CN109893311A - A kind of novel biodegradable stent and its manufacturing method - Google Patents
A kind of novel biodegradable stent and its manufacturing method Download PDFInfo
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- CN109893311A CN109893311A CN201811496884.9A CN201811496884A CN109893311A CN 109893311 A CN109893311 A CN 109893311A CN 201811496884 A CN201811496884 A CN 201811496884A CN 109893311 A CN109893311 A CN 109893311A
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- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention discloses a kind of novel biodegradable stents and its manufacturing method, it is related to implanted medical device field, including interior muscle, polymer substrate and medicine layer, the interior muscle is the wire under X-ray machine with developing function, the polymer substrate is mixed by polymer solution, it is wrapped in the wire periphery, forms solid, the polymer substrate with supporting role.The wire is twisted braiding in hollow numb flower type structure.The present invention combines two kinds of substrates, provides a kind of with good moulding, good radial support intensity, the bracket that can develop completely.The present invention also provides the manufacturing methods of the novel biodegradable stent.
Description
Technical field
The present invention relates to implanted medical device fields, more particularly to a kind of novel biodegradable stent and its manufacturing method.
Background technique
Bracket has obtained in cardiovascular disease field more and more wide as the important instrument for the treatment of hemadostewnosis
Using.For being now widely used for clinical metallic support, since it will permanently retain in human body after completing treatment task,
Weaken MRI coronarius or CT images so existing, interference surgery revascularization, the formation for hindering offshoot circulation, inhibit blood
The defects of pipe positivity is remolded.Based on these problems, Biodegradable scaffold is caused as a kind of possible substitution solution
The extensive concern of people.Biodegradable scaffold is made of degradable polymer material or metal material.In implantation lesion
Behind position, Biodegradable scaffold can play the role of support blood vessels in a short time, realize revascularization.Treatment complete with
Afterwards, the organic matter that Biodegradable scaffold can be degraded into human body environment can be absorbed by the body, be metabolized, the final bracket meeting
It disappears.Further, since bracket must will undergo the storage of regular period after the completion of preparation, bracket shelf life is short also to be will affect
The application of bracket.
The material of biodegradable stent generally comprises absorbable metal and polymer, polymer material autologous density very little, material
Expect that the radiopacit of itself is poor, the intravascular stent prepared with polymer is in medical imaging device and digital subtraction technology
It is almost invisible under auxiliary, cause in the course of surgery doctor bracket can not be accurately positioned, therefore polymer support need
Developing mechanism is additionally set, developing mechanism is enable to be identified at DSA by doctor.Pass through the development with good visibility
Structure makes up the deficiency of rest body visuality.
In order to solve the problems, such as that bracket is degradable, Chinese patent 2014108566258 proposes a kind of degradable iron-based conjunction
Golden bracket, but iron-based bracket due to the degradation speed of itself it is excessively slow, need to adulterate C, N, O, S, P, Mn, Pd, Si, W, Ti, Co,
At least one of Cr, Cu, Re can be doped into pure iron and form the medical ferrous alloy.And various polymerizations are added
Object accelerates its degradable, and catabolite complexity easily generates rejection with blood vessel.
In order to improve the radial support intensity of bracket, Chinese patent 2017112132378 propose a kind of polylactic acid and its
Copolymer bracket, it is height-oriented due to passing through radial direction, radial support intensity is improved, but bracket can be lost significantly simultaneously
Toughness, so that bracket is easily broken after through tortuous blood vessel.
For the developing performance for improving bracket, Chinese patent 2015103951018 proposes a kind of intravascular stent, in bracket table
Filling development object in face or structure, but can not accomplish that entire bracket develops completely
Therefore, those skilled in the art be dedicated to developing it is a kind of have good moulding, good radial support intensity, can
The bracket to develop completely.
Summary of the invention
In view of the above drawbacks of the prior art, a kind of with good modeling the technical problem to be solved by the present invention is to develop
Shape, good radial support intensity, the bracket that can develop completely use single substrate relative to traditional biodegradable stent, this
Invention combines two kinds of substrates, utilizes the good radial support of polymer, it is ensured that restenosis will not occur for bracket；It is utilized
The good moulding of wire guarantees that bracket is reached after lesion struts by tortuous blood vessel and will not be broken, reaches simultaneously
The purpose that entire bracket develops completely.
To achieve the above object, the present invention provides a kind of novel biodegradable stents, including interior muscle, polymer substrate
And medicine layer, which is characterized in that the interior muscle includes the wire under X-ray machine with developing function, the number of the wire
Amount is four or four or more, and the polymer substrate is mixed by polymer solution, is wrapped in the wire periphery,
Form the polymer substrate with support effect.
