CN104274867B - Degradable polymer bracket and its forming and machining method and application - Google Patents
Degradable polymer bracket and its forming and machining method and application Download PDFInfo
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- CN104274867B CN104274867B CN201410086319.0A CN201410086319A CN104274867B CN 104274867 B CN104274867 B CN 104274867B CN 201410086319 A CN201410086319 A CN 201410086319A CN 104274867 B CN104274867 B CN 104274867B
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Abstract
Invention describes a kind of degradable in vivo bracket and its forming with application.The bracket is made of biodegradable material, and the internal stent structure is zigzag and/or the double chamfering structures of braiding shape structure, arc-shaped structure, circular arc, braiding and bridge structure.The method is needed using a kind of rapid shaping system, and the molding system includes extrusion equipment, the operating system of four Shaft fixed position modules and a set of control working condition.After control system editing procedure, the degradable polymer bracket of various structures is made according to the structure wire for editing setting in the fiber filament that extrusion equipment can be allowed to be squeezed out.The change of its program is convenient, is easier to prepare ideal intravascular stent, and have preferable radial support power.
Description
Technical field
The present invention relates to a kind of bracket and its forming and applications, specifically, being related to a kind of gathering for degradable in vivo
Polymer scaffold and its forming and machining method and application.
Background technique
When leading to hemadostewnosis, occlusion in human body because of lesion, it usually needs using interventional therapy method in lesion
Blood vessel in the intravascular stent that is placed in.It is used to support blood vessel, restores blood circulation.Some intravascular stents also have pre- anti-restenosis
Effect.Intravascular stent generallys use metal or processing of high molecular material is made, and first intravascular stent pressure is held on foley's tube,
Intravascular stent is transported to diseased region by interventional method, is then expanded by pressurizing device to sacculus pressure sheet, by bracket
Vascular lesion position is placed on after strutting.Intravascular stent for a long time or can be stayed temporarily in human vas.Intravascular stent can be applied
Among the surgical operation of cardiovascular and cerebrovascular, the other fields such as peripheral blood vessel and non-vascular can also be applied to, therefore have very
Important role.
Usually used metallic blood vessel bracket, circumferential intensity substantially 3N/cm, since metallic support in vivo can be permanent
Property exist, to blood vessel generate long-term foreign matter stimulation to can line artery benign remodeling, once and in intravascular stent again
It is narrow, it is difficult to handle, and have life threat to patient.It is difficult to take out once ging wrong after permanent stents implantation.Therefore
Degradable biological bracket seems even more ideal, it can play the role of vessel support within a certain period of time, makees completing its support
It is absorbed by the body or is discharged after.Wherein high molecular degradable bracket has preferable flexibility, convenient for being delivered to the mesh of lesion
Cursor position, this feature adds other advantages etc. of high molecular material, so that high molecular material is answered more extensively in recent years
With.
Currently, the degradable biomaterials such as polylactic acid (PLA), l-lactic acid (PLLA) are used to prepare peripheral blood vessel branch
Frame, to improve deficiency existing for metallic support, such as metallic support easily leads to reangiostenosis, second operation.But China is specially
Sharp document CN102429749A discloses the bracket of common biodegradable material preparation, and radial support power is weaker, simultaneously
It discloses, in order to improve the radial force of the bracket, Chinese patent CN101925370A provides a kind of intravascular stent for preparing
Method, including 3 steps: being first configured to fiber for biodegradable material, then mutually bonds fiber or interlacing forms nonwoven
Cloth, then non-woven fabrics is made into cylindric bracket；Chinese patent literature CN102429749A on this basis, provides a kind of system
The processing method of standby Biodegradable scaffold: it is provided with the original pipe of bio-degradable material preparation；To the original pipe
Base applies pressure, prepares shaping pipe；Shaping pipe is prepared into the Biodegradable scaffold.But the method is divided into
Multiple steps, preparation process very complicated.
Summary of the invention
The present invention uses novel manufacturing process, a kind of method for completely newly producing internal bracket is provided, using this method
Preparing bracket can reach easy to operate, one-step shaping, substantially reduce production cost, and the bracket of preparation is made to have comparatively ideal life
Object compatibility, degradability.Meanwhile the present invention provides a kind of biodegradable stent and its applications, have preferably than similar bracket
Radial force and flexibility etc., can satisfy play certain supporting role while, additionally it is possible to convenient for pressure hold, be then sent to
Lesion locations.
To achieve the goals above, present invention employs following schemes:
Biodegradable stent in a kind of organism, the material for preparing the bracket can be selected from polylactic acid (PLA), l-lactic acid
(PLLA), polyethylene glycol hydroxyacetic acid (PGA), polycaprolactone polycaprolactone (PCL), polyethylene glycol (PEG), polyanhydride,
Poly- (beta-hydroxy-butanoic acid ester), polydioxanone, poly- (DTH of iminocarbonic acid), polypropylene, fumaric acid one of or
Several mixtures or copolymer, or other degradable high molecular materials are mixed with, the bracket is have an axis three
Dimension shape, pref. cylindrical, the internal structure of the bracket is double in zigzag and/or braiding shape structure, arc-shaped structure, circular arc
Chamfering structure, braiding and bridge structure.
Preferably, the rack surface is coated with cytostatic drug, and the drug is taxol and/or thunder
Pa mycin.
In any of the above-described scheme preferably, the bracket is used for peripheral vascular stents and body cavity inner support.
