CN104689367B - Absorbable skin suturing nail and preparation method thereof - Google Patents
Absorbable skin suturing nail and preparation method thereof Download PDFInfo
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- CN104689367B CN104689367B CN201510117194.8A CN201510117194A CN104689367B CN 104689367 B CN104689367 B CN 104689367B CN 201510117194 A CN201510117194 A CN 201510117194A CN 104689367 B CN104689367 B CN 104689367B
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Abstract
The invention provides an absorbable skin suturing nail and a preparation method thereof. The absorbable skin suturing nail comprises an inner body and an outer coating which are both manufactured from degradable materials, wherein the degrading speed of the material of the outer coating is less than that of the material of the inner body. According to the absorbable skin suturing nail comprising the inner body and the outer coating, the inner layer is mainly used for achieving mechanical property, and the outer coating is mainly used for insulating; the degrading speed of the outer coating is less than that of the inner body, so that the degrading time of the whole absorbable skin suturing nail can be prolonged, and as a result, the degrading rate of the whole absorbable skin suturing nail is reduced, the mechanical property can be maintained well for some time.
Description
Technical field
The present invention relates to medical instruments field, particularly relate to a kind of absorbable skin closure nail and preparation method thereof.
Background technology
Skin closure is the type of surgery on basis in surgical operation, and Skin sewing needle is conventional in surgical operation
Medical apparatus and instruments, operation principle is essentially identical with the principle of stapler, in the operation process propelling movement by stiching instrument,
Suturing nail in nail bin is pushed out, and thrusts skin incision both sides epidermis or internal layer, it is achieved skin closure.
The mode of skin closure has epidermis to sew up, and also has subcuticular suture.Skin closure nail also has two types, can not
Absorbing skin closure nail and can absorb skin closure nail, nonabsorable skin closure nail is metal, at present can only
Sew up for epidermis；Absorbable skin closure nail can be not only used for subcuticular suture and can also be used for epidermis stitching.
The absorbable skin closure nail used clinically at present is mainly used in subcuticular suture, this nail main body shape
Shape such as English alphabet " U ", at two ends with inside barb, in case suturing nail comes off in skin, nail
Size moderate, to meet the characteristic of skin closure.In sewing process, this staple is sewn dress
Put and be pushed to below skin according to certain rule, and fixing wound；In wound healing process, this inhale
Receive skin closure nail progressively to degrade, but preferable mechanical strength can be kept to fix wound；Substantially heal Deng wound
After, the mechanical strength of this absorbable skin closure nail just drops to sufficiently small, and nail itself produces and collapses
Solve, and gradually absorbed by human body.
Fig. 1 is the overall dimensions of clinical conventional absorbable skin closure nail.Conventional absorbable skin closure
The thickness of nail is generally 0.7～1.0mm, and length is about 4～6mm, and width is about 3～4mm.
According to the approval data of U.S. FDA, the initial tensile strength of absorbable skin closure nail is not less than 6.7
Newton；In at 37 DEG C, containing salt buffer after one day, tensile strength is not less than 3.4 newton；And 37 DEG C,
Containing in salt buffer 7 days, the tensile strength of residual was not less than 1.7 newton.
Usually, the healing of post-operative wound needs two time-of-weeks, three time-of-weeks to heal completely,
First healing stage is in 0-7 days, and wound also keeps relatively hightension, now can absorb the tensile strength of skin closure nail
Should be higher；Along with the progressively healing of wound, the tension force of wound self can progressively reduce, and now can absorb skin
The tensile strength of skin suturing nail can appropriateness decline；After general to two weeks, wound heals substantially, it may be unnecessary to
Suturing nail plays fixing suturing, and after three weeks, wound heals completely, and now caning absorb skin closure nail should be
Timely disintegrate in several days, and absorbed by human body.
Summary of the invention
The technical problem that present invention mainly solves is to provide a kind of new absorbable skin closure nail and preparation system thereof
Preparing for method, mechanical characteristic and the degradation characteristic of this absorbable skin closure nail can better conform to wound healing
Rule, its initial tensile strength is not less than 6.7 newton；Wound suture second day, absorbable skin seam
The tensile strength of dowel is not less than 4.7 newton；At the 7th day, the tensile strength of absorbable skin closure nail was the lowest
In 3.4 newton；At the 14th day, residual tensile strength was not less than 1.7 newton；And 21-30 after it has been gathered
My god, absorbable skin closure nail disintegrate；Afterwards, the material of absorbable skin closure nail is gradually inhaled by human body
Contracture solution.