Further, the wire is one of ferrous alloy, magnesium base alloy, zinc-containing alloy and acieral.
Further, the cross section of the wire is cross.
Further, the wire is single-chamber metal tube, so that in the junction of the first base material and the second substrate
Portion is hollow structure.
Further, 10 times or more in the wire cross-sectional area of polymer substrate's cross-sectional area.
Further, the wire is twisted, braiding in hollow numb flower type structure, the hollow fried dough twist structure it is hollow
Structure is more one metal wires are wrapped in around a preformed polymer silk to be distorted and woven, braiding complete with
Afterwards, preformed polymer silk degradation removal is formed.
In addition, the present invention provides a kind of novel biodegradable stent manufacturing methods, which is characterized in that including following step
It is rapid:
Step 1 selects four or more the wires under X-ray machine with developing function as interior muscle, by described more
Wire is wrapped in around a preformed polymer silk, is formed a branch of；
Step 2 distorts the wire and the preformed polymer silk together, is woven into numb flower type structure；
Step 3 degrades the preformed polymer silk, after removing the preformed polymer silk, in fried dough twist type knot
Hollow structure is formed among structure, obtains muscle in hollow numb flower type structure；
Step 4, polymer solution is wrapped up on muscle surface in the hollow numb flower type structure, formed after solidifying it is solid,
With the molding polymer substrate of system；
Step 5 covers drug solution in the polymeric substrate layer surface, forms medication coat.
Further, in step 1, the wire is in ferrous alloy, magnesium base alloy, zinc-containing alloy and acieral
It is a kind of.
Further, in step 1, the cross section of the wire is cross.
Further, in step 1, the wire is single-chamber metal tube.
The beneficial effects of the present invention are: the present invention good plasticity of combination metal biodegradable stent with polymerize Biodegradable
The advantages of bracket good supportive, supportive is improved relative to metal biodegradable stent and is not susceptible to Restenosis；
Plasticity is improved relative to polymer biodegradable stent and is not susceptible to bracket fracture, and can be developed completely.Using hollow fried dough twist
Structure can make in later period polymer substrate's encapsulation process, and partial polymer can be embedded in fried dough twist structure, to increase
Add the firmness of package.Portion void is left in the course of surgery simultaneously, increases the plasticity and flexibility of biodegradable stent,
Be conducive to pass through pathological tissues.
It is described further below with reference to technical effect of the attached drawing to design of the invention, specific structure and generation, with
It is fully understood from the purpose of the present invention, feature and effect.
Detailed description of the invention
Fig. 1 is muscle top view in the hollow fried dough twist structure of a preferred embodiment of the invention；
Fig. 2 is muscle side view in the hollow fried dough twist structure of a preferred embodiment of the invention；
Fig. 3 is muscle oblique view in the hollow fried dough twist structure of a preferred embodiment of the invention；
The cross-sectional structure for the biodegradable stent of preferred embodiment Fig. 4 of the invention being made of four one metal wires shows
It is intended to.
Specific embodiment
Multiple preferred embodiments of the invention are introduced below with reference to Figure of description, keep its technology contents more clear and just
In understanding.The present invention can be emerged from by many various forms of embodiments, and protection scope of the present invention not only limits
The embodiment that Yu Wenzhong is mentioned.
In the accompanying drawings, the identical component of structure is indicated with same numbers label, everywhere the similar component of structure or function with
Like numeral label indicates.The size and thickness of each component shown in the drawings are to be arbitrarily shown, and there is no limit by the present invention
The size and thickness of each component.Apparent in order to make to illustrate, some places suitably exaggerate the thickness of component in attached drawing.
In following all examples, 1 material of wire for constituting interior muscle can be ferrous alloy, magnesium base alloy, zinc-base
Alloy, acieral etc., with the material of developing function, can also be cut by laser to obtain under X-ray machine by single-chamber metal tube,
Wire 1 can be to be single, can also more respective arrays.