In any of the above-described scheme preferably, the zigzag and/or braiding shape structure are six peaks, seven peaks or eight peak knots
Structure.
In any of the above-described scheme preferably, the zigzag and/or braiding shape structure are open loop and/or closed loop configuration.
In any of the above-described scheme preferably, the zigzag structure is zigzag in the same direction and/or reversed zigzag structure.
In any of the above-described scheme preferably, the arc-shaped structure, arc angle are 90 ° or 115 ° or 120 ° or spell
Connect circular arc.
In any of the above-described scheme preferably, it is described braiding and bridge structure be two bridges, six peak structure, three bridges, six peak structure,
Three bridges, seven peak structure, eight peak structure of two bridges, eight peak structure, three bridges, eight peak structure or four bridges.
In any of the above-described scheme preferably, the bracket outer diameter is 5-8mm.
In any of the above-described scheme, the more preferably described bracket outer diameter is 6mm.
In any of the above-described scheme, the more preferably described bracket outer diameter is 7mm.
In any of the above-described scheme, the more preferably described bracket outer diameter is 8mm.It is excellent in any of the above-described scheme
Choosing, the stent length are 20-120mm.
In any of the above-described scheme, the more preferably described stent length is 20mm.
In any of the above-described scheme, the more preferably described stent length is 30mm.
In any of the above-described scheme, the more preferably described stent length is 45mm.
In any of the above-described scheme, the more preferably described stent length is 50mm.
In any of the above-described scheme, the more preferably described stent length is 70mm.
In any of the above-described scheme, the more preferably described stent length is 85mm.
In any of the above-described scheme, the more preferably described stent length is 100mm.
In any of the above-described scheme, the more preferably described stent length is 120mm.
In any of the above-described scheme preferably, the circumferential intensity of the bracket is 0.7-3.0N/cm.
The bracket is prepared using a kind of rapid shaping system.The molding system includes an extrusion equipment and one
The operating system of set control working condition.More specifically, the molding system, which includes at least, a set of feed system and extrusion
System, four Shaft fixed position modules, temperature control system.In optimal embodiment, each independent material-transporting system is one
A macromolecule melting extrusion system, can be with the thermo-fuse of extruding macromolecular material.Four Shaft fixed position modules refer to be controlled by computer
Space X, Y, the 4th axis of Z axis and rotation, which is driven by stepper motor or servo motor, it can accurately basis
It needs to rotate by certain speed, stop, forward or back rotation.Swingle can equip heater or in temperature controlled environment
Lower operation, to control the pliability and stickiness of conveying material, to play the optimal performance of material.For example, hot-fusible high-molecular
Silk can have very good adhesion with other materials in conveying and keep certain shapes, and thermo-fuse can be adhered to and be met with it
Early period squeeze out silk on.For each given high molecular material, need to establish a set of ideal combination parameter to guarantee phase
Adjacent macromolecule extrudate bracket has enough adhesion strengths.This set combination parameter includes rate of extrusion, the mobile speed of material extrusion system
Rate and melt chamber temperature etc..
Entire preparation flow is as follows, first by computerized control system editing procedure, according to the ideal structure of the bracket
Reasonable processing wiring path is designed, and after then material being sent into the feed bin of extrusion equipment, extruder can be by equipment
Determine program and squeeze out fiber filament, extrusion silk is accurately placed on to the specific position of rotary shaft according to layout and track route,
To prepare the bracket of setting structure.
The system is equally applicable to the polymeric stent of preparation mixed type material, is designed according to the structure of bracket, successively
Different high molecular materials is squeezed on rotating rod.
The method of the forming biodegradable stent includes the following steps:
1) structure of computer program design bracket is used；
2) according to the supporting structure of design, automatic or manual generates bracket processing program；
3) extruder operating parameter is set, and waiting facilities reach setup parameter value；The parameter includes processing temperature, adds
The distance between hot pin temperature, rate of extrusion, processing speed, jet size, spray head and heating rod；
4) pellet is added in the feed bin of equipment, extruder can be according to the wiring path set in the control system successively
Fiber is squeezed out to prepare the biodegradable stent；
5) bracket of extrusion is used for subsequent pressure and the processes such as holds.
In any of the above-described scheme preferably, the pellet is that Biodegradable polymer material or biodegradable are high
The mixture of molecular material and other nonmetallic materials or auxiliary agent.
In any of the above-described scheme preferably, the nonmetallic materials are one of hydroxyapatite, tricalcium phosphate
Or more than one mixtures.
In any of the above-described scheme preferably, the auxiliary agent is coating and/or developer.
In any of the above-described scheme preferably, the coating is polyethylene glycol, polycaprolactone, polyvinylpyrrolidone
One of or more than one mixtures.
In any of the above-described scheme preferably, the developer is one of elements such as gold, tungsten or more than one are mixed
Close object.
Another aspect of the present invention additionally provides the structure design to the biodegradable stent of preparation.It can design and can be easy real
Existing processing route preferably comprises zigzag processing route, braiding shape processing route, Z-shaped braiding shape processing route and arc-shaped volume
Knit processing route.Including according to each processing route, and using the main structure of the biodegradable stent of four Shaft fixed position modules extrusion
Peak and bridge, peak indicate the raised position in the structure of the biodegradable stent processed, similar to the wave in sinusoidal or cosine curve
Peak；Peak and valley in the supporting structure are opposite, and paddy is concave position, similar to the trough in sinusoidal or cosine curve.Work as branch
Frame obtains the Method of Spreading Design figure of the structure when surface is axially splitted and is unfolded from low side to top, longitudinal arrangement
The number at peak is peak number in each column.Generally, the angle at peak is smaller, then easier to be held by pressure.Bridge is between peak-to-valley or peak-
Connection between peak.