For solving above-mentioned technical problem, the present invention uses the absorbable skin closure of band coating to follow closely；
A kind of absorbable skin closure nail, including interior layer main body and outer coating；
The material of described interior layer main body and the material of described outer coating are degradation material；
The degradation speed of the material of wherein said outer coating is less than the degraded speed of the material of described interior layer main body
Degree；
The blend that material is PLGA and PDLGA of wherein said interior layer main body, in described blend
The mass fraction ratio of PLGA with PDLGA is 99～80:1～20；
In wherein said PLGA, L-lactide is 55～70:45:30 with the mol ratio of Acetic acid, hydroxy-, bimol. cyclic ester, wherein said
DL-lactide and the mol ratio 55～70:45～30 of Acetic acid, hydroxy-, bimol. cyclic ester in PDLGA.
The material of described outer coating is PLLA or the blend for PLLA and PDLA；Described PLLA
It is 70～99:30～1 with the mass fraction ratio of PLLA and PDLA in the blend of PDLA.
Wherein in an embodiment, the viscosity of the PLGA of described internal layer material of main part is 1.8～3.0dl/g,
The dispersion of molecular weight is 1.4～1.7；
The viscosity of described PDLGA is 2.0～2.5dl/g, and the dispersion of molecular weight is 1.4～1.7；
Monomer residue molar content in described PLGA and described PDLGA is no more than 1%；
Water content in described PLGA and described PDLGA is respectively less than 500ppm.
Wherein in an embodiment, the intrinsic viscosity of described outer coating material PLLA or PDLA is
2.0-4.0dl/g, molecular weight dispersity 1.4-1.7；
Water content in described PLLA and described PDLA is respectively less than 500ppm.
Wherein in an embodiment, the thickness of described outer coating is 10 microns to 100 microns.
Wherein in an embodiment, described outer coating is coated uniformly on the surface of described interior layer main body.
The preparation method of above-mentioned absorbable skin closure nail, comprises the steps:
S100: layer main body in preparation；
S200: use the method for dipping or spraying to prepare outer coating on described interior layer main body；
S300: described outer coating is dried process.
Wherein in an embodiment, step S200 and step S300 are repeated several times and carry out.
Wherein in an embodiment, the thickness of the outer coating of dipping or coating is less than 10 microns every time.
Wherein in an embodiment, described dried is carried out in vacuum or nitrogen or noble gas.
Wherein in an embodiment, described step S200 also includes dissolved by outer coating material being coated with
Cover solution, then use described coating solution to carry out the step impregnating or spraying, in wherein said coating solution
The mass percent of outer coating material is not more than 5%.
The invention has the beneficial effects as follows: the absorbable skin closure nail of the present invention includes that interior layer main body and outer layer are coated with
Layer, wherein internal layer mainly realizes mechanical characteristic, and outer coating primarily serves insulating effect；Due to outer coating
Degradation speed is significantly less than the degradation speed of interior layer main body, therefore, it is possible to extend whole absorbable skin closure nail
Degradation time so that whole absorbable skin closure nail degradation rate the most slack-off, mechanical property
Keep is relatively good；The when that outer layer being degraded to a certain degree, owing to moisture starts to penetrate into internal layer, internal layer meeting
Start degraded, but due to the protective effect of outer layer so that the degradation speed ratio of absorbable skin closure nail is simple
The nail speed that body is made can be slow, especially at the wound healing initial stage, can preferably retain suturing nail
Preferably mechanical strength.Protective coating can not be blocked up, and blocked up meeting appreciable impact can absorb skin closure nail
Overall dimensions.
