CN103705325A - Multilayer bionic intestinal stent and preparation method thereof - Google Patents
Multilayer bionic intestinal stent and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a multilayer bionic intestinal stent for treating intestinal diseases, belongs to biological medical textiles, and aims to overcome the defects that traditional metal intestinal stent is high in stress, causes intestinal tract secondary damage, cannot be directly used for treating intestinal diseased parts, and the like. The stent comprise at least three layers, the innermost layer 1 is a smooth medical polymer coating 0.05-0.25mm in thickness, the middle layer 2 is the tubular tent body, which is knitted and woven by medical polymer, with radial compression force of 30-240cN and a seamless tube wall structure, and the outermost layer 3 is a medicine film layer for treating the diseased parts. The stent has the advantages that the stent is excellent in mechanical performance and capable of realizing non-degradation, partial degradation and total degradation, degradation time is controllable, the pharmaceutical formulation of the outer layer is adjusted, and a mechanical model is built to allow the support force of the stent to be controllable.
Description
Technical field
The invention belongs to the special equipment of biologic medical textile field, especially relate to a kind of fabric pattern design and processing method utilized, obtain the multiple structure support that is used for the treatment of intestinal pathological changes.
Background technology
Colorectal cancer, is called for short " CRC ", is one of disease that in the world today, M & M is the highest.Surgical operation is the most popular method that is used for the treatment of this disease.As carrying out intestinal neostomy or abdominal, tumor resection, carries out the operation of intestinal end to end anastomosis.But the relapse rate that surgical operation causes and mortality rate be up to 4%-60%, 8.8%-27%.In addition, some patients do not possess physiology, the pathological conditions of abdominal, as old people, malignant tumor whole body shift, late case.Therefore, in recent years, the operation of knot rectum support is the clinical protocol for a kind of extensive employing of this type of patient.At present, the knot rectum support through FDA approval, only has metal self-expanding stent, is called for short " SEMS ".About the patent retrieval situation analysis of metal rack, as described in table 1, with metal memorial alloy nickel, titanium, adopt knitting skill to be processed into the metal self-expanding stent with self-expanding effect, coordinate intestinal endoscope and fluoroscopy, carry out stentplacement operation.But traditional metal support is only used for the treatment of malignant gastrointestinal carcinomatous obstruction, only play expansion and palliative treatment effect.And, also need to coordinate oral or injection chemotherapeutics, carry out systemic chemotherapy.Because chemotherapeutics is through oral, separated layer by layer through stomach, intestinal, muscular tissue, the active drug concentration that arrives tumor locus is very low.Meanwhile, because the Dose Problem of chemotherapeutics has played great injury to human normal cell and tissue.Therefore,, for colorectal cancer, urgent need will be captured a difficult problem for novel therapeutic technology.
Desirable support should have good organization's compatibility, can absorb, can local targeted therapy diseased region etc. performance.Adopting support to cover the technology of pharmaceutical film, is that targeting therapy on tumor technology is applied on intestinal support, makes support not only can play expansion intestinal, recovers human normal defecation; Meanwhile, the pharmaceutical film of rack surface can targeting therapy on tumor position.As in table 1, United States Patent (USP) (20060095124A1) is described is covered with foam coating, and the hydrops producing in the time of can expanding intestinal and absorb treatment intestinal pathological changes, reduces intestinal fistula.Carried stent as described in Chinese patent (1792380A, 2638761Y), this is a kind of in the outer technology that covers medication coat of self-expanding metal rack.Rack body remains metal memorial alloy.Metal self-expanding stent, because the stress of support own is excessive, causes secondary damage to diseased region own, directly causes intestinal fistula, indirectly causes peritonitis (being difficult to cure); In addition, the tinsel head end that forms support thrusts intestinal wall, causes granulation hyperplasia; Tumor sees through support space and again inwardly extends, and causes stent restenosis; And metal rack hardness is excessive, it is permanent non-degradation-type material.After operation, patient can not feel well, be especially kept in motion, and pain aggravation, this has also reduced patient's life quality; Even, due to pain, stop up again, perforation, slippage and infection, cause second operation rate high.
The patent retrieval of table 1 support is analyzed
Summary of the invention
The present invention is that to take the GB/T16886 of medical apparatus and instruments and ASTM F2063-05 be standard, summary of the invention is a kind of bionical intestinal support with multiple structure of design, be used for the treatment of esophagus to the intestinal pathological changes between anus, as esophageal tumor, colon, rectal neoplasm and optimum, malignant obstruction.Solve conventional stent and adopt metal alloy wires, stress own is excessive, causes problems such as intestinal secondary damage and many complication.Content of the present invention comprises: a kind of have an at least bionical intestinal support of three-decker, is respectively: innermost layer 1 is smooth medical polymer cavity coating, and thickness is 0.05-0.25mm, preferably 0.15mm; Intermediate layer 2, for medical grade polymer monofilament is by knitting, woven and weaving method, adopts different technological parameters, and can obtain radial compression force is the three-dimensional tubular bracket that 30-240cN, tube wall are jointless structure; Outermost layer 3 is for being used for the treatment of the pharmaceutical film layer of diseased region.Described support support integral body can realize and not degrade, Partial digestion and degradable, and by selecting different stent materials to control the degradation time of support integral body.Described support has good biomechanical property, as radial support power, compliance and circumferential tension power etc.
