CN109172074A - A kind of biodegradable stent of shell-core structure and preparation method thereof - Google Patents
A kind of biodegradable stent of shell-core structure and preparation method thereof Download PDFInfo
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- CN109172074A CN109172074A CN201811185896.XA CN201811185896A CN109172074A CN 109172074 A CN109172074 A CN 109172074A CN 201811185896 A CN201811185896 A CN 201811185896A CN 109172074 A CN109172074 A CN 109172074A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0056—W-shaped, e.g. M-shaped, sigma-shaped
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Physics & Mathematics (AREA)
- Vascular Medicine (AREA)
- Optics & Photonics (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
The invention discloses biodegradable stent of a kind of shell-core structure and preparation method thereof, which is tubular structure, including rack body；The engraved structure that rack body has skeleton and is formed between skeleton；Wherein, skeleton includes: the hypostracum with hollow out tubulose；It is coated on the intermediate stratum nucleare of the hollow out tubulose except hypostracum, intermediate stratum nucleare includes the inner nuclear layer of outer nuclear layer and the reticular structure being coated within outer nuclear layer；And it is coated on the outer shell of the hollow out tubulose except intermediate stratum nucleare；Wherein, inner nuclear layer uses molecular weight for the polyphosphazene polymer lactic acid of 700-800kDa；Outer nuclear layer uses molecular weight for the polyphosphazene polymer lactic acid of 200-300kDa.The biodegradable stent of the shell-core structure, it is easy to spray and sacculus grips processing, do not occur the case where scaffolding thread fracture in process and after processing is completed, under conditions of guaranteeing that biodegradable stent has good degradation property, greatly reduces the difficulty of processing of bracket and the risk of bracket fracture.
Description
Technical field
The invention belongs to the field of medical instrument technology, it is related to a kind of biodegradable stent more particularly to a kind of shell-core structure
Biodegradable stent and preparation method thereof.
Background technique
Stenter to implant operation is the important means of clinically common treatment ischemic cardiovascular disease, but existing market
On generally use is still third generation Metal Drugs FirebirdTM, timbering material includes 316L stainless steel, cochrome and titanium
Alloy etc..Once being implanted into it is necessary to accompany all the life as foreign matter and vascular tissue, patient usually needs to take for a long time this metallic support
Antiplatelet drug antithrombotic.In addition to this, due to metallic support long-time stimulus vascular wall, lead to function of vascular endothelium
Disorder causes local chronic inflammatory and cambium hyperplasia, easily formation in-stent restenosis, even advanced thrombus.
For above-mentioned drawback, biodegradable stent was mentioned before the several years by researcher as this concept of the substitute of metallic support
Out.Biodegradable stent provides mechanical support early period after the implantation, and voluntarily gradually drops in the later period for not needing radial support
Solution, until completely disappearing.To the stimulation of target vessel and its caused local inflammation reaction, endangium after bracket is degradable
Hyperplasia has not just existed, restenosis and thrombus after stenter to implant can be effectively reduced.
This scientific concept of biodegradable stent is very specific, i.e. offer early period support, is gradually dropped after the completion of support function
Grade is until disappear.However meeting the two conditions simultaneously is not easy thing.In order to reach two above-mentioned purposes, in industry
Three big Biodegradable scaffold systems of main research, strengths and weaknesses analysis are as follows:
Degradable magnesium alloy bracket and ferroalloy bracket because its biocompatibility is poor and the uncontrollable hard defects of degradation speed,
Bottleneck is encountered in the application field of biodegradable stent.Degradable polymer bracket is because of its excellent biocompatibility and controllably
Degradation speed be widely studied in the field, but mechanical performance and a balance of degradation speed are still single polymers
The difficult point that material can not overcome.