Accompanying drawing explanation
Fig. 1 is the overall schematic of currently used absorbable skin closure nail；
Fig. 2 is the schematic cross-section of an embodiment of the absorbable skin closure nail of the present invention；
Fig. 3 is the schematic cross-section of the other direction of an embodiment of the absorbable skin closure nail of the present invention；
Fig. 4 a-Fig. 4 d is the degradation experiment figure of the absorbable skin closure nail of embodiment one；
Fig. 5 a-Fig. 5 d is the degradation experiment figure of the absorbable skin closure nail of comparative example；
Fig. 6 is the tensile strength curve of the absorbable skin closure nail of embodiment one and comparative example.
Detailed description of the invention
Purpose, technical scheme and advantage for the absorbable skin closure nail making the present invention and preparation method thereof
Clearer, below in conjunction with concrete drawings and the specific embodiments, the present invention is carried out the most specifically
Bright.
It should be noted that in the case of not conflicting, the embodiment in the application and the feature in embodiment
Can be mutually combined.
So that skin closure nail can meet degradation characteristic requirement as far as possible, see Fig. 2 and Fig. 3, this
Invention provides one absorbable skin closure nail, including interior layer main body 100 and outer coating 200；Described internal layer
The material of main body 100 and the material of described outer coating 200 are degradation material；Wherein said outer layer is coated with
The degradation speed of the material of layer 200 is less than the degradation speed of the material of described interior layer main body 100.Preferably,
At 37 DEG C, in the phosphate buffer of pH=7.3-7.5, the degradation speed of outer coating 200 is 3-7 days,
The time being degraded to initial tensile strength 50% of interior layer main body 100 is 5-10 days.
The material of wherein said interior layer main body be the PLGA random copolymer of Acetic acid, hydroxy-, bimol. cyclic ester (the L-lactide with) with
The blend of PDLGA (DL-lactide and the random copolymer of Acetic acid, hydroxy-, bimol. cyclic ester), the matter of PLGA Yu PDLGA
Amount portion rate is 99～80:1～20.The present invention can absorb skin closure nail the used PLGA of internal layer body and
The blend of PDLGA；PLGA is L-PLGA, at PLGA used in the present invention
Middle L-lactide is 55～70:45～30 with the mol ratio of Acetic acid, hydroxy-, bimol. cyclic ester, i.e. the molar content of L-lactide is
55%～70%, the molar content 45%～30% of Acetic acid, hydroxy-, bimol. cyclic ester；PDLGA of the present invention is that DL-third hands over
Ester and the random copolymer of Acetic acid, hydroxy-, bimol. cyclic ester, wherein DL-lactide and the mol ratio of Acetic acid, hydroxy-, bimol. cyclic ester in PDLGA
The molar content of 55～70:45～30, i.e. DL-lactide is 55%～70%, and the Mole percent of Acetic acid, hydroxy-, bimol. cyclic ester contains
Amount is 45%～30%.
PLGA (L-lactide and the random copolymer of Acetic acid, hydroxy-, bimol. cyclic ester) and PDLGA (DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester
Random copolymer) there is good biodegradability and biocompatibility, vitrification point is more than 40 DEG C,
The most often by as medical material, obtain extensively application clinically；Merely, PLGA or PDLGA is selected
For the material followed closely as absorbable skin closure, the mechanical property of its goods and degradation characteristic tend not to same
Time meet requirement.The absorbable skin closure nail that the intermingling material of PLGA or PLGA and PDLGA makes is logical
Overregulate the blended proportioning of properties of materials viscosity or material, initial tensile strength requirement can be met, but
Degradation time often ratio is comparatively fast；And if using PLGA (its of the slow high L-lactide proportioning of degradation time
The molar content of middle L lactide is 100%～80%), degradation time can be greatly prolonged, but material is more crisp, prolong
Stretching property is poor, and mechanical property cannot be up to standard.
Meanwhile, the intrinsic viscosity of the PLGA used is 1.8～3.0dl/g, and the dispersion of molecular weight is
1.4～1.7, the intrinsic viscosity of more excellent PLGA is 2.1～2.3dl/g.The intrinsic viscosity of the PDLGA used
Being 2.0～2.5dl/g, the dispersion of molecular weight is 1.4～1.7, and the intrinsic viscosity of more excellent PDLGA is
2.1-2.3dl/g。
More excellent, the intrinsic viscosity of PLGA and PDLGA in interior layer main body should be equal.
