CN108273142A - A kind of preparation method of the controllable degradable plugging device of degradation rate - Google Patents
A kind of preparation method of the controllable degradable plugging device of degradation rate Download PDFInfo
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- CN108273142A CN108273142A CN201810237385.1A CN201810237385A CN108273142A CN 108273142 A CN108273142 A CN 108273142A CN 201810237385 A CN201810237385 A CN 201810237385A CN 108273142 A CN108273142 A CN 108273142A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00831—Material properties
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
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Abstract
The invention discloses a kind of preparation methods of the controllable degradable plugging device of degradation rate, the degradable plugging device includes silk material and choked flow film, it is characterized in that, increase biocompatible coating using on the surface of silk material, barrier silk material is contacted with water, delay its mechanical property to reduce speed and degradation rate, just can start gradually to degrade after complete endothelialization in human body；Or it is introduced into any one or a few in the group that can promote endothelialization speed, peptide bond, growth factor and drug on the surface of silk material and choked flow film, endothelialization is completed faster after so that plugging device is implanted into.The degradable plugging device prepared using the present invention keeps the degradation speed of plugging device controllable, slow down the degradation speed of degradable plugging device, when it is applied to heart diaphragm, just start to degrade after can ensure that heart diaphragm endothelialization, avoids plugging device the early fallout or fragment embolism the problems such as.
Description
Technical field
The present invention relates to a kind of preparation methods of the controllable degradable plugging device of degradation rate, belong to medical device technology neck
Domain.
Background technology
There are three types of mechanical states for amorphous state polymers, they are glassy state, elastomeric state and viscous state.In glass transition temperature
TgHereinafter, high polymer is in glassy state, it is rigid solid, very small deformation only can occurs under external force；In melting temperature
Spend TmMore than, high polymer is in viscous state, and material gradually becomes the fluid of viscosity, and deformation at this time can not possibly restore；In vitrifying
Transition temperature TgMore than, melting temperature TmHereinafter, high polymer is in elastomeric state, the amount of elastic deformation of material significantly increases, and
This temperature range deformation is stablized relatively.It is exactly that they are utilized to be showed in elastomeric state that many high molecular materials, which have super-elasticity,
Excellent properties out.
Traditional plugging device is used to be woven with the NiTi B alloy wires of super-elasticity and shape memory, and metal material is most
Big disadvantage is exactly non-degradable, postoperative the problems such as there are arrhythmia cordis, block, Ni ion releasings, valve damages.Implantation
Patient need to carry all the life after patient's heart, and still lacking data to the Long-Term Safety of human body supports.Especially children, heart also exist
Constantly development, there are no the proofs of long term follow-up data for the Long-Term Safety of plugging device.
Currently, the biodegradable material for being usually used in making degradable plugging device includes mainly：Polylactic acid series (PLA classes,
Degradation curves of the Poly L-lactic acid PLLA in buffer solution is as shown in Figure 2), polydioxanone (PDO), polyglycolic acid
(PGA, degradation curves of the polyglycolic acid PGA in buffer solution are as shown in Figure 3), polycaprolactone (PCL), poly butyric ester
(PHB) etc..The glass transition temperature (Tg) of PDO high molecular materials is about -10 DEG C, and relatively low, melting temperature (Tm) is about 100
DEG C, therefore elastomeric state is under room temperature condition (20 DEG C or so), and it is softer, it is conducive to braiding.PPO is crystalline polymer, knot
For brilliant degree 37% or so, fusing point is about 110 DEG C, the property such as big, knot strength of strength retention ratio in tensile strength, degradation process
It can all preferably.Although and PLA class material good biocompatibilities, excellent in mechanical performance, degradation cycle are slow, glass transition temperature
Degree (Tg) is slightly higher at 50~60 DEG C, therefore is in glassy state at ambient temperature, harder, is unfavorable for weaving, in degradable neck
It is used as tubing in the application of domain more, shapes after being processed to it by the weaving of laser cutting, such as biodegradable stent.PGA class materials,
Glass transition temperature is 35 DEG C or so, flexible poor, although crystallinity is high, easy moisture absorption degradation, not easy to maintain in air,
Degradation rate is very fast, and implanting tissue starts to absorb after 15 days, is largely absorbed after 30 days, fully absorbs within 60~90 days, mechanical performance
Lose very fast, unsuitable making plugging device (degradation curve of the polyglycolic acid in buffer solution is as shown in Figure 3).Polycaprolactone
(PCL) glass transition temperature is low, is -60 DEG C, and material is soft, but degradation cycle is long, and degradation is very slow.In 1 year only
Molecular weight reduces, and 2 years or so materials start to be degraded to fragment, and 3~5 years degradable.As shown in Figure 1, for PCL in rat body
Molecular weight changes with time data drawing list.