Why biodegradable stent system using single polymers as material is difficult to meet mechanical performance simultaneously and can drop
Performance is solved, originally simultaneous two paradox of mechanical performance and degradation property are primarily due to, is difficult with single poly-
Object is closed as material and takes into account two performances, so being the limitation of material after all.It is applied to drop with pure polylactic acid PLLA
For solving bracket, it should be controlled in 150kDa with the matched degradation speed of vascular repair, molecular weight between 200kDa to reach,
And in the case where this molecular weight, even if wall thickness control, at 150 microns, radial support is also difficult and conventional metals medication coat
Bracket compares favourably, moreover the wall thickness of normal metallic support is respectively less than 100 microns, and so the competitiveness of biodegradable stent is just
It has a greatly reduced quality.If improving molecular weight toward another extreme consideration in order to meet the requirement of mechanical performance, not only degradation time
Especially very long, high molecular weight can also greatly increase the difficulty of bracket processing, increase the risk of bracket fracture.
Summary of the invention
The purpose of the present invention is cannot be considered in terms of mechanical performance, degradability and can for single polymers in the prior art
The defect of processability, one kind of proposition can meet the biodegradable stent of the shell-core structure of mechanical performance and degradability simultaneously
And preparation method thereof.
Multiple material can only be used compared to traditional, by Physical Processing approach appropriate and unique supporting structure come
Reach while meeting the scheme of above-mentioned requirements.The structure of the biodegradable stent of shell-core structure provided by the invention can be certain
Optimize mechanical support power radially in degree, and effectively reduces the feelings that bracket is broken in processing or use process
Condition.The present invention also provides a kind of preparation methods of the biodegradable stent of shell-core structure, are guaranteeing that it is good that biodegradable stent has
Degradation property under conditions of, greatly reduce bracket difficulty of processing and bracket fracture risk.
To achieve the above object, the invention adopts the following technical scheme:
The first aspect of the invention is to provide a kind of biodegradable stent of shell-core structure, is tubular structure, including bracket
Ontology, the engraved structure that the rack body has skeleton and is formed between the skeleton；Wherein, the skeleton includes:
Hypostracum with hollow out tubulose；
It is coated on the intermediate stratum nucleare of the hollow out tubulose except the hypostracum, the intermediate stratum nucleare includes outer nuclear layer and cladding
The inner nuclear layer of reticular structure within the outer nuclear layer；And
It is coated on the outer shell of the hollow out tubulose except the intermediate stratum nucleare.
Further, the inner nuclear layer uses molecular weight for the polyphosphazene polymer lactic acid of 700-800kDa；The outer nuclear layer is adopted
The polyphosphazene polymer lactic acid for being 200-300kDa with molecular weight.
Further, the molecularly oriented of polyphosphazene polymer lactic acid is unformed shape, crystallinity 20- in the inner nuclear layer
30%.
Further, the inner nuclear layer is with a thickness of 10-20 μm.
It is further preferred that the polyphosphazene polymer lactic acid of the outer nuclear layer fills up in the grid of the inner nuclear layer, and exist respectively
The inner side and outer side of the inner nuclear layer forms 5-15 μm of polymeric layer.
It is further preferred that the intercalated nucleus layer is with a thickness of 20-50 μm, and overall molecule is oriented to unformed shape.
Further, the outer shell and the hypostracum are all made of the polyphosphazene polymer cream that molecular weight is 150-200kDa
Acid, crystallinity 40-50%.
Further, the thickness of the outer shell and the hypostracum is respectively 30-40 μm.
Further, the rack body overall thickness is 80-130 μm.
Further, the outer shell and the hypostracum are transparence.
Further, the inner nuclear layer is translucent, the outer nuclear layer transparence.
Further, the engraved structure is S-shaped, V-arrangement or W-shaped structure, interlaced arrangement.
It is further preferred that several subdivided gaps 160 are offered on the skeleton of the intermediate stratum nucleare 120, between the segmentation
Gap 160 is located at adjacent two engraved structures, 150 junction.
Further, the width of the subdivided gap 160 is 5-30 μm.