Zigzag processing route is divided into zigzag processing route in the same direction and reversed zigzag processing route.Zigzag in the same direction processes road
The practical tendency of line is that ring by ring carries out, and the second ring trend is carried out after the first ring, is all annular in shape in rotation, structure
Lap has adjustment effect to the final performance of product.The main part of bracket is by zigzag straight line and is connected to two zigzags
Short-term composition between straight line, is referred to as Z-line and bridging.The angle of two Z-lines is referred to as peak.In this structure design in the same direction
In, the zigzag straight line of each column is same direction, i.e. peak to peak, and paddy is to paddy.Each column bridge joint straight line number it is identical and successively between
Every.The structure that reversed zigzag processing route obtains also is closed loop zigzag structure, the zigzag of each column and the straight line of previous column
Zigzag forms the hexagonal structure of closed loop or semiclosed loop at reversed arrangement, just like honeycomb.This closed loop configuration makes bracket exist
More stable to a certain extent, mechanical property is improved.Honeycomb structure and half honeycomb structure are alternately present but also bracket
The pressure that will not influence later period bracket due to excessively improving for mechanical property holds effect.
Bracket can be supported open loop structure or closed loop configuration, the starting end and end of bracket preparation by weaving shape processing route
In the same side.The great advantage of this kind design is that non-overlapping path occurs.Braiding structure can efficiently avoid duplicate paths pair
Bracket pressure holds the influence of uneven thickness one, but in some cases, and bracket pressure, which holds elongation, to become larger.It is long after pressure is held in order to guarantee
Degree is no more than the Marking ring at sacculus both ends, then in the design, the original length of bracket needs to shorten, and supporting structure can be designed as
Closed loop braiding structure.
Z-shaped, which weaves shape processing route, to be processed by the way of weaving wire, and whole wire mode is also Z-shaped braiding,
But ditto a supporting structure is slightly different specific gage travelling path.On supporting structure prepared by this wire mode or protect
Zigzag structure is hold, and bracket Z-shaped straight line portion is not overlapped, only has overlapping in the place of bridging, therefore at bridging more
It is tough, the bracket of two bridges can be reduced into as needed.
Arc-shaped braiding processing route is the line for being arranged to processing route to have certain radian, it is generally the case that identical
The bracket of peak number, angle is bigger, and the radial strength of bracket is higher, and angle is bigger, and the radian of bracket is more unobvious, thus bracket
Mechanical property also change correspondingly.Chamfering can also be added in the straight line of same bridging connecting place, be that the bracket prepared becomes circular arc
Double chamfering structures generally still keep arc structure in bracket left end and right end for the uniformity of the end of guarantee bracket,
It is added without chamfering.
Cantilever tip and bottom end are longitudinally cut off and obtain plane outspread drawing.
Under normal conditions, for the bracket of the same money specification of identical dimensional parameters, peak number is more, then can make each peak
Angle it is smaller, this also means that preferable flexibility, then the bracket pressure for being finally more advantageous to the later period is held, just can make up for it because
Influence for lap to bracket, caused by bracket pressure to hold diameter inhomogenous.Therefore, can according to product finally needed for property
Can, suitable peak number is selected, the peak number often selected has six peaks, seven peaks or eight peaks.
The number of bridging can also be changed according to different designs.Under normal circumstances, the bracket bridging at six peaks and seven peaks
Number be up to three, the bracket bridging number at eight peaks is up to four.But according to the final design of bracket, the number of bridging
Mesh can also be reduced accordingly.The number of bridging is fewer, and the flexibility of bracket is better.For the mechanical property of bracket, especially radially
Support force is one of the important parameter for evaluating its performance.Therefore it can need after the step of completion prepares machining support to institute
The bracket for stating Different Results tests radial force respectively.Preferably, it is measured using radial force tester.
To radial support force in pharmaceuticals industry standard YY/T0663-08 is defined as: self expandable implantation material is accordingly being implanted into
Generated power under diameter.Bracket radial force is maximum value when straight linear changes.Test result is in addition to big with radial force
It is small to indicate, it is also evaluated sometimes with circumferential intensity.The circumferential force of circumferential intensity, that is, unit length, it is generally the case that numerical value is got over
Greatly, show that bracket radial support power is better, intensity is bigger.And have preferably using the bracket that this kind of the method preparation processes
Radial support power, therefore it can resist prolonged blood flow in human body and wash away, will not cause easily the adherent bad of bracket or
The problems such as collapsing of person's scaffolding thread, i.e., there is no use unsafe risk.The conversion formula of circumferential intensity and radial support power
As follows,
Wherein L is stent length, unit mm.
The many because being known as of radial force are influenced, process conditions, supporting structure, pressure comprising processing hold mode.To press the side of holding
For formula, presses mode of holding to hold including a step pressure and held with multistep pressure.Pressure holds rate, pressure holds temperature, pressure holds rear diameter and pressure hold it is rear whole
Qi Du etc. is the factor of radial force when influencing bracket test.Mass range is to hold size and test result according to pressure to determine
's.Reasonable mass range guarantees that bracket will not be such that radial force declines due to kicking the beam, and will not be difficult to press due to overweight and hold.
