CN108186162A - A kind of three-decker composite artificial blood vessel - Google Patents
A kind of three-decker composite artificial blood vessel Download PDFInfo
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- CN108186162A CN108186162A CN201711273150.XA CN201711273150A CN108186162A CN 108186162 A CN108186162 A CN 108186162A CN 201711273150 A CN201711273150 A CN 201711273150A CN 108186162 A CN108186162 A CN 108186162A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
Abstract
The invention discloses a kind of three-decker composite artificial blood vessels, belong to medical instruments field, which is made of fine and close resistance blood layer, elastomer layer and fiber-reinforced layer.Wherein, fine and close resistance blood layer is in the inner surface of tube body, and elastomer layer is in the centre of tube body, and fiber-reinforced layer is in the outer surface of tube body.Resistance blood layer, elastomer layer and fiber-reinforced layer are all distributed with micropore, and the size of micropore is in increase tendency from internal layer to outer layer.Resistance courage and uprightness energy, the tissue of each layer of artificial blood vessel grow into performance, antithrombotic property, mechanical strength and thickness and change in gradient：It can be in increase tendency from outer layer to internal layer to hinder courage and uprightness；It is in reduction trend from outer layer to internal layer that cell, which grows into performance,；Antithrombotic property is in enhancing trend from outer layer to internal layer；Mechanical strength is in reduction trend from outer layer to internal layer.The three-decker composite artificial blood vessel of the present invention has good permeability resistance, antithrombotic, compliance, biocompatibility and mechanical performance.
Description
Technical field
The invention belongs to medical instruments fields, more particularly to a kind of to have good permeability resistance, antithrombotic, comply with
The three-decker composite artificial blood vessel of property, biocompatibility and mechanical performance.
Background technology
Vascular system includes heart, blood vessel and blood.Fresh blood is transported body by heart through big and small blood vessel
Each position of body carries out the exchange of internal nutritional ingredient and waste, to ensure the normal function of each organ.However Atherosclerosis
The causes of disease such as change, hemangioma and external force wound cause multiple intra-arterial and vein blood vessel defect, need through surgical operation using different
The Vascular substitutes of diameter carry out the maintenances treatments such as corresponding lesion vessels site substitution, bridging.Vascular substitutes generally have self
Blood vessel, heterogenous blood vessel, allogeneic blood vessel and artificial blood vessel, since autologous vein is frequently subjected to patient age, already present blood
The limitation of the factors such as pipe disease and heterogenous blood vessel and allogeneic blood vessel carry out source problem, clinically need a large amount of artificial blood vessels
To carry out maintenance to lesion vessels.
Ideal artificial blood vessel, most basic performance should meet：（1）With certain intensity, it is not easy to tear when identical,
Blood pressure can be born during use without breakage；（2）With the compliance similar with human vas, previous anastomotic is not easy to form blood
Bolt；（3）With good buckle resistance；（4）Appropriate porosity and pore size are being conducive to maintain what plasma protein was formed
Pseudomembrane and while promote endothelial cell growth, should ensure that blood is non-leakage, does not lead to embolism due to deposition；（5）Well
Biology（Tissue and blood）Compatibility will not cause rejection.
The artificial blood vessel having been commercialized at present, all there are it is various the problem of.Expanded polytetrafluoroethylene graft, by
It is brittle in basis material, causes the easy oozing of blood of suture；Its tube wall aperture is too small, and histocyte grows into also limited.Terylene
（PET）Artificial blood vessel, inner surface is rougher, easily forms thrombus；Its tube wall aperture is larger, and also leakiness blood, PET blood vessels are general in art
Pre- blood coagulation or biological coating is taken to operate to avoid the problem that leaking blood in art.Multi-layer composite artificial blood vessel, such as GORE
ACUSEAL Vascular Graft（State's tool is noted into 20153462072）, the product internal layer and outer layer are all ePTFE, middle layer
It is the layer of silica gel with low blood, since the ePTFE apertures of ectonexine are smaller, cell is made to be difficult to be fully grown into tube wall, this limitation
Blood vessel prosthesis is merged with tissue.