It should be noted that, the monomer residue molar content in PLGA in the present invention should be not more than
Monomer residue molar content in 1%, and PDLGA is also not more than 1%；Water in PLGA and PDLGA
Divide percentage composition all should be less than 500ppm.
The outer layer coating outer coating of the internal layer body of absorbable skin closure nail, the outer layer in the present embodiment is coated with
Layer is another kind of degradation material, and the degradation speed of outer coating material is significantly slower than the fall of internal layer bulk material
Solve speed.The material of the present embodiment ectomesoderm coating is PLLA (PLLA) or PLLA Yu PDLA (DL-
Polylactic acid) blend.PLLA with PDLA is the same with the material of interior layer main body, has good bio-compatible
Property, and decomposition can be absorbed by human body.When the blend that outer coating is PLLA and PDLA, blend
The mass fraction ratio of middle PLLA with PDLA is 99～80:1～20.
Wherein the intrinsic viscosity of PLLA Yu PDLA is 2.0～4.0dl/g (preferably, PLLA and PDLA
Intrinsic viscosity be 2.0～3.0dl/g), molecular weight dispersity 1.4～1.7.When outer coating is PLLA and PDLA
Blend time, the intrinsic viscosity of PLLA with PDLA should be the most equal or close, so to material
Mechanical characteristic is easier to control.
Meanwhile, the respective water content of material PLLA and PDLA of described outer coating is respectively less than 500ppm.
Preferably, as a kind of embodiment, the thickness of described outer coating 200 be 10 microns to 100
Micron.
Preferably, as a kind of embodiment, described outer coating 200 is coated uniformly on described internal layer master
The surface of body 100.
Present invention simultaneously provides the preparation method of a kind of absorbable skin closure nail, comprise the following steps:
S100: layer main body in preparation；The preparation method of interior layer main body includes being total to PLGA and PDLGA
Mixed material is raw material, is prepared by the technique of injection.Its preparation process is first by PLGA and PDLGA
Raw material mixes according to a certain percentage, and is heated to certain temperature and melts and become molten condition, then
It is molded under pressure, uses the way of mold injection to form interior layer main body.In injection moulding process, protect
Holding that intermingling material is melted and injection temperature is 150-180 DEG C, injection keeps pressure to be 50-80bar.Injection moulding process
In, raw material should be further dried at exsiccator, and prevents moisture in air from invading；And feed at injection machine
And raw-material melting process all has nitrogen to protect；When mould is cooled directly with water below 40 DEG C, the demoulding takes
The most i.e. can obtain the interior layer main body of absorbable skin closure nail, and sizing in 24 hours in the dry state.
S200: use the method for dipping or spraying to prepare outer coating on described interior layer main body.Internal layer master
After prepared by body, the outer layer at interior layer main body is coated.Concrete operation step is to choose PLLA material
Or being blended as coating material of the material of PLLA (PLLA) and PDLA (DL-polylactic acid)；
Choose chloroform or other readily soluble organic solvents, coating material is dissolved in a solvent.Coating mainly has
Dip-coating method or spraying process, dip-coating method is placed in solution then lifting nail body exactly and comes up,
And spraying process be exactly solution mist chemical conversion fine particle be uniformly sprayed at nail body surface.Dip-coating method is optional
Taking any solution of somewhat thickness, in coating solution, the mass percent of solute is 3～5%；And spraying process uses
Coating in the mass percent of solute should be less than or equal to 1%.Infusion process is coated, each Best-Effort request
Should be dried rapidly the most afterwards,；For spraying process, it would however also be possible to employ spraying once, is dried way once.Many
Secondary dipping or the thickness of spray painting control coating.The thickness of outer coating is 10～100 microns.
S300: described outer coating is dried process.
Carry out it is also preferred that the left step S200 and step S300 are repeated several times.It is thicker for coating thickness requirement,
Take repeatedly the way of Best-Effort request or spraying.Typically, for thicker coating, can carry out many
Secondary coating, coating uniformly should be unlikely to the thickest first, and is dried rapidly, in order to avoid solvent dissolves body and leads
Cause body distortion.