Embodiment one
Fig. 1 show the hollow fried dough twist type assembled arrangement structure of muscle in more metals of a preferred embodiment of the invention and bows
View, wherein wire 21,2 therein, wire that wire 22 is four same cross-sectionals.Preformed polymer silk 23 is by four
In one metal wire (including wire 21, wire 22) is wrapped in, formed a branch of.Fig. 2 is this more interior hollow fried dough twist type groups of muscle
The side view of arrangement is closed, Fig. 3 is this more interior hollow fried dough twist type assembled arrangement oblique views of muscle, and more interior muscle are in hollow fried dough twist type group
Arrangement is closed, the toughness that fried dough twist type assembled arrangement can greatly improve bracket avoids bracket from being broken, but the meeting in flexibility
It is lacked.The present embodiment devises a kind of hollow fried dough twist type aligning method, and each wire is made to have independent activity
Space compensates for the missing in flexibility, specific implementation process are as follows:
Step 1 selects four or more the wires under X-ray machine with developing function as interior muscle, by described more
Wire (more one metal wires of the present embodiment be such as Fig. 1 21,22 totally four) is wrapped in a preformed polymer silk 23 weeks
It encloses, is formed a branch of；
Step 2 distorts the wire and the preformed polymer silk 23 together, is woven into numb flower type structure；
Step 3 degrades the preformed polymer silk 23, after removing the preformed polymer silk 23, in fried dough twist
Hollow structure is formed among type structure, obtains muscle in hollow numb flower type structure；
Step 4, polymer solution is wrapped up on muscle surface in the hollow numb flower type structure, formed after solidifying it is solid,
With the molding polymer substrate of system；
Step 5 covers drug solution in the polymeric substrate layer surface, forms medication coat.
Embodiment two
It is the straight frame cross section of four one metal wire respective arrays of another preferred embodiment of the invention shown in Fig. 4, can leads to
It crosses this embodiment and illustrates manufacturing process of the invention.Interior muscle is that identical four one metal wire of material model is respectively independent
Arrangement, wire 1 are ferrous alloy, magnesium base alloy, zinc-containing alloy, the acieral under X-ray machine with developing function；Four
One metal wire surrounding wrap up polymer solution formed polymer substrate 2, polymer solution PLLA, PDLLA, PDLA,
One of PLGA, PGLA, PLA, PDLGA or a variety of, by periphery package polymer solution formed it is solid, have support
The polymer substrate 2 of effect, so that wire 1 has good radial support, it is ensured that restenosis will not occur；Polymerization
2 periphery of object substrate layer is covered with the medicine layer 3 of drug and polymer solution mixing.
Wherein, polymer substrate 2 can be by spraying to obtain on 1 surface of wire, specific implementation process are as follows: will be described
It is organic molten that polymer solution is dissolved in one or more of methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform
Spray solution is formed in agent, sufficiently oscillation mixes, and covers with the spray rate of 0.01-0.06mm/min on 1 surface of wire
The spray solution of one layer of 10-15um thickness of lid, then dries 10min under 20-25 DEG C, 40-60%RH；Again on this surface
It is sprayed, repeatedly above-mentioned steps, until polymer solution covers 10 times or more of 1 cross-sectional area of wire；It will spray
The wire 1 for having applied the spray solution is sent into an oven, and vitrifying of the control temperature lower than the polymer solution material turns
10-20 DEG C of temperature is dried, and the polymer substrate 2 is formed.
Medicine layer 3 can be obtained by spraying drug solution on 2 surface of polymer substrate, specific implementation process
Are as follows: by the drug and the polymer solution be dissolved in methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, in chloroform
Drug solution is formed in one or more kinds of organic solvents, sufficiently oscillation mixes, with the spray rate of 0.01-0.03mm/min
The drug solution of one layer of 5-10um thickness is covered in the polymeric substrate layer surface, the polymeric substrate sprayed is sent into and is dried
In case, 10-20 DEG C of glass transition temperature for controlling temperature lower than drug solution material is dried, and forms the medicine layer 3.
Embodiment three
In the present embodiment, polymer substrate 2 can also be obtained by wire 1 described in dip-coating, specific implementation process are as follows:
The polymer solution is dissolved in one or more of methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform
Dip-coating solution is formed in organic solvent, sufficiently oscillation mixes；The wire 1 is immersed in the dip-coating solution, is taken after 1min
It dries out, 1180 ° of the wire is overturn after drying, the dip-coating solution is immersed in again, takes out and dry after 1min, guarantee
The dip-coating solution coating at 1 both ends of wire is uniform；Coating thickness is 15-25um, positive and negative to be denoted as a circulation twice；So
10min is dried under 20-25 DEG C, 40-60%RH afterwards；It steps be repeated alternatively until that the wire 1 of dip-coating solution covering is horizontal
Area of section is in 0.01mm2To 0.04mm2Between；The wire 1 of the dip-coating dip-coating solution is sent into baking oven, controls temperature
10-20 DEG C of glass transition temperature lower than the polymer solution material is dried, and the polymer substrate 2 is formed.
In addition, polymer substrate 2 can also be obtained by wire 1 described in 3D printing.