The second aspect of the invention is to provide a kind of preparation method of the biodegradable stent of shell-core structure, including as follows
Step:
Step 1, an inner nuclear layer with hollow lumen is provided, inner nuclear layer is cut into reticular structure；
Step 2, outer nuclear layer is formed on the inner nuclear layer of the reticular structure, the inner nuclear layer is arranged in the outer nuclear layer
It is interior, form an intermediate stratum nucleare with inner nuclear layer and outer nuclear layer；
Step 3, a hypostracum and an outer shell with hollow lumen with hollow lumen is provided respectively, respectively by institute
It states hypostracum and outer shell is set in the intermediate stratum nucleare inner side and outer side, and by the outer shell, intermediate stratum nucleare and hypostracum
It is melted into one；
Step 4, the tubing that above-mentioned melting is integrated is cut into the rack body with skeleton and engraved structure.
Further, inner nuclear layer described in step 1 uses molecular weight to be extruded into for the polyphosphazene polymer lactic acid of 700-800kDa
Type, molecularly oriented are unformed shape, crystallinity 20-30%.
Further, inner nuclear layer described in step 1 is cut into reticular structure using laser cutting mode.
Further, inner nuclear layer described in step 2 is arranged in the outer nuclear layer 122 in a manner of wrapping extrusion.
It is further preferred that outer nuclear layer described in step 2 uses molecular weight to squeeze for the polyphosphazene polymer lactic acid of 200-300kDa
It forms out, the intermediate stratum nucleare overall molecule is oriented to unformed shape.
Further, outer shell described in step 3 and hypostracum are all made of the polyphosphazene polymer that molecular weight is 150-200kDa
Lactic acid extrusion molding, and handled through thermal finalization blow-up.
It is further preferred that propelling the price of high score in treated the outer shell and hypostracum through the thermal finalization in step 3
Sub- strand is radial oriented, crystallinity 40-50%.
Further, the tubing with the outer shell, intermediate stratum nucleare and hypostracum is placed in mold in height in step 3
It is melted into one under warm high pressure, melting temperature is 155-180 DEG C, pressure is 600psi or more.
Further, the tubing being integrated is melted described in step 4 is cut into rack body by the way of femtosecond cutting.
The present invention by adopting the above technical scheme, compared with prior art, has the following technical effect that
(1) radial support of the biodegradable stent of the shell-core structure can reach 15psi or more；Inside and outside shell is maximized
The radial oriented and high-crystallinity close to 50% of strand is conducive to mechanical performance；Intermediate stratum nucleare poly-lactic acid in high molecular weight increases
Add radial support intensity；The selection of scaffolding thread subtended angle maximizes radial support；
(2) bracket is easy to spray and sacculus grips processing, does not occur in process and scaffolding thread after processing is completed and breaks
The case where splitting greatly reduces the difficulty of processing of bracket under conditions of guaranteeing that biodegradable stent has good degradation property
With the risk of bracket fracture；
(3) polylactic acid of ectonexine shell 150-200kDa has been confirmed to be the processing request of suitable biodegradable stent,
It is gripped below glass transition temperature and is not likely to produce fracture with being expanded under 37 degree of water environments, the microcosmic processing of scaffolding thread corner
It more can effectively prevent mechanical breaking；
(4) there is not loss of mechanical properties within bracket after the implantation three months；Scaffold polymer 3-6 after the implantation
The moon starts to degrade, and degradation finishes in 3 years.