PDO/PPDO poly (p-dioxanone) are the abbreviations of polydioxanone.In late 1970s by U.S.
Ethicon companies of state develop the surgical sewing thread of trade name PDS, it is monofilament structure, and special surface texture makes
Its damage to wound it is small, degradation property is good, flexibility be higher than other poly- GA sutures, have unique superiority.
The degradation of PDO is a hydrolytic process, and the speed of hydrolysis depends in part on the difficulty or ease journey of hydrone and ester bond effect
Degree.PDO fiber degradations it is more gentle, can keep a preferable intensity at degradation initial stage.With the progress of hydrolysis, material
Amorphous area and orientation texture are destroyed, and the strength of materials drastically declines, and to the last crystalline region is degraded.PDO is in human body
Interior to resolve into carbon dioxide and water completely, no chemical residues are widely used in sunkening cord for medical and beauty treatment and are promoted in art.
Currently, the material that the degradable plugging device of Shanghai Form Memory Alloy Materials Co., Ltd's research and development uses is mainly：
1. weaving silk material (polydioxanone PDO), 2. choked flow films (polylactic acid PLA class).
PDO plugging devices have lost mechanical strength at 3 months or so, and start to degrade.And heart diaphragm endothelialization
1-3 months are needed, this is possible to cause plugging device the early fallout or fragment embolism the problems such as.
Although current animal (animal model is beasle dog) experimental result shows that degradable plugging device is implanted into 1 month endothelium
Change and start, endothelialization is complete after 3 months, and 6 months plugging device obvious degradations, plugging device is degraded substantially within 12 months, seals within 2~3 years
Stifled device degradation is complete.But the endothelialization speed of animal is faster than human body, although endothelialization is complete in 3 months animal hearts
Entirely, but in human body the longer time may be needed.If the endothelialization of plugging device does not complete also after 3 months, and plugging device mechanical property
It can decline rapidly, support force reduces, and PDO silk materials start to degrade.Under the washing away of cardiac flow, the fracture of plugging device silk material, degradation
Fragment falls off, and may cause thrombus, leads to pulmonary embolism even cerebral infarction.
How to control and woven by silk material of the degradable sutures of PDO, is the degradable plugging device of choked flow film in body using PDLLA
Interior degradation rate is a urgent problem to be solved.
In view of the biocompatibility of material, degradability, stitchability, can constancy, the performances such as shape memory, with
For degradable suture PDO as silk material, the degradable plugging device of braiding is the ideal making material of current engineering technology angle
Material.
Although results of animal shows that the degradation rate of the degradable plugging devices of PDO matches with endothelialization speed,
The endothelialization speed of human body is slow compared with animal, it is thus possible to which there are plugging devices to have begun to degrade and the still incomplete wind of endothelialization
Danger may cause plugging device degradation fragment to be washed away by blood flow in heart and fall off, cause thrombus etc..
Invention content
Problem to be solved by this invention is：The too fast problem of the degradation speed of existing degradable plugging device.
To solve the above-mentioned problems, the present invention provides a kind of preparation sides of the controllable degradable plugging device of degradation rate
Method, the degradable plugging device include silk material and choked flow film, which is characterized in that using the one of which of following methods or two kinds：
Method one：Increase biocompatible coating on the surface of silk material, barrier silk material is contacted with water, delays its mechanical property
Speed and degradation rate are reduced, just can start gradually to degrade after complete endothelialization in human body；
Method two：The surface of silk material and choked flow film introduce can promote the group of endothelialization speed, peptide bond, growth factor and
Any one or a few in drug completes endothelialization faster after so that plugging device is implanted into；
When using two methods, first implementation one, then implementation two.
Preferably, the method one is specially：In the degradable closure of surface dip-coating degradation cycle ratio of silk material and choked flow film
The biodegradable coating of device length.
It is highly preferred that the biodegradable coating is using polylactic acid, (good biocompatibility, degradation speed is slow, after being implanted into 6 months
Start to degrade, 3~5 years of degradable needs), polycaprolactone or organosilicon.On the one hand, these high molecular materials all have
Preferable biocompatibility, and degradation cycle is longer, on the other hand, one layer of high molecular guarantor is coated on degradable plugging device surface
Cuticula can make silk material not direct and contact with moisture, and the degradation principles of silk material predominantly hydrolyze.Meanwhile these high molecular materials
Degradation cycle it is long, even if silk material has begun to degrade, the polymeric membrane longer due to being surrounded by degradation cycle makes its drop
Solution product is wrapped, and cannot be fallen off, also be cannot be introduced into blood in the short time, not cause the risk of thrombus.Finally, exist
After complete endothelialization, the coating on plugging device surface starts to degrade plugging device, and the degradation fragment of the silk material of coat inside is made to release
It puts, since plugging device is wrapped up by endothelial cell, degradation fragment has been not present and has peeled off, has caused the risk of thrombus.