The invention has the following advantages over the prior art: bracket of the invention uses biodegradable biomaterial
Preparation, as polylactic acid (PLA), l-lactic acid (PLLA), polyethylene glycol hydroxyacetic acid (PGA), polycaprolactone (PCL),
Polyethylene glycol (PEG), polyanhydride, poly- (beta-hydroxy-butanoic acid ester), polydioxanone, poly- (DTH of iminocarbonic acid), poly- third
The copolymer or mixture of alkene, fumaric acid etc. or above-mentioned material, naturally it is also possible to be the degradable mixing for being mixed with other components
High molecular material, these materials have good biocompatibility, and bracket can be degraded with the time in vivo, is absorbed by the human body
Or excrete, thus the problem of avoiding the problem that reangiostenosis, also avoiding second operation.Meanwhile the present invention by pair
Supporting structure is designed, and successfully improves the radial force of bracket made of high molecular material, makes its mechanical property and metal branch
Frame is suitable, even better.Moreover, preparing macromolecule intravascular stent using preparation method of the present invention, it can be used for peripheral blood vessel etc.
The small diameter tubes blood vessel such as Large Diameter Pipeline and coronary vasodilator, and preparation method of the invention is simple, easy to operate, disposal molding.
Detailed description of the invention
Fig. 1 is the schematic diagram of the machining path and lap that indicate that Z-shaped supporting frame is unfolded along hatching.
Fig. 2 is the schematic diagram for indicating six peak Z-shaped supporting frame planar developments.
Fig. 3 is the schematic diagram for indicating eight peak Z-shaped supporting frame planar developments.
Fig. 4 is the schematic diagram for indicating the expansion of six peak closed loop zigzag structural plans
Fig. 5 is the plane outspread drawing for indicating six peaks braiding shape structure stand.
Fig. 6 is the plane outspread drawing for indicating six peak closed loops braiding shape structure.
Fig. 7 is the plane outspread drawing for indicating eight peak closed loops braiding shape structure stand.
Fig. 8 is the plane outspread drawing for indicating two bridges, six peak Z-shaped braiding shape bracket.
Fig. 9 is the schematic diagram for indicating three bridges, six peak Z-shaped braiding shape structure stand.
Figure 10 is the planar development schematic diagram for indicating three bridges, seven peak Z-shaped braiding shape bracket.
Figure 11 is the plane outspread drawing for indicating braiding shape and bridge bracket.
Figure 12 is the plane outspread drawing for indicating 90 ° of circular arc braiding shape brackets.
Figure 13 is the plane outspread drawing for indicating 115 ° of circular arc braiding shape brackets.
Figure 14 is the plane outspread drawing for indicating splicing circular arc braiding shape bracket.
Figure 15 is the plane outspread drawing for indicating arc-shaped double chamfering brackets.
Figure 16 is to indicate radially to try hard to according to intravascular stent measured by Fig. 2, Fig. 3, Fig. 5, supporting structure shown in fig. 6.
Figure 17 is to indicate radially to try hard to according to intravascular stent measured by Fig. 7, Fig. 8, Fig. 9, supporting structure shown in Fig. 10.
Figure 18 is to indicate radially to try hard to according to intravascular stent measured by Figure 12, Figure 13, supporting structure shown in figure 15.
Mark meaning in Fig. 1-Figure 18 is as follows: arrow: expression wire route, and 1: starting point, 2: link position, 3a: empty
The structure that quasi- first lap wire is formed, 3b: the structure that first lap wire is formed, 4: the knot that the second virtual circle wire is formed
Structure, 1.: being transitioned into the lap that the second circle wire is formed from first lap wire, 2.: being transitioned into third circle from the second circle wire
The lap that wire is formed, 3. and 4.: during the second circle wire, forming bridging with the structure that first lap wire is formed
When the lap that is formed, A: six peaks zigzag structure shown in Fig. 2, B: eight peaks zigzag structure shown in Fig. 3, C: Fig. 5 institute
The six peaks braiding shape structure shown, D: six peak shown in fig. 6 closed loop weaves shape structure, E: eight peak shown in Fig. 7 closed loop weaves shape knot
Structure, F: two bridges, six peak Z-shaped shown in Fig. 8 weaves shape structure, G: three bridges, six peak Z-shaped braiding shape structure shown in Fig. 9, and H: Tu10Suo
Three bridges, the seven peak Z-shaped braiding shape structure shown, 90 ° of circular arcs shown in I: Figure 12 weave shape structure, 115 ° of circular arcs shown in J: Figure 13
Weave shape structure, K: arc-shaped double chamfering structures shown in figure 15.
Specific embodiment
For a better understanding of the present invention, in conjunction with attached drawing, invention is further explained:
Embodiment 1.1:
A kind of degradable polymer bracket uses PLLA as raw material, and the molecular weight of PLLA is 800,000, using Z-shaped in the same direction
Shape processing route, specific procedure of processing are as follows:
1) use the structure of computer program design intravascular stent for cylinder；
2) according to the intravascular stent structure of design, automatic or manual generates intravascular stent processing program；
3) extruder operating parameter is set, and waiting facilities reach setup parameter value；
4) by PLLA pellet be added equipment feed bin in, extruder according to the wiring path set in the control system according to
It is secondary to squeeze out fiber to prepare the degradable blood vessel bracket；
5) intravascular stent of extrusion is used for subsequent pressure and holds process.