Detailed description of the invention
Fig. 1 is the three-dimensional structure diagram of the three-layer pipe for the biodegradable stent that the present invention prepares shell-core structure；
Fig. 2 is the lateral sectional structure chart of the three-layer pipe for the biodegradable stent that the present invention prepares shell-core structure；
Fig. 3 is longitudinal sectional structure chart of the three-layer pipe for the biodegradable stent that the present invention prepares shell-core structure；
Fig. 4 is the three-dimensional structure diagram of the biodegradable stent of shell-core structure of the present invention；
Fig. 5 is the main structure figure of the biodegradable stent of shell-core structure of the present invention；
Fig. 6 is the backsight structure chart of the biodegradable stent of shell-core structure of the present invention；
Fig. 7 is the sectional structure chart of the Section A-A of the biodegradable stent of shell-core structure shown in Fig. 6；
Fig. 8 is the sectional structure chart of the section B-B of the biodegradable stent of shell-core structure shown in Fig. 6；
Fig. 9 is the partial enlargement structure chart of C portion on the biodegradable stent of shell-core structure shown in Fig. 4；
Figure 10 is the side block diagram of the biodegradable stent of shell-core structure of the present invention；
Figure 11 is the sectional structure chart in the section D-D of the biodegradable stent of shell-core structure shown in Figure 10；
Figure 12 is the sectional structure chart in the section E-E of the biodegradable stent of shell-core structure shown in Figure 10；
Figure 13 is the partial enlargement structure chart of the part F on the biodegradable stent of shell-core structure shown in Figure 12；
Figure 14 is the micro-structure diagram of corner on the biodegradable stent of shell-core structure of the present invention；
Wherein, each appended drawing reference are as follows:
100- rack body, 110- outer shell, the centre 120- stratum nucleare, 121- inner nuclear layer, 122- outer nuclear layer, 130- inner casing
Layer, 140- skeleton, 150- engraved structure, 160- subdivided gap.
Specific embodiment
The present invention provides a kind of biodegradable stent of shell-core structure, which can optimize diameter to a certain extent
Upward mechanical support power, and effectively reduce in processing or use process that there is a situation where be broken for bracket.The present invention also mentions
The preparation method for having supplied a kind of biodegradable stent of shell-core structure is guaranteeing biodegradable stent with good degradation property
Under the conditions of, greatly reduce the difficulty of processing of bracket and the risk of bracket fracture.Multiple material can only be used compared to traditional,
Reach while meeting the scheme of above-mentioned requirements by Physical Processing approach appropriate and unique supporting structure.
The present invention is described in more detail below by specific embodiment, for a better understanding of the present invention,
But following embodiments are not intended to limit the scope of the invention.
To achieve the above object, the invention adopts the following technical scheme:
As shown in Fig. 4-12, it to be tubular structure, including branch that the present embodiment provides a kind of biodegradable stents of shell-core structure
Frame ontology 100, the engraved structure 150 that the rack body 100 has skeleton 140 and is formed between the skeleton 140；Its
In, the skeleton 140 includes: the hypostracum 130 with hollow out tubulose；The hollow out tubulose being coated on except the hypostracum 130
Intermediate stratum nucleare 120, the intermediate stratum nucleare 120 includes outer nuclear layer 122 and the reticular structure that is coated within the outer nuclear layer 122
Inner nuclear layer 121；And it is coated on the outer shell 110 of the hollow out tubulose except the intermediate stratum nucleare 120.The inner nuclear layer 121
Use molecular weight for the polyphosphazene polymer lactic acid of 700-800kDa；The outer nuclear layer 122 uses molecular weight for the height of 200-300kDa
The poly-lactic acid in high molecular weight of molecule polylactic acid, the intermediate stratum nucleare 120 considerably increases the radial support intensity of bracket.
The biodegradable stent of the shell-core structure is easy to spray and sacculus grips processing, in process and completes the process
The case where being broken afterwards there can be no scaffolding thread.Bracket cannot have loss of mechanical properties within after the implantation three months.Bracket is poly-
It closes object 3-6 after the implantation month and starts to degrade, degradation finishes in 3 years；The mechanical performance of biodegradable stent can be met simultaneously
And degradability.