Preferably, the method two is specially：Endothelialization can be promoted fast in the surface modification or dip-coating of silk material and choked flow film
Any one or a few in the growth factor of degree, small peptide and albumen.
It is highly preferred that the growth factor is by being chemically or physically introduced into the surface of silk material and choked flow film,
Promote plugging device in the quick endothelialization of defect；The chemical method is：Functional group or chemical bond are introduced by chemical bond
Binding growth factor.
Further, the growth factor is EGF, FGF or PDGF.
It is highly preferred that the small peptide uses the small peptide of extracellular matrix functional protein, sticking for endothelial cell can be promoted,
Also it is avoided that the defect for being introduced directly into natural extracellular matrix ingredient.
Further, the small peptide is any one in non-specific polypeptide and specific polypeptide or two kinds；It is non-specific
Property polypeptide be RGD or YIGSR, such polypeptide can promote to include endothelial cell sticking in interior various kinds of cell type；Specificity
Polypeptide is REDV, CAG or SVVYGLR, these polypeptide alternatives promote sticking and extending for endothelial cell.Using such polypeptide
Surface modification, can the specific endothelialization for promoting material.Several polypeptides of use in conjunction or joint specific polypeptide with it is some other
Biological information molecule may is that the peptide modified ideal scheme for promoting cardiovascular implantation material endothelialization of the following application.
It is highly preferred that the albumen is laminin, by being chemically or physically introduced into silk material and resistance
Flow the surface of film.Laminin have endothelial cell specific binding site, can material be implanted into human body after quick endothelium
Change.
Preferably, the silk material is PDO silk materials, and the choked flow film is PDLLA films.
The degradable plugging device prepared using the present invention keeps the degradation speed of plugging device controllable, slows down degradable plugging device
Degradation speed, when being applied to heart diaphragm, it can be ensured that just start to degrade after heart diaphragm endothelialization, avoid plugging device and exist
The problems such as early fallout or fragment embolism.
Description of the drawings
Fig. 1 is that the molecular weight of PCL in rat body changes with time data drawing list；
Fig. 2 is degradation curve of the Poly L-lactic acid in buffer solution；
Fig. 3 is degradation curve of the polyglycolic acid in buffer solution.
Specific implementation mode
In order to make the present invention more obvious and understandable, it is hereby described in detail below with preferred embodiment.
Embodiment 1
PDO silk materials are woven, the degradable plugging device of suture PDLLA choked flow films is infiltrated to polycaprolactone (PCL), left-handed poly- breast
(PCL, PLLA, PDLLA are solute, chloroform, dichloromethane, hexafluoro isopropyl in the solution such as sour PLLA, poly-dl-lactide PDLLA
Alcohol is equal solvent), 10min is infiltrated, takes out in rear venting cupboard and dries, washing and sterilizing packaging, operation directly uses.
Embodiment 2
PDO silk materials are woven, the degradable plugging device washing and sterilizing packaging of suture PDLA choked flow films, operation consent dismantles packet
Dress, plugging device is infiltrated in the sterile saline dissolved with growth factors such as EGF, FGF or PDGF, and concentration is about 1%~
5%, infiltrating time is 3~10min.And the solution dissolved with growth factor is used to fill posterior exhaust solution as plugging device.
Embodiment 3
PDO silk materials are woven, in the degradable plugging device infiltration to the solution of polycaprolactone (PCL) of suture PDLLA choked flow films
(PCL is solute, and chloroform, dichloromethane, hexafluoroisopropanol are equal solvent), infiltrates 10min, takes out in rear venting cupboard and dry, clearly
Wash sterilization packaging.Plugging device is infiltrated in operating room and is dissolved with the growth factor for promoting endothelialization, polypeptide, egg by operation consent
In white sterile saline, concentration is about 1%~5%, and infiltrating time is 3~10min.And using dissolved with growth factor,
The solution of polypeptide, albumen etc. fills posterior exhaust solution as plugging device.