Invention content
In order to overcome drawbacks described above, the object of the present invention is to provide a kind of three-decker composite artificial blood vessels.The present invention
By the use of fine and close resistance blood layer as the inner wall of artificial blood vessel, make not oozing of blood, and with good antithrombotic in artificial blood vessel art
Energy；By the use of elastomer as the middle layer of artificial blood vessel, make artificial blood vessel that there is good compliance and mechanical performance, using
It is unlikely to deform in the process or kinking angulation, and the plugging effect after pin puncture is also fine；It is knitted using what fibrous woven was processed
Outer layer of the object as artificial blood vessel makes artificial blood vessel have good suture strength, and larger aperture can make cell and tissue
Liquid three-dimensional is penetrated into vascular wall.Artificial blood vessel prepared by the present invention, good biocompatibility, oozing of blood, does not have good anti-blood
Bolt performance, compliance is good, and pin hole plugging effect is good, and suture strength is good, moreover it is possible to make cell realize three-dimensional grow into, make blood vessel prosthesis with
Autologous tissue merges.
In order to achieve the above-mentioned object of the invention, a kind of three-decker composite artificial blood vessel of the invention, it is characterised in that：People
Hematopoiesis pipe is made of fine and close resistance blood layer, elastomer layer, fiber-reinforced layer, wherein, fine and close hinders inner surface of the blood layer in tube body,
Elastomer layer all divides in the centre of tube body, fiber-reinforced layer in the outer surface of tube body, resistance blood layer, elastomer layer and fiber-reinforced layer
It is furnished with micropore, the size of micropore is from internal layer to outer layer in whole increase tendency.Wherein fine and close resistance blood layer is internal layer, elastomer layer
For middle layer, fiber-reinforced layer is outer layer.
Fine and close resistance blood layer is by expanded PTFE（ePTFE）, polytetrafluoroethylene (PTFE)（PTFE）Nanofiber, polyurethane
（PU）For one or more of nanofiber into being grouped as, several ingredients are respectively provided with good blood compatibility, and are not easy to be formed
Thrombus has good antithrombotic property, and the thickness of resistance blood layer is 10 microns -300 microns, wherein resistance blood layer thickness is micro- more than 10
Rice, it can be ensured that the courageous and upright energy of resistance, resistance blood layer thickness are less than 300 microns, ensure blood vessel only in the case where keeping basic performance
It is thick；Fine and close resistance blood layer porosity is 10%-80%, and hole can reduce the weight of tube wall, hinder the average pore size of the micropore of blood layer
It it is 0.1 micron -10 microns, smaller aperture can ensure that the resistance courage and uprightness energy of blood vessel, make in art and postoperative not oozing of blood；Micropore is deposited
Be conducive to adherency of the endothelial cell in tube chamber inner surface.
Elastomer layer is by porous silica gel, microvoid polyurethane（PU）, polyurethane（PU）One or more of nanofiber into
It is grouped as, different materials are respectively provided with good elasticity, and artificial blood vessel is made to have good compliance and mechanical performance, was being used
It is unlikely to deform in journey or kinking angulation, and the plugging effect after pin puncture is also fine.The thickness of elastomer layer is 20 micron -600
Micron, thickness are more than 20 microns, it can be ensured that the elasticity of blood vessel；Thickness is less than 600 microns, in the case where keeping basic performance
Ensure that blood vessel is not blocked up.The porosity of elastomer layer is 20%-90%, and hole can reduce the weight of tube wall, the average hole of micropore
Diameter is 0.5 micron -100 microns（When aperture is excessive, it is unfavorable for middle layer and keeps good elasticity；Average pore size for 0.5 micron-
100 microns are conducive to human body cell and grow into middle layer from tube wall outer layer three-dimensional or be adhered to outer layer and the intersection of middle layer）.
Fiber-reinforced layer be using PET fiber, silk, PU fibers, PP fibers, PE fibers, one kind in PTFE fiber or
Several ingredients pass through the tubing that is process including but not limited to textile technologies such as warp knit, weft knitting, tatting, braidings（Make
Blood vessel has good intensity）, the thickness of textile reinforcement is 40 microns -500 microns（Thickness is more than 40 microns, it can be ensured that
Blood vessel has enough intensity；Thickness is less than 500 microns, ensures that blood vessel is not blocked up in the case where keeping basic performance）, hole
Rate is 30%-70%（It is the basic performance of fabric）, the average pore size of micropore is 20 microns -200 microns（In this pore diameter range,
Cell and tissue fluid three-dimensional outside tube wall can penetrate into）.The internal diameter of artificial blood vessel is 3mm-46mm（Common artificial blood in human body
Pipe diameter）, pipe thickness is 200 microns -1400 microns（Thickness be more than 200 microns, it is ensured that the intensity of artificial blood vessel, make its
In vivo in use, will not be damaged due to compression, it avoids causing secondary injury to patient；Thickness is less than 1400 microns, is ensuring
Make vascular wall not blocked up in the case of basic performance, since artificial blood vessel is foreign matter in vivo, blocked up tube wall can make patient
It is unfavorable identical with people's body vessel into sense of discomfort, and blocked up tube wall can influence the compliance of blood vessel）, shape can be
Straight barrel type, variable diameters tubular type, tubular branch type and tubular branching type（Commonly used artificial blood vessel shape in human body）.People
Resistance courage and uprightness energy, the tissue of each layer of hematopoiesis pipe grow into performance, antithrombotic property, mechanical strength and thickness and change in gradient, wherein：
It can be in increase tendency from outer layer to internal layer to hinder courage and uprightness；It is in reduction trend from outer layer to internal layer that cell, which grows into performance,；Antithrombotic property,
It is in enhancing trend from outer layer to internal layer；Mechanical strength is in reduction trend from outer layer to internal layer；Thickness, outer layer is most thick, secondly in
Interbed, internal layer thickness are minimum.