In one embodiment, the molecularly oriented of polyphosphazene polymer lactic acid is unformed shape, crystallization in the inner nuclear layer 121
Degree is 20-30%；Preferably 22-28%；More preferably 24-26%.And the inner nuclear layer 121 is with a thickness of 10-20 μm；It is preferred that
Ground, the inner nuclear layer 121 is with a thickness of 12-17 μm；It is highly preferred that the inner nuclear layer 121 is reduced to a certain extent with a thickness of 15 μm
Bracket is broken in processing or all use processes.
In one embodiment, as depicted in figs. 11-12, the polyphosphazene polymer lactic acid of the outer nuclear layer 122 fills up the kernel
In the grid of layer 121, and respectively in 5-15 μm of the formation of the inner side and outer side of the inner nuclear layer 121 of polymeric layer, it is preferable that poly-
Nitride layer is closed with a thickness of 6-12 μm, it is highly preferred that polymer layer of thickness is 10 μm.Make so the intermediate stratum nucleare 120 with a thickness of
20-50 μm, preferably 25-45 μm, more preferably 35 μm, and overall molecule is oriented to unformed shape.
In one embodiment, it is 150-200kDa's that the outer shell 110 and the hypostracum 130, which are all made of molecular weight,
Polyphosphazene polymer lactic acid, crystallinity 40-50%, outer shell 110 and the maximized strand of the hypostracum 130 are radial oriented
Be conducive to mechanical performance with the high-crystallinity close to 50%.And the outer shell 110 and the hypostracum 130 use 150-
The polylactic acid of 200kDa has been confirmed to be the processing request of suitable biodegradable stent, is gripped below glass transition temperature and 37
It is expanded under degree water environment and is not likely to produce fracture, the microcosmic processing of scaffolding thread corner more can effectively prevent mechanical breaking.
In one embodiment, the thickness of the outer shell 110 and the hypostracum 130 is respectively 30-40 μm；It is preferred that
The thickness of ground, outer shell 110 and the hypostracum 130 is respectively 32-36 μm；More effectively, outer shell 110 and the hypostracum
130 thickness is respectively 35 μm.As above, 100 overall thickness of rack body is 80-130 μm；Preferably, the rack body
100 overall thickness are 90-110 μm.The diameter of the rack body 100 is 2.5-4.0mm；Preferably, the rack body 100
Diameter is 2.65-3.42mm；It is highly preferred that the diameter of the rack body 100 is 3.0mm.The 80-130 μm of wall thickness the case where
Under, the 2.5-4.0mm diameter biodegradable stent radial support for cutting completion reaches 15psi or more.
In one embodiment, the outer shell 110 and the hypostracum 130 are transparence.The inner nuclear layer 121 is
It is translucent, 122 transparence of outer nuclear layer.
In one embodiment, the engraved structure 150 is S-shaped, V-arrangement or W-shaped structure.As Figure 4-Figure 6, preferably W
Shape structure.Interlaced arrangement, so that skeleton 140 on the basis of guaranteeing has certain mechanical performance, has good drop
Solve performance and machinability.
In one embodiment, as illustrated by figs. 12-13, it is offered on the skeleton of the intermediate stratum nucleare 120 between several segmentations
Gap 160, the subdivided gap 160 are located at adjacent two engraved structures, 150 junction；Preferably, the subdivided gap 160 is described
It is spaced apart on the skeleton of intermediate stratum nucleare 120 along its axis direction.Pass through the intercalated nucleus of the biodegradable stent in the shell-core structure
Subdivided gap 160 made of asking cutting machine to cut as laser, the width of every subdivided gap 160 are opened up on the skeleton of layer 120
Degree is 5-30 μm, preferably 10-25 μm, more preferably 20 μm, for increasing the contact area of biodegradable stent and blood, is increased
The rate of dissolution of the biodegradable stent.