Support of the present invention can be used for the treatment of esophagus to the intestinal pathological changes between anus, patient, after severity extent, lesions position and three aspect diagnosis of individual variation, show that the selection of support is according to the indexs such as degradation time, medicine film formulation, stent size, supporting structure and mechanical property requirements that comprise material.The intermediate layer of described three layers of support preparation flow for first adopting method woven, knitting or braiding to prepare support, shapes and rear arrangement, prepares internal layer or the skin of support, after prepared by support, and terminal disinfection and preservation.The design and processes specifically adopting for the different state of an illness requires flow chart as shown in Figure 2; Support preparation flow figure as shown in Figure 3.
Support of the present invention has following characteristics: 1) support has good biomechanical property, as radial support power, compliance and circumferential tension power etc.; 2) support integral body can realize do not degrade, Partial digestion and degradable, and by selecting different stent materials to control the degradation time of support integral body; 3) support is outer for being loaded with the medicine film layer of medicine, and wherein pharmaceutical formulation is adjusted according to disease situation; 4) in practical application, needed model can be obtained by experiment statistics method.In knitting moulding process, and verified and sinking depth, fabric tension, yarn diameter and yarn tension are relevant.Relation between the rack forming technological parameter that the present invention draws and support radial support power, as an example, can design Different Diameter to the support of support force.The relational model of support radial compression force (RF) and sinking depth, fabric tension and yarn tension:
RF＝42.17-21*A-5.15B+1.3C+11.71D+3.17AB-3.33AC-6.68AD+1.47ABC-2.78ACD
Wherein: A is sinking depth, B is fabric tension, and C is yarn tension, and D is yarn diameter.
Described support innermost layer 1, is the medical polymer coating that is 0.05-0.25mm by thickness, and the material adopting can make medical polyurethane, silica gel, hydrogel, chitosan, polycarbonate-based.
Described support intermediate layer 2 is that medical grade polymer monofilament is the three-dimensional tubular bracket that 30-240cN, tube wall are jointless structure by radial compression force knitting, woven and that weaving method obtains.Wherein:
1) raw material that described support adopts is polymer filament, and modulus is high, intensity good, and the about 0.1-0.6mm of filament diameter, hot strength are greater than 400N/mm2, fracture strength and are greater than 600MPa, melt temperature and are less than 50% higher than 90 ℃, extension at break.
2) described support is three dimensional structure, adopts knitting, woven and weaving method acquisition, and pipe diameter is at 10-30mm, and radial compression force is 30-240cN.
Described support skin 3, described medicine film is nanostructured, fibre diameter is at 20-200nm.Can adopt any known method preparation to there is the medicine film layer of drug slow release function.As with disclosed method in Publication about Document:
[1]Zeng?J，Xu?XY，Chen?XS，et?a1.Biodegradable?electrospun?fibers?for?drug?del?ivery，Journalof?Controlled?Release，2003，92：227-231.
[2] high wise man. Chinese patent: a kind of method of coating target medicament particle with soft magnetic nanofilm. publication number: CN101353784A
The good medicine of medicament selection clinical effectiveness of described medicine film, requires, in organic solvent, to have good dissolubility.As the medicine for anticancer comprises: 5-fluorouracil, hydroxy camptothecin, paclitaxel, oxaliplatin, epirubicin, amycin, daunorubicin, mitomycin.
technical scheme
The invention provides a kind of bionical intestinal support with multiple structure, be achieved through the following technical solutions:
1. the innermost layer 1 of multiple structure intestinal support, is the medical polymer coating that is 0.05-0.25mm by thickness, and the material adopting can make medical polyurethane, silica gel, hydrogel, chitosan, polycarbonate-based.Coating process is: get the section of appropriate absorbable polymer or powder, molecular weight, in 5-20 ten thousand left and right, is dissolved in CH2C12, chloroform, oxolane, acetone, ethyl acetate, then, adopts hairbrush or spray gun uniform coating, to thickness be 0.05-0.25mm; Be positioned over vacuum drying oven, dry 12 hours of evacuation.