Wherein, the thickness of the outer coating of single impregnation or spraying is less than 10 microns, is dried the most rapidly, keeps away
Exempt from the solvent dissolving to internal layer material.Best-Effort request painting method, single coating layer thickness will not be the thickest, typically
For less than 10 microns, can take repeatedly to be dried, the method repeatedly impregnated；And spraying process to ensure spraying
Solution thickness is suitable, spraying all with, speed is moderate.The thickness of the outer coating impregnated first or spray
Degree definitely should be less than 10 microns.
The way mainly boulton process being dried described in above-mentioned steps or seasoning of bleeding, if wanted
Heat, it is necessary to control in scope safe below vitrification point.After coating terminates, should utilize in time
Vacuum drying removes residual solvent and moisture.
Wherein, described step S200 also includes dissolving outer coating material obtaining outer coating solution, so
Rear employing outer coating solution carries out the step impregnating or spraying.Wherein the preparation of the coating of outer coating is to adopt
Being dissolved by outer coating material with organic solvent, organic solvent is chloroform, when using infusion process when,
In coating solution, the mass percent of solute (i.e. outer coating material) should be less than 5%；Should the when of spraying process
Make adjustment according to equipment comparative example, but in coating solution, the mass percent of solute is usually no more than 1%.
It should be noted that raw material and equipment employed in following example are commercially available.
Embodiment one
The blend that interior layer main body is PLGA and PDLGA of the absorbable skin closure nail in the present embodiment,
Wherein the mass fraction of PLGA and PDLGA is than for 80:20.L-in the PLGA used in the present embodiment
The molar content of lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than for 70:30, DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in the PDLGA of employing
Molar content than for 70:30.Wherein the intrinsic viscosity of PLGA is 1.8dl/g, and the dispersion of molecular weight is
1.4；The intrinsic viscosity of PDLGA is 2.0dl/g, and the dispersion of molecular weight is 1.4.
The material of the outer coating in the present embodiment is PLLA and PDLA blend, wherein PLLA and
The mass fraction of PDLA is than for 80:20.The thickness of outer coating is 20 microns.Wherein the characteristic of PLLA is glued
Degree is 2.0dl/g, and the dispersion of molecular weight is 1.4；The intrinsic viscosity of PDLA is 4.0dl/g, molecular weight
Dispersion is 1.4.
In the present embodiment, the thickness of absorbable skin closure nail is 0.8mm.
Comparative example
Absorbable skin closure nail in comparative example only comprises interior layer main body, and its internal layer material of main part is PLGA
(70:30) with the blend of PDLGA (70:30), the mass fraction of PLGA and PDLGA ratio is for 80:20.
The thickness of the absorbable skin closure nail in comparative example is 0.8mm.
The absorbable skin closure of embodiment one is followed closely and the absorbable skin closure nail of comparative example all uses dosage
Radiated by gamma-ray for 25KGY carries out sterilization treatment.Then the absorbable skin closure of the present invention is followed closely and
The absorbable skin closure nail of comparative example is all separately positioned at 37 DEG C, in the phosphate buffer of pH=7.3～7.5
Do degradation experiment.
Wherein Fig. 4 a-Fig. 4 d be embodiment one absorbable skin closure nail degraded picture, wherein Fig. 4 a is
The absorbable skin closure nail degraded photo of 1 day of embodiment one, Fig. 4 b is the absorbable skin of embodiment one
The photo that suturing nail is degraded 7 days, Fig. 4 c is the absorbable skin closure nail degraded photograph of 14 days of embodiment one
Sheet, Fig. 4 d is the absorbable skin closure nail degraded photo of 21 days of embodiment one.
Fig. 5 a-Fig. 5 d is the degraded picture of the absorbable skin closure nail of comparative example, and wherein Fig. 5 a is comparative example
The absorbable skin closure nail degraded photo of 1 day, Fig. 5 b is the absorbable skin closure nail degraded of comparative example
The photo of 7 days, Fig. 5 c is the absorbable skin closure nail degraded photo of 14 days of comparative example, and Fig. 5 d is right
The absorbable skin closure nail degraded photo of 21 days of ratio.
