in claim 12, it is characterised in that institute
State polymer support surface and be coated with the coating for being loaded with medicine.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201620927186.XU CN206777427U (en) | 2016-08-23 | 2016-08-23 | A kind of complete biological absorbable blood vessel polymer support of implanted |
| PCT/CN2017/098108 WO2018036434A1 (en) | 2016-08-23 | 2017-08-18 | Implant-type, completely bioabsorbable, vascular polymer stent |
| CN201780040433.1A CN109640882B (en) | 2016-08-23 | 2017-08-18 | Implantable completely-bioabsorbable intravascular polymer stent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201620927186.XU CN206777427U (en) | 2016-08-23 | 2016-08-23 | A kind of complete biological absorbable blood vessel polymer support of implanted |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN206777427U true CN206777427U (en) | 2017-12-22 |
Family
ID=60703352
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201620927186.XU Active CN206777427U (en) | 2016-08-23 | 2016-08-23 | A kind of complete biological absorbable blood vessel polymer support of implanted |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN206777427U (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106236342A (en) * | 2016-08-23 | 2016-12-21 | 深圳市信立泰生物医疗工程有限公司 | A kind of implanted complete biological absorbable blood vessel polymer support |
| CN109640882A (en) * | 2016-08-23 | 2019-04-16 | 深圳市信立泰生物医疗工程有限公司 | A kind of complete biological absorbable blood vessel polymer support of implanted |
| CN113952597A (en) * | 2021-11-17 | 2022-01-21 | 科塞尔医疗科技（苏州）有限公司 | Balloon catheter assembly |
-
2016
- 2016-08-23 CN CN201620927186.XU patent/CN206777427U/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106236342A (en) * | 2016-08-23 | 2016-12-21 | 深圳市信立泰生物医疗工程有限公司 | A kind of implanted complete biological absorbable blood vessel polymer support |
| CN109640882A (en) * | 2016-08-23 | 2019-04-16 | 深圳市信立泰生物医疗工程有限公司 | A kind of complete biological absorbable blood vessel polymer support of implanted |
| CN109640882B (en) * | 2016-08-23 | 2021-03-26 | 深圳市信立泰生物医疗工程有限公司 | Implantable completely-bioabsorbable intravascular polymer stent |
| CN106236342B (en) * | 2016-08-23 | 2024-04-30 | 深圳信立泰医疗器械股份有限公司 | Implantable complete biological absorbable vascular polymer stent |
| CN113952597A (en) * | 2021-11-17 | 2022-01-21 | 科塞尔医疗科技（苏州）有限公司 | Balloon catheter assembly |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US9211205B2 (en) | Bioabsorbable medical device with coating | |
| Ma et al. | Paclitaxel/sirolimus combination coated drug-eluting stent: in vitro and in vivo drug release studies | |
| CN101563117B (en) | Bioabsorbable medical device with coating | |
| WO2016173553A1 (en) | Support and drug delivery device | |
| CN109640882A (en) | A kind of complete biological absorbable blood vessel polymer support of implanted | |
| CN206777427U (en) | A kind of complete biological absorbable blood vessel polymer support of implanted | |
| JPWO2007040250A1 (en) | Indwelling stent | |
| CN105833358B (en) | Intracranial drug eluting stent system and preparation method thereof | |
| CN105726174B (en) | A kind of intravascular stent, preparation method and application | |
| CN203436435U (en) | Cerebrovascular drug-eluting stent | |
| CN106236342A (en) | A kind of implanted complete biological absorbable blood vessel polymer support | |
| CN106691647B (en) | A kind of biodegradable metals intravascular stent and its application | |
| CN104870028A (en) | Fully absorbable intraluminal devices and methods of manufacturing the same | |
| KR20150145422A (en) | Hybrid Vascular Stent | |
| CN201055442Y (en) | Novel blood vessel support | |
| JP2021506467A (en) | Charged implantable medical device and how to prepare it | |
| CN105726178B (en) | A kind of intravascular stent, its preparation method and application | |
| JP2004222953A (en) | Indwelling stent | |
| CN111214748A (en) | Drug eluting balloon and balloon catheter | |
| CN203988521U (en) | A kind of asymmetric conical intravascular stent | |
| CN101239216A (en) | Novel sacculus dilating catheter | |
| CN106618821B (en) | A kind of intravascular stent for preventing reangiostenosis and preparation method thereof | |
| CN208552143U (en) | A kind of endovascular stent and product | |
| CN112263360A (en) | In vivo drug eluting stent and preparation method thereof | |
| Shi et al. | Safety and efficacy of a novel 3D-printed bioresorbable sirolimus-eluting scaffold in a porcine model |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CP01 | Change in the name or title of a patent holder | ||
| CP01 | Change in the name or title of a patent holder |
Address after: 518118 No.1, Guihua 5th Road, big industrial zone, Pingshan New District, Shenzhen City, Guangdong Province Patentee after: Shenzhen Xinlitai Medical Equipment Co.,Ltd. Address before: 518118 No.1, Guihua 5th Road, big industrial zone, Pingshan New District, Shenzhen City, Guangdong Province Patentee before: SHENZHEN SALUBRIS BIOMEDICAL ENGINEERING Co.,Ltd. |