2. multiple structure intestinal support intermediate layer 2 is that medical grade polymer monofilament is the three-dimensional tubular bracket that 30-240cN, tube wall are jointless structure by radial compression force knitting, woven and that weaving method obtains.Wherein
(1) raw material that support adopts is polymer filament, and modulus is high, intensity good, and the about 0.1-0.6mm of filament diameter, hot strength are greater than 400N/mm2, fracture strength and are greater than 600MPa, melt temperature and are less than 50% higher than 90 ℃, extension at break.Selection material has poly-glycol carbonic acid, polyglycolic acid, polydioxanone, poly lactic-co-glycolic acid copolymer.Selection material and performance thereof as
Table 2:
Table 2 support monofilament material performance table
(2) claim support adopts knitting, woven and weaving method acquisition, and pipe diameter is at 10-30mm, and radial compression force is 30-240cN,
Claim technique is:
A) knitting: adopt plane No. 10-18 knitting circular knitting machine.Technique arranges: syringe bore is at 15-50mm, 16-54 pin, and traction force 0.5-3Kgf on tissue machine, sinking depth 2-5mm, compiles fast 1-5m/min.Described supporting structure is latitude flat structure, two-sided flat needle structure, plaiting structure.Support is indulged close 15-40 line/5cm, horizontal close 10-35 stringer/5cm, gross density 800-1500 coil/25cm
2, loop length 3-6mm, underfill coefficient 8-20, fiber volume fraction 15-30%.
B) weaving: adopt rigid rapier 1 * 4 box-loom.Basic organization is 3 times twills on 2 times twills on plain weave, 2,1, and warp monofilament line density is 0.1-0.5mm, and weft monofilament line density is 0.3-0.6mm.End count is 80-120r/10em, and filling density is 100-150r/10em, and weaving speed is 30-60r/min.
C) weaving: adopt 16-54 ingot braider.Adopt rhombus braiding structure (1/1 pilotaxitic texture), regular braiding structure (2/2 pilotaxitic texture) and three kinds of structures of He Gelisi (3/3 pilotaxitic texture), knitting angle is 30-60 °.Support tube wall thickness 0.3-0.5mm, pitch 5-10mm, axial density 15-20 bundle/cm, Unit Weight 0.03-0.06g/cm
2.
D) described support, radial support power 60-240cN, longitudinal stretching brute force is greater than 20MPa, and cross directional stretch brute force is greater than 10MPa.
(3) sizing of support and rear arrangement;
Fabric, in braiding, can be inevitably infected with the impurity such as machine oil, dust, and due to the residual stress after monofilament material braiding.Therefore must carry out pretreatment and thermal finalization to sample, preprocessing process mainly comprises following step:
1) decontamination of fabric arranges; Adopt oxalic acid (adipic acid) as detergent herein.70 degree under 4% concentration, standing 30 minutes.After completing
For several times clean with water purification, to remove the chemical solution of fabric face.
2) deep layer is cleaned; In distilled water, ultrasonic waves for cleaning is 20 minutes, guarantees that fabric face is further clean, interfibrous dirt and front
Possible residual removal in twice chemical treatment method.
3) sizing; Be placed in vacuum drying oven, under 70 ℃ of conditions, place 30 minutes nitrogen protection drying and shaping.
3. the preparation of the outermost layer 3 of multilamellar bioabsorbable stent;
The antitumor drug such as described medicine film formulation 5-fluorouracil, paclitaxel, oxaliplatin, hydroxy camptothecin, drug level 8%-16%, protein polymer concentration is 10-30%.Use solvent is acetone, chloroform, 98% concentration formic acid, acetone/chloroform=3/1, and in V/V, solvent is analytical pure, under 2500 rotating speeds, stirs 10mins, and ultrasonic dispersion 1 hour obtains homodisperse medicine spinning liquid.25 ℃ of spinning condition room temperatures, relative humidity 45-55%.Before carrying out electrostatic spinning, first by the main body rack preparing, be enclosed within on the roller bearing of homemade electrostatic spinning machine.Then, spinning liquid is injected to Static Spinning syringe, voltage 15-30KV, pole span 100-300mm, flow velocity 1-10ml/h, spinning nozzle caliber size is 0.3-0.8mm.Final molding medicine film thickness is at 800-1300 μ m.
beneficial effect
The beneficial effect that the present invention may obtain, is:
1) can greatly shorten operating time, reduce operation risk;
2) reduce systemic chemotherapy or radiotherapy, improve quality of life of patients;
3) avoid causing because surgical condition is immature in art and postoperative patient death;
4) the fast quick-recovery patient's of energy physiological function, coordinates targeted drug directly to treat tumor locus;
5) support can directly be absorbed by the body, and without second operation, takes out support;
6) make to tie operation on rectum operation and become simple, be easy to study and promote.
7) realize the early stage Patients with Colorectal Cancer of minimally-invasive treatment, for end-stage patients strive for surgical condition and continuity patients ' lives.