The PLLA bracket being prepared is cylindrical stent, and having a size of 6 × 40mm, PLLA bracket obtained is used as periphery
Intravascular stent, supporting structure are six peak zigzag structure A, and expanded schematic diagram is as shown in Fig. 2, wherein lap is as shown in figure 1
1., 2., 3. and 4. shown in.In the present embodiment, structure 3a that first lap wire is formed along the virtual first lap wire in Fig. 1
The arrow path in left side is waken up with a start, and is carried out since starting point 1, after first lap wire, forms the knot that first lap wire is formed
Structure 3b；Then extruder returns to starting point 1, and wire is carried out from starting point 1 to link position 2, forms what first lap wire was formed
Structure and second circle wire formed structure between bridging and form lap 1.；Second circle wire is first along from virtual
Second circle wire formed 4 starting point 1 of structure to link position 2 path carry out, reach link position 2 after, extruder along
The right side arrow path for the structure 4 that the second virtual circle wire is formed carries out, and in the process, formation is formed with first lap wire
Structure bridging, 3. and 4. and form lap in bridging position；After the second circle wire, extruder returns to first
The company for the structure that the bridging and the second circle wire enclosed between the structure that the circle wire of structure 3b and second that wire is formed is formed is formed
Position 2 is connect, the arrow on 4 right side of structure formed along the second virtual circle wire carries out wire, forms the second circle wire and is formed
Structure and third circle wire formed structure between bridging and form lap 2..
Embodiment 1.2, a kind of degradable polymer bracket, with embodiment 1.1, the difference is that: the ruler of intravascular stent
Very little 6 × 60mm.
Embodiment 1.3, a kind of degradable polymer bracket, with embodiment 1.1, the difference is that: the ruler of intravascular stent
Very little 6 × 80mm.
Embodiment 1.4, a kind of degradable polymer bracket, with embodiment 1.1, the difference is that: the ruler of intravascular stent
Very little 6 × 100mm.
Embodiment 1.5, a kind of degradable polymer bracket, with embodiment 1.1, the difference is that: the ruler of intravascular stent
Very little 6 × 120mm.
Embodiment 2.1: a kind of family of degradable polymer, with embodiment 1.1, the difference is that: the branch being prepared
Frame is eight peak zigzag structure B, and flat deployable structure is as shown in Figure 3.
Embodiment 3.1: a kind of degradable polymer bracket, with embodiment 1.1, the difference is that: preparing bracket
In the process, intravascular stent being prepared using reversed zigzag processing route, preparation-obtained bracket is six peak closed loop zigzag structures,
As shown in figure 4, the bridge joint straight line of this structure is short and small, it is higher to preparation required precision.
Embodiment 3.2.1: a kind of degradable polymer bracket, with embodiment 1.1, the difference is that: preparing bracket
During, intravascular stent is prepared using braiding processing route, the intravascular stent of preparation is that six peaks weave shape structure C, plane
Expanded schematic diagram is as shown in Figure 5.
Embodiment 3.2.2: a kind of degradable polymer bracket, with embodiment 3.2.1, the difference is that: by bracket two
The opening mode at end is designed to six ring honeycomb structures, forms it into six peak closed loops braiding shape structure D, planar development schematic diagram is such as
Shown in Fig. 6.The pressure that such bracket can control bracket in pressure grip ring section holds elongation；Meanwhile the both ends of braiding structure introduce
Honeycomb structure is conducive to the raising of bracket mechanical property.
Embodiment 3.2.3: a kind of degradable polymer bracket, with embodiment 3.2.2, the difference is that: the branch of preparation
Frame is eight peak closed loops braiding shape structure E, as shown in Figure 7.
Embodiment 3.3.1: a kind of degradable polymer bracket, with embodiment 1.1, the difference is that: preparing bracket
During, intravascular stent is prepared using Z-shaped braiding processing route, structure is as shown in Figure 8.Bracket in the present embodiment is still
Zigzag structure is remain, bridging number is two bridges, and the number at peak is seven peaks, i.e., the nail structure in the present embodiment is two bridges six
Peak Z-shaped weaves shape structure G.
Embodiment 3.2.4: a kind of degradable polymer bracket, with embodiment 3.2.1, the difference is that: the branch of preparation
Frame is three bridges, six peak Z-shaped braiding shape structure G, as shown in Figure 9.
Embodiment 3.3.2: a kind of degradable polymer bracket, with embodiment 3.3.1, the difference is that: it is prepared
Bracket be three bridges, seven peak Z-shaped weave shape structure H, as shown in Figure 10.
Embodiment 3.3.4: a kind of degradable polymer bracket, with embodiment 3.3.1, the difference is that: it is prepared
Bracket be four bridges, eight peak structure.
Embodiment 3.3.5: a kind of degradable polymer bracket, with embodiment 3.3.1, the difference is that: it is prepared
Bracket be two bridges, eight peak structure.
Embodiment 3.3.4: a kind of degradable polymer bracket, with embodiment 3.3.1, the difference is that: it is prepared
Bracket be three bridges, eight peak structure.
Embodiment 3.2.5: a kind of degradable polymer bracket, with embodiment 3.2.1, the difference is that: the branch of preparation
Frame is braiding shape and bridge structure, also referred to as bridging parallel organization, and as shown in figure 11, the rack surface in the present embodiment is more evenly.