As a preferred embodiment of the present invention, a kind of preparation method of the biodegradable stent of shell-core structure is provided, such as
Shown in Fig. 1-3, specifically comprise the following steps:
Step 1, an inner nuclear layer 121 with hollow lumen is provided, inner nuclear layer 121 is cut into reticular structure；
Step 2, outer nuclear layer 122 is formed on the inner nuclear layer 121 of the reticular structure, the inner nuclear layer 121 is arranged in institute
It states in outer nuclear layer 122, forms an intermediate stratum nucleare 120 with inner nuclear layer 121 and outer nuclear layer 122；
Step 3, a hypostracum 130 and an outer shell 110 with hollow lumen with hollow lumen is provided respectively, point
The hypostracum 130 and outer shell 110 120 inner side and outer side of intermediate stratum nucleare is not set in, and by the outer shell
110, intermediate stratum nucleare 120 and hypostracum 130 are melted into one；
Step 4, the tubing that above-mentioned melting is integrated is cut into the rack body with skeleton 140 and engraved structure 150
100。
In one embodiment, inner nuclear layer 121 described in step 1 uses molecular weight for the polyphosphazene polymer of 700-800kDa cream
Sour extrusion molding, molecularly oriented are unformed shape, crystallinity 20-30%.Inner nuclear layer 121 described in step 1 uses laser
Cutting mode is cut into reticular structure.
In one embodiment, the outer nuclear layer is arranged in inner nuclear layer 121 described in step 2 in a manner of wrapping extrusion
In 122, the polymer of outer nuclear layer 122 can fill up the removed part of inner nuclear layer 121 and the inside and outside formation 5-15 in inner nuclear layer 121
μm polymeric layer.
In one embodiment, outer nuclear layer 122 described in step 2 uses molecular weight for the polyphosphazene polymer of 200-300kDa cream
Sour extrusion molding, intermediate 120 overall molecule of stratum nucleare are oriented to unformed shape, the high-molecular-weight poly of the intermediate stratum nucleare 120
Lactic acid considerably increases the radial support intensity of bracket.
In a preferred embodiment, it is 150- that outer shell 110 described in step 3 and hypostracum 130, which are all made of molecular weight,
The polyphosphazene polymer lactic acid extrusion molding of 200kDa, and handled through thermal finalization blow-up.In step 3 after thermal finalization blow-up processing
The outer shell 110 and hypostracum 130 in macromolecule strand be radial oriented, crystallinity 40-50%.
In a preferred embodiment, will have the outer shell 110, intermediate stratum nucleare 120 and hypostracum 130 in step 3
Tubing be placed in mold under high temperature and pressure and be melted into one, melting temperature is 155-180 DEG C, pressure is 600psi or more.
In a preferred embodiment, the tubing being integrated is melted described in step 4 to cut by the way of femtosecond cutting
At rack body 100, as Figure 4-Figure 6.
On the biodegradable stent of the shell-core structure of the present embodiment, on microstructure, that is, skeleton 140 of rack body 100
The microstructure of scaffolding thread corner is as shown in figure 14, and this supporting structure, can be effective while optimizing bracket radial support
Prevent the fracture of scaffolding thread in the process of processing and using.
Specific embodiments of the present invention are described in detail above, but it is merely an example, the present invention is simultaneously unlimited
It is formed on particular embodiments described above.To those skilled in the art, any couple of present invention carries out equivalent modifications and
Substitution is also all among scope of the invention.Therefore, without departing from the spirit and scope of the invention made by equal transformation and
Modification, all should be contained within the scope of the invention.
Claims (24)
1. a kind of biodegradable stent of shell-core structure is tubular structure, including rack body (100), which is characterized in that described
The engraved structure (150) that rack body (100) has skeleton (140) and is formed between the skeleton (140)；Wherein, described
Skeleton (140) includes:
Hypostracum (130) with hollow out tubulose；
It is coated on the intermediate stratum nucleare (120) of the hollow out tubulose except the hypostracum (130), the intermediate stratum nucleare (120) includes
The inner nuclear layer (121) of outer nuclear layer (122) and the reticular structure being coated within the outer nuclear layer (122)；And
It is coated on the outer shell (110) of the hollow out tubulose except the intermediate stratum nucleare (120).