The muddy degree of absorbable skin closure nail itself can show moisture and penetrate into the degree of this suturing nail.
Contrasted it is found that the ratio of band coating is not coated piece of by the picture of Fig. 4 a-Fig. 4 d and Fig. 5 a-Fig. 5 d
More difficult invaded by moisture.
Test for tensile strength data and curve see Fig. 6.See Fig. 6, caning absorb of embodiments of the invention one
The experimental result of skin closure nail is as follows: initial tensile strength 7.8 newton；After degrading 1 day, tensile strength
6.3 newton；After 7 days, tensile strength 4 newton；After 14 days, tensile strength 1.8 newton；After 21 days, anti-
Tensile strength 0.5 newton, within 25 days, there is disintegrate in suturing nail, meets requirement.
Seeing Fig. 6, the tensile strength experimental result of the absorbable skin closure nail of comparative example is as follows: initial tensile
Intensity 7.6 newton；After degrading one day, tensile strength 5.5 newton, after degrading 7 days, tensile strength 2.7 Ns
?；After 14 days, tensile strength 1.2 newton, after 21 days, disintegrate.Therefore it is obvious that embodiment
The tensile strength of the absorbable skin closure nail of is strong apparently higher than the tension of comparative example in each stage of experiment
The not coated piece of absorbable skin closure nail of degree, i.e. comparative example loses speed at degradation speed and tensile strength
On be above embodiment one band coating absorbable skin closure nail.
Embodiment two
The blend that interior layer main body is PLGA and PDLGA of the absorbable skin closure nail in the present embodiment,
Wherein the mass fraction of PLGA and PDLGA is than for 99:1.L-third in the PLGA used in the present embodiment
The molar content of lactide and Acetic acid, hydroxy-, bimol. cyclic ester than for 70:30, DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in the PDLGA of employing
Molar content is than for 70:30.Wherein the intrinsic viscosity of PLGA is 2.1dl/g, and the dispersion of molecular weight is 1.5；
The intrinsic viscosity of PDLGA is 2.1dl/g, and the dispersion of molecular weight is 1.6.
The material of the outer coating in the present embodiment is PLLA and PDLA blend, wherein PLLA and
The mass fraction of PDLA is than for 99:1.The thickness of the present embodiment ectomesoderm coating is 10 microns.PLLA's
Intrinsic viscosity is 2.5dl/g, and the dispersion of molecular weight is 1.5；The intrinsic viscosity of PDLA is 2.5dl/g, point
The dispersion of son amount is 1.6.
Embodiment three
The blend that interior layer main body is PLGA and PDLGA of the absorbable skin closure nail in the present embodiment,
Wherein the mass fraction of PLGA and PDLGA is than for 90:10.L-in the PLGA used in the present embodiment
The molar content of lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than for 70:30, DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in the PDLGA of employing
Molar content than for 70:30.Wherein the intrinsic viscosity of PLGA is 2.3dl/g, and the dispersion of molecular weight is
1.6；The intrinsic viscosity of PDLGA is 2.3dl/g, and the dispersion of molecular weight is 1.6.
The material of the outer coating in the present embodiment is PLLA and PDLA blend, wherein PLLA and
The mass fraction of PDLA is than for 80:20.The thickness of outer coating is 30 microns.The intrinsic viscosity of PLLA is
3.0dl/g, the dispersion of molecular weight is 1.6；The intrinsic viscosity of PDLA is 3.5dl/g, the dispersion of molecular weight
It is 1.7.
Embodiment four
The blend that interior layer main body is PLGA and PDLGA of the absorbable skin closure nail in the present embodiment,
Wherein the mass fraction of PLGA and PDLGA is than for 85:15.L-in the PLGA used in the present embodiment
The molar content of lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than for 55:45, DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in the PDLGA of employing
Molar content than for 70:30.Wherein the intrinsic viscosity of PLGA is 2.6dl/g, and the dispersion of molecular weight is
1.7；The intrinsic viscosity of PDLGA is 2.5dl/g, and the dispersion of molecular weight is 1.7.Outer layer in the present embodiment
The material of coating is PLLA and PDLA blend, and wherein the mass fraction ratio of PLLA and PDLA is
90:10.The thickness of outer coating is 60 microns.The intrinsic viscosity of PLLA is 4.0dl/g, the dispersion of molecular weight
Degree is 1.7；The intrinsic viscosity of PDLA is 4.0dl/g, and the dispersion of molecular weight is 1.7.