Embodiment 3.4.1: a kind of degradable polymer bracket, with embodiment 3.3.1, the difference is that: in preparation branch
During frame, intravascular stent is prepared using arc-shaped braiding processing route, the dog-ear peak of bracket is made to become fillet peak.This implementation
Fillet peak is 90 ° of circular arcs in example, and bracket obtained is 90 ° of circular arc braiding structure I, and in the present embodiment, bridging number is three, peak
Number is six peaks, as shown in figure 12.
Embodiment 3.4.2: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: preparation process
Middle circular arc radian is 115 °, and the bracket of preparation is 90 ° of circular arc braiding structure J, and in the present embodiment, bracket is three bridges, six peak, is such as schemed
Shown in 13.
Embodiment 3.4.3: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: preparation process
Middle circular arc radian is 120 °.
Embodiment 3.4.4: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: preparation process
Middle circular arc is 90 ° and 105 ° splicing circular arcs, and the supporting structure of preparation is as shown in figure 14.
Embodiment 3.4.5: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: preparation process
In, chamfering is added on the straight line both sides of same bridging connecting place, still keeps arc structure in bracket left end and right end, is not added
Enter chamfering.In the present embodiment, supporting structure is arc-shaped double chamfering structures, as shown in figure 15.From Figure 15, it can be seen that branch
Frame is three bridges, six peak structure, and the position of each bridging is provided with double chamferings.
Embodiment 4.1: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: in the present embodiment,
The raw material for preparing the Biodegradable scaffold are l-lactic acid (PLLA) and polylactic acid (PLA).
Embodiment 4.2: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: in the present embodiment,
The raw material for preparing the Biodegradable scaffold are l-lactic acid (PLLA), polylactic acid (PLA) and polyethylene glycol (PEG).
Embodiment 4.3: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: in the present embodiment,
Prepare the Biodegradable scaffold raw material be l-lactic acid (PLLA), polylactic acid (PLA), polyethylene glycol (PEG) and
Fumaric acid.
Embodiment 4.4: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: in the present embodiment,
The raw material of the Biodegradable scaffold are prepared as l-lactic acid (PLLA), polylactic acid (PLA), polyethylene glycol (PEG), richness
Horse acid and polycaprolactone polycaprolactone (PCL).
Embodiment 4.5: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: in the present embodiment,
The raw material of the Biodegradable scaffold are prepared as l-lactic acid (PLLA), polylactic acid (PLA), polyethylene glycol (PEG), richness
Horse acid, polycaprolactone polycaprolactone (PCL) and poly- (beta-hydroxy-butanoic acid ester).
Embodiment 4.6: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: in the present embodiment,
The raw material of the Biodegradable scaffold are prepared as l-lactic acid (PLLA), polylactic acid (PLA), polyethylene glycol (PEG), richness
Horse acid, polycaprolactone polycaprolactone (PCL), poly- (beta-hydroxy-butanoic acid ester) and polyethylene glycol hydroxyacetic acid (PGA).
Embodiment 4.7: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: in the present embodiment,
The raw material of the Biodegradable scaffold are prepared as l-lactic acid (PLLA), polylactic acid (PLA), polyethylene glycol (PEG), richness
Horse acid, polycaprolactone polycaprolactone (PCL), poly- (beta-hydroxy-butanoic acid ester), polyethylene glycol hydroxyacetic acid (PGA) and poly- (Asia
The DTH of amino carbonic acid).
Embodiment 4.8: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: in the present embodiment,
The raw material of the Biodegradable scaffold are prepared as l-lactic acid (PLLA), polylactic acid (PLA), polyethylene glycol (PEG), richness
Horse acid, polycaprolactone polycaprolactone (PCL), poly- (beta-hydroxy-butanoic acid ester), polyethylene glycol hydroxyacetic acid (PGA), poly- (Asia
The DTH of amino carbonic acid) and polydioxanone.
Embodiment 4.9: a kind of degradable polymer bracket, with embodiment 3.4.1, the difference is that: in the present embodiment,
The raw material for preparing the Biodegradable scaffold are the mixture of l-lactic acid (PLLA) and hydroxyapatite.
Embodiment 4.10: with embodiment 1.1, the difference is that: in the present embodiment unlike, raw material be PLLA and
The mixture of tricalcium phosphate.
Embodiment 4.11: with embodiment 1.1, the difference is that: the present embodiment chinese raw materials be PLLA, PLA, hydroxyl phosphorus
The mixture of lime stone, ethylene glycol and polycaprolactone, wherein ethylene glycol and polycaprolactone are as coating.