Relative to the prior art, beneficial effects of the present invention are：
(1) as a result of technical scheme of the present invention, artificial blood vessel of the invention can effectively solve artificial blood vessel and use
The problems such as permeability resistance, antithrombotic, compliance, biocompatibility and mechanical performance in journey, suitable pore-size distribution makes carefully
Born of the same parents can realize that three-dimensional is grown into tube wall, promote artificial blood vessel prosthese integrated with surrounding tissue；The artificial blood of the present invention
Pipe can obtain extensively sending out application in vascular surgery field；
(2) this method is easy to operate, favorable repeatability, and high financial profit has a good application prospect.
Description of the drawings
Fig. 1 is the schematic cross-section of the artificial blood vessel of the present invention；
Fig. 2 is straight barrel type artificial blood vessel schematic diagram；
Fig. 3 is the schematic diagram of variable diameters tubular type artificial blood vessel；
Fig. 4 is the schematic diagram of three branching type artificial blood vessel of tubular.
Specific embodiment
With reference to specific embodiment, the present invention is furture elucidated.
According to Fig. 1, a kind of three-decker composite artificial blood vessel of the invention, by fine and close resistance blood layer 1, elastomer layer 2,
Fiber-reinforced layer 3 forms, wherein, fine and close resistance blood layer is in the inner surface of tube body, and elastomer layer is in the centre of tube body, fiber reinforcement
For layer in the outer surface of tube body, resistance blood layer, elastomer layer and fiber-reinforced layer are all distributed with micropore, and the size of micropore is from internal layer to outer
Layer is in whole increase tendency.
Embodiment 1
Please refer to Fig. 2, a kind of straight barrel type three-decker artificial blood vessel, the internal diameter of blood vessel is 5mm, length 45cm, pipe thickness
It is 487 microns.Pipe thickness refers to the overall thickness of fine and close resistance blood layer 1, elastomer layer 2, fiber-reinforced layer 3.
The thickness of each layer of pipe thickness and tube wall of artificial blood vessel is by calibrator in pressure 17.5kPa, Foot area
50mm2Under conditions of test：A point laterally is surveyed every 2cm, measures 5 points altogether, all measurement points are averaged.The hole of each layer
Gap rate is tested by the method that liquid replaces：By the use of ethyl alcohol as substitution liquid, material is put into known volume（V1）Ethyl alcohol it is molten
In liquid, after ten minutes, the mixed volume of ethyl alcohol and material is recorded（V2）, material from ethanol solution is removed, is recorded in graduated cylinder
Remaining volumes of aqueous ethanol（V3）, the porosity of material（ρ）It is calculated as follows：ρ(%) = (V1-V3)/(V2-V3).Pipe
The aperture of each layer of wall is measured using PMI apertometers, specially：Sample to be measured is cut into the circle of a diameter of 1.5cm or so；With
Fountain solution soak sample, after by sample be put into adaptation disk in；Sealing opens intake valve, gas is passed through in test box；With pressure
The increase of power, the maximum diameter of hole of sample（Or it is bubble point aperture）It is first opened, then less and less hole is opened, and tests boundary
Face shows a stem curve and a wet curve, and the half of each point value on stem curve is taken to make one and half stem curves,
Pressure value on the crosspoint of this half stem curve and corresponding wet curve can calculate average pore size.The internal layer of tube body is varicosity poly- four
Vinyl fluoride, thickness are 102 microns, and porosity 73%, average pore size is 0.5 micron；Middle layer is porous silica gel, thickness 179
Micron, porosity 61%, average pore size are 51 microns；Outer layer is the fabric that silk is processed by warp knit, and thickness is 206 microns,
Porosity is 52%, and average pore size is 150 microns.