Embodiment five
The blend that interior layer main body is PLGA and PDLGA of the absorbable skin closure nail in the present embodiment,
Wherein the mass fraction of PLGA and PDLGA is than for 95:5.L-third in the PLGA used in the present embodiment
The molar content of lactide and Acetic acid, hydroxy-, bimol. cyclic ester than for 60:40, DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in the PDLGA of employing
Molar content is than for 70:30.Wherein the intrinsic viscosity of PLGA is 3.0dl/g, and the dispersion of molecular weight is 1.7；
The intrinsic viscosity of PDLGA is 2.5dl/g, and the dispersion of molecular weight is 1.7.
The material of the outer coating in the present embodiment is PLLA.The thickness of outer coating is 80 microns.PLLA
Intrinsic viscosity be 4.0dl/g, the dispersion of molecular weight is 1.7；The intrinsic viscosity of PDLA is 4.0dl/g,
The dispersion of molecular weight is 1.7.
Embodiment six
The blend that interior layer main body is PLGA and PDLGA of the absorbable skin closure nail in the present embodiment,
Wherein the mass fraction of PLGA and PDLGA is than for 90:10.L-in the PLGA used in the present embodiment
The molar content of lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than for 70:30, DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in the PDLGA of employing
Molar content than for 55:45.Wherein the intrinsic viscosity of PLGA is 3.0dl/g, and the dispersion of molecular weight is
1.7；The intrinsic viscosity of PDLGA is 2.5dl/g, and the dispersion of molecular weight is 1.7.
The material of the outer coating in the present embodiment is PLLA.The thickness of outer coating is 90 microns.PLLA
Intrinsic viscosity be 4.0dl/g, the dispersion of molecular weight is 1.7；The intrinsic viscosity of PDLA is 4.0dl/g,
The dispersion of molecular weight is 1.7.
Embodiment seven
The blend that interior layer main body is PLGA and PDLGA of the absorbable skin closure nail in the present embodiment,
Wherein the mass fraction of PLGA and PDLGA is than for 90:10.L-in the PLGA used in the present embodiment
The molar content of lactide and Acetic acid, hydroxy-, bimol. cyclic ester is than for 70:30, DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in the PDLGA of employing
Molar content than for 60:40.Wherein the intrinsic viscosity of PLGA is 3.0dl/g, and the dispersion of molecular weight is
1.7；The intrinsic viscosity of PDLGA is 2.5dl/g, and the dispersion of molecular weight is 1.7.
The material of the outer coating in the present embodiment is PLLA and PDLA blend, wherein PLLA and
The mass fraction of PDLA is than for 70:30.The thickness of outer coating is 100 microns.The intrinsic viscosity of PLLA
For 4.0dl/g, the dispersion of molecular weight is 1.7；The intrinsic viscosity of PDLA is 4.0dl/g, dividing of molecular weight
Divergence is 1.7.
Embodiment described above only have expressed the several embodiments of the present invention, and it describes more concrete and detailed,
But therefore can not be interpreted as the restriction to the scope of the claims of the present invention.It should be pointed out that, for this area
Those of ordinary skill for, without departing from the inventive concept of the premise, it is also possible to make some deformation and
Improving, these broadly fall into protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be with right
Requirement is as the criterion.
Claims (10)
1. an absorbable skin closure nail, it is characterised in that include interior layer main body and outer coating；
The material of described interior layer main body and the material of described outer coating are degradation material；
The degradation speed of the material of wherein said outer coating is less than the degraded speed of the material of described interior layer main body
Degree；
The blend that material is PLGA and PDLGA of wherein said interior layer main body, in described blend
The mass fraction ratio of PLGA with PDLGA is 99～80:1～20；In wherein said PLGA L-lactide with
The mol ratio of Acetic acid, hydroxy-, bimol. cyclic ester is 55～70:45～30, DL-lactide and Acetic acid, hydroxy-, bimol. cyclic ester in wherein said PDLGA
Mol ratio 55～70:45～30；
Wherein said PLGA is the random copolymer of L-lactide and Acetic acid, hydroxy-, bimol. cyclic ester, and described PDLGA is DL-
Lactide and the random copolymer of Acetic acid, hydroxy-, bimol. cyclic ester；
The material of described outer coating is PLLA or the blend for PLLA and PDLA；Described PLLA
It is 70～99:30～1 with the mass fraction ratio of PLLA and PDLA in the blend of PDLA.