Embodiment 5.1: with embodiment 1.1, the difference is that: the raw material in the present embodiment be molecular weight be 500,000
PLLA。
Embodiment 5.2: with embodiment 1.1, the difference is that: the raw material in the present embodiment be molecular weight be 400,000
PLLA。
Embodiment 5.3: with embodiment 1.1, the difference is that: the raw material in the present embodiment be molecular weight be 200,000
PLLA。
Embodiment 5.4: with embodiment 1.1, the difference is that: the raw material in the present embodiment be molecular weight be 650,000
PLLA。
The mechanical property of bracket
No matter by the design of any processing route, after supporting structure prepares, it is also necessary to test mechanical property
It can be to determine qualified products.The intravascular stent pressure prepared is held on sacculus in advance, after being strutted in 37 ± 5 DEG C of water temperature,
It is measured with radial force tester.Shown in Figure 16-18, Figure 16 shows shown in Fig. 2 for its radial force and the relationship of diameter
Six peak zigzag structure A, zigzag structure B in eight peaks shown in Fig. 3, six peak shown in fig. 5 weave shape structure C and shown in fig. 6 six
Peak closed loop weaves the diameter of tetra- kinds of brackets of shape structure D and the relation schematic diagram of radial force, and Figure 17 shows that eight peak shown in Fig. 7 closes
Ring weaves shape structure E, two bridge shown in Fig. 8, six peak Z-shaped braiding shape structure F, three bridge shown in Fig. 9, six peak Z-shaped and weaves shape structure G
With the diameter of three bridges, seven peak Z-shaped shown in Fig. 10 braiding tetra- kinds of brackets of shape structure H and the relation schematic diagram of radial force, Figure 18 is shown
115 ° of circular arcs braiding shape structure J and circular arc shown in figure 15 shown in 90 ° of circular arcs braiding shape structure Is, Figure 13 shown in Figure 12
The diameter of tri- kinds of brackets of double chamfering structure K and the relation schematic diagram of radial force.In following table, various types bracket is listed
The average circumferential intensity (N/cm) obtained after test, can be seen that from the data in table and gathers as prepared by this kind of method
Closing object intravascular stent is integrally radial support power with higher, especially to process road almost without the arc-shaped braiding occurred
Line has more advantage.
| Supporting structure type | Average circumferential direction intensity (N/cm) |
| Fig. 2 | 1.756±0.593 |
| Fig. 3 | 0.868±0.186 |
| Fig. 5 | 0.956±0.091 |
| Fig. 6 | 1.133±0.103 |
| Fig. 7 | 1.195±0.004 |
| Fig. 8 | 0.785±0.051 |
| Fig. 9 | 1.550±0.317 |
| Figure 10 | 0.792±0.128 |
| Figure 12 | 1.286±0.241 |
| Figure 13 | 1.923±0.217 |
| Figure 15 | 2.251±0.236 |
It, can be according to different materials due to being respectively to squeeze different materials on rotating rod for combined support
Corresponding optimal parameter is respectively set in different characteristics, makes its best performance, so, the mechanical experimental results are equally applicable
In the other materials or mixture or copolymer.
The above is only a preferred embodiment of the present invention, the present invention is not limited to this, it is noted that for this technology
For the those of ordinary skill in field, without departing from the technical principles of the invention, several improvement and change can also be made
Type, these improvements and modifications also should be regarded as protection scope of the present invention.
Claims (27)
1. a kind of method that processing prepares degradable in vivo bracket, comprising the following steps:
1) structure of computer program design bracket is used；
2) according to the supporting structure of design, automatic or manual generates bracket processing program；
3) extruder operating parameter is set, and waiting facilities reach setup parameter value；
4) pellet is added in the feed bin of equipment, extruder can be sequentially extruded fiber according to the wiring path set in control system
To prepare the biodegradable stent, the wiring path of the setting includes that zigzag processing route in the same direction, reversed zigzag add
Work route, braiding shape processing route, the braiding structure processing route of closed loop, Z-shaped braiding shape processing route and arc-shaped braiding add
Work route, the arc-shaped braiding processing route is the line for being arranged to processing route to have certain radian, or, and in same bridging
Chamfering is added in the straight line of connecting place, and the bracket of preparation is made to become the double chamfering structures of circular arc；
5) intravascular stent of extrusion is used for subsequent pressure and holds process.
2. the method according to claim 1, wherein in step 4, the pellet is biodegradable high score
Sub- material.
3. the method according to claim 1, wherein in step 4, the pellet is Biodegradable high-molecular
The mixture of material and other nonmetallic materials or auxiliary agent, other described nonmetallic materials are hydroxyapatite, in tricalcium phosphate
One or more kinds of mixtures.
4. according to the method described in claim 3, it is characterized in that, the auxiliary agent includes substance and/or the development as coating
Agent.
5. according to the method described in claim 4, it is characterized in that, the substance as coating includes polyethylene glycol, gathers oneself
One of lactone, polyvinylpyrrolidone or more than one mixtures.
6. according to the method described in claim 4, it is characterized in that, the developer includes one of gold, wolfram element or one
Kind or more mixture.
7. the method according to claim 1, wherein the practical tendency of zigzag processing route in the same direction is a ring
One ring carries out, and the second ring trend is carried out after the first ring, is all the lap annular in shape in rotation, structure to product
Final performance has adjustment effect, and the main part of bracket is by zigzag straight line and the short-term group being connected between two zigzag straight lines
At the zigzag straight line of each column is same direction, i.e. peak to peak, and paddy is to paddy；Each column bridge joint straight line number it is identical and successively between
Every.
8. the method according to claim 1, wherein the zigzag of the reversed each column of zigzag processing route with
The straight line zigzag of previous column forms the honey comb like hexagonal structure of closed loop or semiclosed loop at reversed arrangement.
9. the method according to claim 1, wherein the braiding shape processing route is then the beginning of bracket preparation
In the same side, non-overlapping path occurs for end and end, bracket can be supported open loop structure or closed loop configuration.
10. the method according to claim 1, wherein Z-shaped braiding shape processing route is then whole wire
Mode is Z-shaped braiding, still remains zigzag structure, and bracket Z-shaped straight line portion on supporting structure prepared by wire mode
It is not overlapped, only has overlapping in the place of bridging.