Claims (10)
1. a kind of preparation method of the controllable degradable plugging device of degradation rate, the degradable plugging device includes silk material and choked flow
Film, which is characterized in that using the one of which of following methods or two kinds：
Method one：Increase biocompatible coating on the surface of silk material, barrier silk material is contacted with water, delays the reduction of its mechanical property
Speed and degradation rate just can start gradually to degrade in human body after complete endothelialization；
Method two：Group, peptide bond, growth factor and the drug of endothelialization speed can be promoted by being introduced on the surface of silk material and choked flow film
In any one or a few, make plugging device be implanted into after complete endothelialization faster；
When using two methods, first implementation one, then implementation two.
2. the preparation method of the controllable degradable plugging device of degradation rate as described in claim 1, which is characterized in that the side
Method one is specially：In the long biodegradable coating of the degradable plugging device of surface dip-coating degradation cycle ratio of silk material and choked flow film.
3. the preparation method of the controllable degradable plugging device of degradation rate as claimed in claim 2, which is characterized in that it is described can
Coating of degrading uses polylactic acid, polycaprolactone or organosilicon.
4. the preparation method of the controllable degradable plugging device of degradation rate as described in claim 1, which is characterized in that the side
Method two is specially：It can promote growth factor, small peptide and the egg of endothelialization speed in the surface modification or dip-coating of silk material and choked flow film
Any one or a few in white.
5. the preparation method of the controllable degradable plugging device of degradation rate as claimed in claim 4, which is characterized in that the life
The long factor is by being chemically or physically introduced into the surface of silk material and choked flow film；The chemical method is：Pass through chemistry
Key introduces functional group or chemical bonds growth factor.
6. the preparation method of the controllable degradable plugging device of degradation rate as claimed in claim 5, which is characterized in that the life
The long factor is EGF, FGF or PDGF.
7. the preparation method of the controllable degradable plugging device of degradation rate as claimed in claim 5, which is characterized in that described short
Peptide uses the small peptide of extracellular matrix functional protein.
8. the preparation method of the controllable degradable plugging device of degradation rate as claimed in claim 7, which is characterized in that described short
Peptide is any one or two kinds in non-specific polypeptide and specific polypeptide；Non-specific polypeptide is RGD or YIGSR；Specifically
Property polypeptide be REDV, CAG or SVVYGLR.
9. the preparation method of the controllable degradable plugging device of degradation rate as claimed in claim 4, which is characterized in that the egg
It is in vain laminin, by the surface for being chemically or physically introduced into silk material and choked flow film.
10. the preparation method of the controllable degradable plugging device of degradation rate as described in any one of claims 1-9, feature
It is, the silk material is PDO silk materials, and the choked flow film is PDLLA films.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201810237385.1A CN108273142B (en) | 2018-03-21 | 2018-03-21 | Preparation method of degradable occluder with controllable degradation rate |
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| CN201810237385.1A CN108273142B (en) | 2018-03-21 | 2018-03-21 | Preparation method of degradable occluder with controllable degradation rate |
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Cited By (6)
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| CN109464168A (en) * | 2018-12-17 | 2019-03-15 | 先健科技(深圳)有限公司 | Plugging device |
| CN109464167A (en) * | 2018-12-11 | 2019-03-15 | 先健科技(深圳)有限公司 | Plugging device and preparation method thereof |
| CN109498074A (en) * | 2019-01-04 | 2019-03-22 | 上海形状记忆合金材料有限公司 | Method Wholly-degradable plugging device dedicated driving means and its connect with plugging device |
| CN113769177A (en) * | 2021-08-26 | 2021-12-10 | 四川大学 | Degradable occluder coating and preparation method thereof |
| CN114533969A (en) * | 2022-01-18 | 2022-05-27 | 深圳市儿童医院 | Preparation method and application of anti-streaming membrane for promoting endothelialization |
| CN115054307A (en) * | 2022-06-30 | 2022-09-16 | 上海微创医疗器械（集团）有限公司 | Occlusion implant and method for producing the same |
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| CN109498074A (en) * | 2019-01-04 | 2019-03-22 | 上海形状记忆合金材料有限公司 | Method Wholly-degradable plugging device dedicated driving means and its connect with plugging device |
| CN113769177A (en) * | 2021-08-26 | 2021-12-10 | 四川大学 | Degradable occluder coating and preparation method thereof |
| CN114533969A (en) * | 2022-01-18 | 2022-05-27 | 深圳市儿童医院 | Preparation method and application of anti-streaming membrane for promoting endothelialization |
| CN115054307A (en) * | 2022-06-30 | 2022-09-16 | 上海微创医疗器械（集团）有限公司 | Occlusion implant and method for producing the same |
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