2. the biodegradable stent of shell-core structure according to claim 1, which is characterized in that the inner nuclear layer (121) uses
Molecular weight is the polyphosphazene polymer lactic acid of 700-800kDa；The outer nuclear layer (122) uses molecular weight for the high score of 200-300kDa
Sub- polylactic acid.
3. the biodegradable stent of shell-core structure according to claim 2, which is characterized in that high in the inner nuclear layer (121)
The molecularly oriented of molecule polylactic acid is unformed shape, crystallinity 20-30%.
4. the biodegradable stent of shell-core structure according to claim 2, which is characterized in that inner nuclear layer (121) thickness
It is 10-20 μm.
5. the biodegradable stent of shell-core structure according to claim 4, which is characterized in that the height of the outer nuclear layer (122)
Molecule polylactic acid is filled up in the grid of the inner nuclear layer (121), and is formed respectively in the inner side and outer side of the inner nuclear layer (121)
5-15 μm of polymeric layer.
6. the according to claim 1, biodegradable stent of shell-core structure described in 4 or 5, which is characterized in that the intermediate stratum nucleare
(120) with a thickness of 20-50 μm, and overall molecule is oriented to unformed shape.
7. the biodegradable stent of shell-core structure according to claim 1, which is characterized in that the outer shell (110) and institute
It states hypostracum (130) and is all made of the polyphosphazene polymer lactic acid that molecular weight is 150-200kDa, crystallinity 40-50%.
8. the biodegradable stent of shell-core structure according to claim 1, which is characterized in that the outer shell (110) and institute
The thickness for stating hypostracum (130) is respectively 30-40 μm.
9. the biodegradable stent of shell-core structure according to claim 8, which is characterized in that the rack body (100) is total
With a thickness of 80-130 μm.
10. the biodegradable stent of shell-core structure according to claim 8, which is characterized in that the rack body (100)
Diameter be 2.5-4.0mm.
11. the biodegradable stent of shell-core structure according to claim 1, which is characterized in that the outer shell (110) and
The hypostracum (130) is transparence.
12. the biodegradable stent of shell-core structure according to claim 1, which is characterized in that the inner nuclear layer (121) is
It is translucent, outer nuclear layer (122) transparence.
13. the biodegradable stent of shell-core structure according to claim 1, which is characterized in that the engraved structure (150)
S-shaped, V-arrangement or W-shaped structure, interlaced arrangement.
14. the biodegradable stent of shell-core structure according to claim 13, which is characterized in that the intermediate stratum nucleare (120)
Skeleton on offer several subdivided gaps (160), the subdivided gap (160) be located at adjacent two engraved structure (150) connection
Place.
15. the biodegradable stent of shell-core structure according to claim 14, which is characterized in that the subdivided gap (160)
Width be 5-30 μm.
16. a kind of preparation method of the biodegradable stent of shell-core structure, which comprises the steps of:
Step 1, an inner nuclear layer (121) with hollow lumen is provided, inner nuclear layer (121) is cut into reticular structure；
Step 2, it is formed outer nuclear layer (122) on the inner nuclear layer (121) of the reticular structure, inner nuclear layer (121) setting exists
In the outer nuclear layer (122), an intermediate stratum nucleare (120) with inner nuclear layer (121) and outer nuclear layer (122) is formed；
Step 3, a hypostracum (130) and an outer shell (110) with hollow lumen with hollow lumen is provided respectively, point
The hypostracum (130) and outer shell (110) intermediate stratum nucleare (120) inner side and outer side is not set in, and will be described outer
Shell (110), intermediate stratum nucleare (120) and hypostracum (130) are melted into one；
Step 4, the tubing that above-mentioned melting is integrated is cut into the rack body with skeleton (140) and engraved structure (150)
(100)。
17. the biodegradable stent of shell-core structure according to claim 16, which is characterized in that inner nuclear layer described in step 1
(121) use molecular weight for the polyphosphazene polymer lactic acid extrusion molding of 700-800kDa, molecularly oriented is unformed shape, crystallinity
For 20-30%.