Medicine layer 3 can also be obtained by polymer substrate 2 described in dip-coating, specific implementation process are as follows: by the drug
One or more of methanol, ethyl alcohol, isopropanol, acetone, tetrahydrofuran, acetonitrile, chloroform are dissolved in the polymer solution
Drug solution is formed in organic solvent, sufficiently oscillation mixes；The polymer substrate is immersed in the drug solution, 1min
It takes out and dries afterwards；180 ° of the polymer substrate are overturn after drying, the drug solution is immersed in again, is taken out after 1min
It dries, the drug solution coating for guaranteeing the polymer substrate both ends uniformly, is adjusted by controlling the concentration of drug solution
Otherwise the thickness of dip-coating, the bigger coating of concentration are thicker then thinner；The wire 1 of the dip-coating drug solution is sent into baking oven,
Temperature is controlled lower than the drug solution material 10-20 DEG C of glass transition temperature is dried, and the medicine layer 3 is formed.
In addition, medicine layer 3 can also be obtained by polymer substrate 2 described in 3D printing.
Example IV
Wire 1 can also choose metal hollow tubing.The wire 1 being made of metal hollow coffin can pass through 3D
The mode of laser cutting carries out on tubular material surface with the helix of axial direction or hollow out (hollow out shape in the radial direction
Shape can be circle, direction, polygon, various abnormity) cutting, achieve the purpose that reduce metal tube moment of flexure.Relative to metal
Silk material, Integral Moment are greatly reduced, and the flexibility of entire supporting structure will be substantially improved, and rear road polymeric substrate coats work
Polymer is entered in hollow tube by the processing gap being cut by laser on hollow tube in sequence, solidification post-consumer polymer substrate and gold
The cohesive strength belonged between substrate can be substantially improved.
The preferred embodiment of the present invention has been described in detail above.It should be appreciated that the ordinary skill of this field is without wound
The property made labour, which according to the present invention can conceive, makes many modifications and variations.Therefore, all technician in the art
Pass through the available technology of logical analysis, reasoning, or a limited experiment on the basis of existing technology under this invention's idea
Scheme, all should be within the scope of protection determined by the claims.
Claims (10)
1. a kind of novel biodegradable stent, including interior muscle, polymer substrate and medicine layer, which is characterized in that the interior muscle
Including, with the wire of developing function, the quantity of the wire is four or four or more, the polymer under X-ray machine
Substrate layer is mixed by polymer solution, is wrapped in the wire periphery, is formed the polymer with support effect
Substrate layer.
2. novel biodegradable stent as described in claim 1, which is characterized in that the wire is ferrous alloy, magnesium-based
One of alloy, zinc-containing alloy and acieral.
3. novel biodegradable stent as described in claim 1, which is characterized in that the cross section of the wire is cross
Shape.
4. novel biodegradable stent as described in claim 1, which is characterized in that the wire is single-chamber metal tube.
5. novel biodegradable stent as described in claim 1, which is characterized in that polymer substrate's cross-sectional area
At 10 times or more of the wire cross-sectional area.
6. novel biodegradable stent as described in claim 1, which is characterized in that the wire is twisted, during braiding is in
Empty fiber crops flower type structure, the hollow structure of the hollow fried dough twist structure are that more one metal wires are wrapped in a preformed polymer
It is distorted and is woven around silk, after braiding is completed, preformed polymer silk degradation removal is formed.
7. a kind of novel biodegradable stent manufacturing method, which is characterized in that the described method comprises the following steps:
Step 1 selects four or more the wires under X-ray machine with developing function as interior muscle, by the more metals
Silk is wrapped in around a preformed polymer silk, is formed a branch of；
Step 2 distorts the wire and the preformed polymer silk together, is woven into numb flower type structure；
Step 3 degrades the preformed polymer silk, after removing the preformed polymer silk, in numb flower type structure
Between form hollow structure, obtain muscle in hollow numb flower type structure；
Step 4, polymer solution is wrapped up on muscle surface in the hollow numb flower type structure, and formation is solid after solidifying, has
Make molding polymer substrate；
Step 5 covers drug solution in the polymeric substrate layer surface, forms medication coat.
8. the method for claim 7, which is characterized in that in step 1, the wire be ferrous alloy, magnesium base alloy,
One of zinc-containing alloy and acieral.
9. method according to claim 8, which is characterized in that in step 1, the cross section of the wire is cross.
10. the method for claim 7, which is characterized in that in step 1, the wire is single-chamber metal tube.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811496884.9A CN109893311B (en) | 2018-12-07 | 2018-12-07 | Degradable bracket and manufacturing method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811496884.9A CN109893311B (en) | 2018-12-07 | 2018-12-07 | Degradable bracket and manufacturing method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN109893311A true CN109893311A (en) | 2019-06-18 |
| CN109893311B CN109893311B (en) | 2023-06-30 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811496884.9A Active CN109893311B (en) | 2018-12-07 | 2018-12-07 | Degradable bracket and manufacturing method thereof |
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| CN109893311B (en) | 2023-06-30 |
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