The test of artificial blood vessel permeability performance：One end of artificial blood vessel is fixed on water creep appearance, other end metal clip
It is closed.The water valve of water creep appearance is opened, makes artificial blood vessel water-filling,（16.0±0.3）Under the hydraulic pressure of kPa, measure in 10min
The volume of the water oozed out from tube wall.The artificial blood vessel being prepared, infiltration is 0 under 16kPa.
Bend resistance experiment is carried out to the tube body of artificial blood vessel, when bending angle is 60 °, measurement obtains bending place tube chamber
Minimum diameter is 4.6mm, i.e., for artificial blood vessel in bending, the tube chamber of bending place has remained on good shape.
The compliance of intravascular stent under hygrometric state, test device main analog are measured with the vascular compliance test device of customization
Blood of human body flowing causes stress vascular wall and expands, the variation of record blood vessel internal diameter in diastole and contraction, so as to calculate
Go out the size of compliance.Calculation is as follows：%Compliance=[（RP2-RP1）/RP1]/(P2-P1)×104, wherein, R is people
The internal diameter of hematopoiesis pipe, RP1It is internal diameter of the pressure in 80mmHg, RP2It is internal diameter of the pressure in 120mmHg, P1=80mmHg, P2=
120mmHg.Show that the compliance of artificial blood vessel is 4.1% by measuring and calculation.
Embodiment 2
Fig. 3 is please referred to, a kind of variable diameters tubular type three-decker artificial blood vessel, the internal diameter of blood vessel is 4-7mm（Internal diameter in it is continuous gradually
Become）, length 45cm, pipe thickness is 577 microns.Thickness, porosity and the opening size test method reference implementation of each layer of tube body
Example 1.Its internal layer is PU layers of nanofibers, and thickness is 116 microns, and porosity 75%, average pore size is 0.8 micron；Middle layer is
Microvoid polyurethane layer, thickness are 252 microns, and porosity 70%, average pore size is 26 microns；Outer layer is polytetrafluoroethylene fibre
Knitted fabric, thickness are 209 microns, and porosity 45%, average pore size is 154 microns.Reference implementation example 1, to artificial blood vessel
Permeability performance is tested, and it is 0 that water percolating capacity is measured under 16kPa.Bending experiment is carried out to the tube body of artificial blood vessel, with diameter
Centered on the tube body at 5.5mm, when bending angle is 60 °, the minimum diameter that measurement obtains bending place tube chamber is 4.9mm,
I.e. for artificial blood vessel in bending, the tube chamber of bending place has remained on good shape.The method of reference implementation example 1 measures artificial
The compliance of blood vessel is 3.3%.
Embodiment 3
Please refer to Fig. 4, a kind of three branching type three-decker artificial blood vessel of tubular, inner major diameter 20mm, length 40cm, tube wall
Thickness is 535 microns.Thickness, porosity and the opening size test method of each layer of main body and branch are with reference to embodiment 1.The internal layer of main body
For PU layers of nanofibers, thickness is 147 microns, and porosity 78%, average pore size is 1.1 microns；Middle layer is porous silica gel,
Thickness is 173 microns, porosity 63%, and average pore size is 53 microns；Outer layer is the fabric that PET fiber is processed by warp knit, thick
It is 215 microns to spend, porosity 48%, and average pore size is 164 microns.The internal diameter of branch be 8mm, length 15cm, pipe thickness
It is 443 microns.The internal layer of branch is PU layers of nanofibers, and thickness is 101 microns, porosity 78%, and average pore size is micro- for 1.1
Rice；Middle layer is porous silica gel, and thickness is 128 microns, and porosity 62%, average pore size is 51 microns；Outer layer is PET fiber
The fabric processed by warp knit, thickness are 214 microns, and porosity 48%, average pore size is 162 microns.To main body and branch
Permeability performance test is with reference to embodiment 1, and the water percolating capacity of main body and branch is 0 under 16kPa.To the master of three branch artificial blood vessels
Body has carried out bend resistance performance test, and when bending angle is 60 °, the minimum diameter that measurement obtains bending place tube chamber is
17.6mm, the tube chamber of bending place have remained on good shape.With reference to embodiment 1, main body to branching type artificial blood vessel and
Branch has carried out compliance test respectively, and the compliance of main body is 5.6%, branch 6.2%.
It should be understood that these embodiments are only illustrative of the invention and is not intended to limit the scope of the invention.In addition, it should also be understood that,
After reading the content taught by the present invention, those skilled in the art can make various modifications or changes to the present invention, these
Equivalent form is also fallen within the scope of the appended claims of the present application.