18. the biodegradable stent of shell-core structure according to claim 16, which is characterized in that inner nuclear layer described in step 1
(121) reticular structure is cut into using laser cutting mode.
19. the biodegradable stent of shell-core structure according to claim 16, which is characterized in that inner nuclear layer described in step 2
(121) it is arranged in a manner of wrapping extrusion in the outer nuclear layer (122).
20. the biodegradable stent of shell-core structure according to claim 19, which is characterized in that outer nuclear layer described in step 2
(122)) use molecular weight for the polyphosphazene polymer lactic acid extrusion molding of 200-300kDa, intermediate stratum nucleare (120) overall molecule
It is oriented to unformed shape.
21. the biodegradable stent of shell-core structure according to claim 16, which is characterized in that outer shell described in step 3
(110) it is all made of molecular weight with hypostracum (130) and is the polyphosphazene polymer lactic acid extrusion molding of 150-200kDa, and blown through thermal finalization
Rise processing.
22. the biodegradable stent of shell-core structure according to claim 21, which is characterized in that fixed through the heat in step 3
Type propel the price of macromolecule strand in treated the outer shell (110) and hypostracum (130) be it is radial oriented, crystallinity is
40-50%.
23. the biodegradable stent of shell-core structure according to claim 16, which is characterized in that step will have institute in (3)
The tubing for stating outer shell (110), intermediate stratum nucleare (120) and hypostracum (130), which is placed in mold, is melt into one under high temperature and pressure
Body, melting temperature is 155-180 DEG C, pressure is 600psi or more.
24. the biodegradable stent of shell-core structure according to claim 16, which is characterized in that melted described in step (4)
The tubing being integrated is cut into rack body (100) by the way of femtosecond cutting.
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| CN102065794A (en) * | 2008-06-20 | 2011-05-18 | 阿玛安斯医药私人公司 | Stent fabrication via tubular casting processes |
| US20120089221A1 (en) * | 2008-02-25 | 2012-04-12 | Abbott Cardiovascular Systems Inc. | Bioabsorbable stent with layers having different degradation rates |
| CN103142335A (en) * | 2012-02-10 | 2013-06-12 | 东华大学 | Thermoplastic degradable fabric woven bracket and preparation method thereof |
| CN104353129A (en) * | 2014-10-23 | 2015-02-18 | 上海百心安生物技术有限公司 | Intravascular stent and preparation method thereof |
| CN107693854A (en) * | 2016-08-04 | 2018-02-16 | 上海微创医疗器械（集团）有限公司 | Tubing for preparing support and preparation method thereof, support and preparation method thereof |
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2018
- 2018-10-11 CN CN201811185896.XA patent/CN109172074B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120089221A1 (en) * | 2008-02-25 | 2012-04-12 | Abbott Cardiovascular Systems Inc. | Bioabsorbable stent with layers having different degradation rates |
| CN102065794A (en) * | 2008-06-20 | 2011-05-18 | 阿玛安斯医药私人公司 | Stent fabrication via tubular casting processes |
| CN103142335A (en) * | 2012-02-10 | 2013-06-12 | 东华大学 | Thermoplastic degradable fabric woven bracket and preparation method thereof |
| CN104353129A (en) * | 2014-10-23 | 2015-02-18 | 上海百心安生物技术有限公司 | Intravascular stent and preparation method thereof |
| CN107693854A (en) * | 2016-08-04 | 2018-02-16 | 上海微创医疗器械（集团）有限公司 | Tubing for preparing support and preparation method thereof, support and preparation method thereof |
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| CN109172074B (en) | 2020-08-25 |
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