11. a kind of Biodegradable scaffold, which is characterized in that the Biodegradable scaffold is using side as described in claim 1
Method preparation.
12. Biodegradable scaffold as claimed in claim 11, which is characterized in that the material for preparing the bracket is polylactic acid
(PLA), l-lactic acid (PLLA), polyethylene glycol hydroxyacetic acid (PGA), polycaprolactone polycaprolactone (PCL), poly- second
Glycol (PEG), polyanhydride, poly- (beta-hydroxy-butanoic acid ester), polydioxanone, poly- (DTH of iminocarbonic acid), polypropylene,
Fumaric acid one or more of mixture or copolymer.
13. Biodegradable scaffold as claimed in claim 11, which is characterized in that the Biodegradable scaffold is to have an axis
The 3D shape of line.
14. Biodegradable scaffold as claimed in claim 13, which is characterized in that the Biodegradable scaffold is cylinder
Shape.
15. Biodegradable scaffold as claimed in claim 11, which is characterized in that the internal structure of the bracket is in zigzag
And/or the double chamfering structures of braiding shape structure, arc-shaped structure, circular arc, braiding and bridge structure.
16. Biodegradable scaffold as claimed in claim 11, which is characterized in that the intravascular stent surface spraying cell is raw
Long to inhibit drug, the cell growth inhibition drug is taxol and/or rapamycin.
17. Biodegradable scaffold as claimed in claim 11, which is characterized in that the zigzag and/or braiding shape structure are
Six peaks, seven peaks or eight peak structures.
18. Biodegradable scaffold as claimed in claim 11, which is characterized in that the zigzag and/or braiding shape structure are
Open loop or closed loop configuration.
19. Biodegradable scaffold as claimed in claim 11, which is characterized in that the zigzag structure be zigzag in the same direction or
Reversed zigzag structure.
20. Biodegradable scaffold as claimed in claim 11, which is characterized in that the circular arc of the arc-shaped structure is 90 °
Or 115 ° or 120 ° or for splicing circular arc.
21. the braiding of Biodegradable scaffold as claimed in claim 11 and bridge structure, which is characterized in that the braiding and bridge
Structure is two bridges, six peak structure, eight peak structure of three bridges, six peak structure, three bridges, seven peak structure or four bridges.
22. Biodegradable scaffold as claimed in claim 11, which is characterized in that the Biodegradable scaffold outer diameter
For 5-8 mm.
23. Biodegradable scaffold as claimed in claim 11, which is characterized in that the circumferential direction of the Biodegradable scaffold is strong
Degree is 0.7-3.0 N/cm.
24. a kind of peripheral vascular stents, which is characterized in that the peripheral vascular stents are using biology as claimed in claim 15
Biodegradable stent.
25. peripheral vascular stents as claimed in claim 24, which is characterized in that the internal stent structure is zigzag structure
And/or braiding shape structure, circular arc braiding structure and the double chamfering structures of circular arc.
26. peripheral vascular stents as claimed in claim 24, which is characterized in that surface is coated with cell growth inhibition drug,
The cell growth inhibition drug is taxol and/or rapamycin.
27. peripheral vascular stents as claimed in claim 24, which is characterized in that its outer diameter is 5-8 mm, length 20-
120 mm。
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| CN105877881A (en) * | 2015-03-03 | 2016-08-24 | 周玉杰 | Method for preparing personalized bionic drug eluting coronary stent by using 3D printing technology |
| CN105288747B (en) * | 2015-11-27 | 2019-03-05 | 西华大学 | Carry the polylactic acid biological support and preparation method thereof of curcumin |
| JP2019517869A (en) * | 2016-06-03 | 2019-06-27 | 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 | Stent |
| CN106214296A (en) * | 2016-08-16 | 2016-12-14 | 华南农业大学 | A kind of 3D of utilization printing technique prepares method and the goods thereof of blood vessel support |
| CN109963527B (en) * | 2016-12-16 | 2021-12-24 | 北京阿迈特医疗器械有限公司 | Biodegradable thrombus filter, preparation method, application and conveying device thereof |
| US10870235B2 (en) * | 2018-04-24 | 2020-12-22 | Xerox Corporation | Method for operating a multi-nozzle extruder using zig-zag patterns that provide improved structural integrity |
| CN108641074B (en) * | 2018-05-23 | 2021-01-29 | 重庆大学 | Biodegradable material and preparation method and application thereof |
| CN109876198A (en) * | 2019-03-18 | 2019-06-14 | 吉林大学中日联谊医院 | A kind of angiocarpy bracket |
| WO2022000322A1 (en) * | 2020-06-30 | 2022-01-06 | 北京阿迈特医疗器械有限公司 | Developing composite material and preparation method therefor and use thereof, and implantable and interventional medical instrument and preparation method therefor |
| CN115976730A (en) * | 2023-03-21 | 2023-04-18 | 北京爱霖医疗科技有限公司 | Support, weaving method thereof and weaving mould |
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| CN102284086A (en) * | 2010-06-19 | 2011-12-21 | 宛新建 | Preparation method of biodegradable bracket for litholytic therapy of bile duct calculus |
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| CN102284086A (en) * | 2010-06-19 | 2011-12-21 | 宛新建 | Preparation method of biodegradable bracket for litholytic therapy of bile duct calculus |
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