Absorbable skin closure the most according to claim 1 is followed closely, it is characterised in that described interior layer main body
Material in, the intrinsic viscosity of described PLGA is 1.8～3.0dl/g, and the dispersion of molecular weight is 1.4-1.7；
The intrinsic viscosity of described PDLGA is 2.0～2.5dl/g, and the dispersion of molecular weight is 1.4-1.7；
The molar content of the monomer residue in described PLGA and described PDLGA is no more than 1%；
Water content in described PLGA and described PDLGA is respectively less than 500ppm.
Absorbable skin closure the most according to claim 1 is followed closely, it is characterised in that described outer coating
Material in, the intrinsic viscosity of described PLLA or described PDLA is 2.0-4.0dl/g, and molecular weight dispersity is
1.4-1.7；
Water content in described PLLA and described PDLA is respectively less than 500ppm.
Absorbable skin closure the most according to claim 1 is followed closely, it is characterised in that described outer coating
Thickness be 10 microns to 100 microns.
Absorbable skin closure the most according to claim 1 is followed closely, it is characterised in that described outer coating
It is coated uniformly on the surface of described interior layer main body.
6. the preparation method of the absorbable skin closure nail described in claim 1 to 5 any one, its feature
It is, comprises the steps:
S100: layer main body in preparation；
S200: use the method for dipping or spraying to prepare outer coating on described interior layer main body；
S300: described outer coating is dried process.
Preparation method the most according to claim 6, it is characterised in that step S200 and step S300
It is repeated several times and carries out.
Preparation method the most according to claim 7, it is characterised in that dipping or the outer layer of coating every time
The thickness of coating is less than 10 microns.
Preparation method the most according to claim 6, it is characterised in that described dried in vacuum or
Nitrogen or noble gas are carried out.
Preparation method the most according to claim 6, it is characterised in that also wrap in described step S200
Include to dissolve the material of outer coating and obtain coating solution, then use described coating solution to carry out impregnating or spraying
The step being coated with, the mass percent of the material of wherein said coating solution ectomesoderm coating is not more than 5%.
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| CN108814667B (en) * | 2018-02-12 | 2020-12-11 | 东莞市奥慧捷医疗器械有限公司 | Subcutaneous suturing nail and preparation method thereof |
| CN108814766B (en) * | 2018-03-15 | 2020-12-11 | 东莞市奥慧捷医疗器械有限公司 | Hernia patch fixing nail and preparation method thereof |
| CN114177343A (en) * | 2021-11-12 | 2022-03-15 | 长春圣博玛生物材料有限公司 | Suture, preparation method and medical braided fabric |
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| CN103374208A (en) * | 2012-04-24 | 2013-10-30 | 苏州舒新医疗器械有限公司 | Gradient degradable polymeric material and preparation method thereof |
| CN103933620A (en) * | 2014-04-09 | 2014-07-23 | 北京颐合恒瑞医疗科技有限公司 | Absorbable skin suturing nail and preparation method thereof |
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| US8323333B2 (en) * | 2005-03-03 | 2012-12-04 | Icon Medical Corp. | Fragile structure protective coating |
| AU2012220537A1 (en) * | 2011-02-23 | 2013-08-29 | Ams Research Corporation | Pelvic implant and therapeutic agent system and method |
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| CN103374208A (en) * | 2012-04-24 | 2013-10-30 | 苏州舒新医疗器械有限公司 | Gradient degradable polymeric material and preparation method thereof |
| CN103933620A (en) * | 2014-04-09 | 2014-07-23 | 北京颐合恒瑞医疗科技有限公司 | Absorbable skin suturing nail and preparation method thereof |
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