Claims (10)
1. a kind of three-decker composite artificial blood vessel, it is characterised in that：Artificial blood vessel is by fine and close resistance blood layer（1）, elastomer
Layer（2）And fiber-reinforced layer（3）Composition, wherein, fine and close resistance blood layer（1）In the inner surface of tube body, elastomer layer（2）In tube body
Centre, fiber-reinforced layer（3）In the outer surface of tube body, blood layer is hindered（1）, elastomer layer（2）And fiber-reinforced layer（3）All it is distributed
There is micropore（4）, micropore（4）Size from the internal layer of tube body to outer layer in gradual increased trend.
2. a kind of three-decker composite artificial blood vessel according to claim 1, it is characterised in that：Fine and close resistance blood layer
（1）By expanded PTFE（ePTFE）, polytetrafluoroethylene (PTFE)（PTFE）Nanofiber, polyurethane（PU）One in nanofiber
Kind or it is several into being grouped as；Fine and close resistance blood layer（1）Thickness is 10 microns -300 microns；Fine and close resistance blood layer（1）Porosity
For 10%-80%；Fine and close resistance blood layer（1）Micropore（4）Average pore size is 0.1 micron -10 microns.
3. a kind of three-decker composite artificial blood vessel according to claim 1, it is characterised in that：Elastomer layer（2）By
Porous silica gel, microvoid polyurethane（PU）, polyurethane（PU）One or more of nanofiber is into being grouped as；Elastomer layer（2）
Thickness is 20 microns -600 microns；Elastomer layer（2）Porosity be 20%-90%；Elastomer layer（2）Micropore（4）Average hole
Diameter is 0.5 micron -100 microns.
4. a kind of three-decker composite artificial blood vessel according to claim 1, it is characterised in that：Fiber-reinforced layer（3）
It is using polyethylene terephthalate（PET）Fiber, silk, polyurethane（PU）Fiber, polypropylene（PP）Fiber, polyethylene
（PE）Fiber, polytetrafluoroethylene (PTFE)（PTFE）One or more of fiber ingredient passes through including but not limited to warp knit, weft knitting, shuttle
The tubing that the textile technology knit, woven is process；Fiber-reinforced layer（3）Thickness is 40-500 microns；Fiber-reinforced layer
（3）Porosity be 30%-70%；Fiber-reinforced layer（3）Micropore（4）Average pore size is 20-200 microns.
5. a kind of three-decker composite artificial blood vessel according to claim 1, it is characterised in that：The internal diameter of artificial blood vessel
For 3mm-46mm；The pipe thickness of artificial blood vessel is 200-1400 microns.
6. a kind of three-decker composite artificial blood vessel according to claim 1, it is characterised in that：Artificial blood vessel is straight tube
Type, variable diameters tubular type, tubular branch type or tubular branching type.
7. a kind of three-decker composite artificial blood vessel according to claim 1, it is characterised in that：Artificial blood vessel is complied with
Property is 2%-9%.
8. a kind of three-decker composite artificial blood vessel according to claim 1, it is characterised in that：The resistance blood of artificial blood vessel
Performance is in increase tendency from outer layer to internal layer.
9. a kind of three-decker composite artificial blood vessel according to claim 1, it is characterised in that：The cell of artificial blood vessel
It is in reduction trend from outer layer to internal layer to grow into performance.
10. a kind of three-decker composite artificial blood vessel according to claim 1, it is characterised in that：Artificial blood vessel resists
Thrombus performance is in enhancing trend from outer layer to internal layer.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110063816A (en) * | 2019-04-28 | 2019-07-30 | 吉林大学中日联谊医院 | A kind of artificial blood vessel and its manufacturing method |
| CN110859998A (en) * | 2019-12-18 | 2020-03-06 | 上海畅迪医疗科技有限公司 | Anti-kink artificial blood vessel and preparation method thereof |
| CN110960281A (en) * | 2019-11-29 | 2020-04-07 | 上海畅迪医疗科技有限公司 | Blood vessel sling in operation with skin-core structure |
| CN111000660A (en) * | 2020-02-14 | 2020-04-14 | 上海畅迪医疗科技有限公司 | 3D printing artificial blood vessel and preparation method thereof |
| CN113397760A (en) * | 2021-05-27 | 2021-09-17 | 华中科技大学同济医学院附属协和医院 | Artificial blood vessel for aortic dissection surgery and preparation method thereof |
| CN113476661A (en) * | 2021-07-05 | 2021-10-08 | 中国医学科学院生物医学工程研究所 | Composite self-healing artificial blood vessel with three-layer structure and preparation method thereof |
| CN115192768A (en) * | 2022-06-14 | 2022-10-18 | 山东大学齐鲁医院 | Composite material artificial blood vessel and manufacturing process thereof |
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