Accompanying drawing explanation
Fig. 1 support is selected flow chart;
Fig. 2 support preparation flow figure;
Fig. 3 has the bionical intestinal support schematic diagram of multiple structure, in figure: 1 – internal chamber wall coating, 2 – three dimensional structure supports, 3 – pharmaceutical films, 4 – rack bores;
The bending rigidity test of Fig. 4 absorbable polymer monofilament;
The tensile property contrast of Fig. 5 absorbable polymer monofilament and common PP and PET;
The material plasticity performance test of Fig. 6 absorbable polymer monofilament;
The radial compressive property comparison of Fig. 7 support of the present invention and metal rack;
The circumferential tension Performance Ratio of Fig. 8 support of the present invention and metal rack;
The pharmaceutical film scanning electron microscope (SEM) photograph of Fig. 9 drug stent and different formulations;
The pharmaceutical film elution profiles of Figure 10 different formulations;
the specific embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment are only not used in and limit the scope of the invention for the present invention is described.In addition should be understood that those skilled in the art can make various changes or modifications the present invention after having read the content of the present invention's instruction, these equivalent form of values fall within the application's appended claims limited range equally.
1. with knitting method, prepare support;
1) timbering material;
A Medical rack raw material, polymer filament, modulus is high, intensity, and the about 0.1-0.6mm of filament diameter, hot strength are greater than 400N/mm
2, fracture strength is greater than 600MPa, melt temperature and is less than 40% higher than 90 ℃, extension at break.Selection material has poly-glycol carbonic acid, polyglycolic acid, polydioxanone, poly lactic-co-glycolic acid copolymer.As shown in Figure 2,3, 4, in the present embodiment, selected medical grade polymer bending rigidity is functional, and maximum bending rigidity is 0.8gf*cm
2; Maximum ultimate strength reaches 37N, extension at break 45%; The plastic property test demonstration of selected absorbable polymer monofilament, before fracture, this material does not have obvious plastic deformation point, has good plasticity_resistant deformation.
2) moulding process;
Adopt knitted small machine, with reference to technique setting: syringe bore between 15-50mm, 16-54 pin, on tissue machine, traction force is at 0.5-3kgf, sinking depth 2-5 millimeter, compiles fast 1-5 m/min.Obtain the main part of support.Three dimensional structure stent diameter is at 10-30mm.Support is vertical close at 15-40 line/5cm, and horizontal close at 10-35 stringer/5cm, gross density is at 800-1500 coil/25cm2, and loop length is at 3-6mm, and for coefficient of fullness is at 8-20, fiber volume fraction is at 15-30%.Radial support power is at 30-240cN, and longitudinal stretching brute force is greater than 20MPa, and cross directional stretch brute force is greater than 10MPa.In the present embodiment, prepared support radial compressive property test experiments demonstration, the radial support power of support maximum can reach 400cN, and has good fatigue resistance.In the present embodiment, as shown in Figure 6,7, the knitting support radial support power of setting up and the relational model of technological parameter, drawn the relation of knitting parameter and support radial support power.As the different gastrointestinal tract support radial support power contrasts of Tanaka et al at document [1] report, the bracket leg support force obtaining in the embodiment of the present invention is obviously better than other support.
2. the preparation of medicine film;
Described medicine film formulation 5-fluorouracil is 20mg, and wool protein, PLLA polymer concentration are 20%.Use solvent is acetone, chloroform, 98% concentration formic acid, acetone/chloroform=3/1, and in V/V, solvent is analytical pure, under 2500 rotating speeds, stirs 10mins, and ultrasonic dispersion 1 hour obtains homodisperse medicine spinning liquid.25 ℃ of spinning condition room temperatures, relative humidity 45-55%.Before carrying out electrostatic spinning, first by the main body rack preparing, be enclosed within on the roller bearing of homemade electrostatic spinning machine.Then, spinning liquid is injected to Static Spinning syringe, voltage 15-30KV, pole span 100-300mm, flow velocity 1-10ml/h, spinning nozzle caliber size is 0.3-0.8mm.Final molding medicine film thickness is at 800-1300 μ m.
3. support internal layer;
Rack bore wall coating medical level polyurethane solutions, brushes with fine, soft fur the internal chamber wall that the hydrogel solution that is 4% by concentration is evenly coated to support, then will prop up and be placed on 60 ℃ of vacuum drying ovens oven dry 30 minutes, repeats aforesaid operations three times.
1. with weaving method, prepare support;
1) timbering material;
A kind of Medical rack raw material, polymer filament, modulus is high, intensity, the about 0.1-0.6mm of filament diameter, hot strength be greater than 400N/mm2, fracture strength be greater than 600MPa, melt temperature higher than 90 ℃, extension at break be less than 40%, the bio-absorbable phase is greater than 60 days.Selection material has poly-glycol carbonic acid, polyglycolic acid, polydioxanone, poly lactic-co-glycolic acid copolymer.As shown in Figure 2,3, 4, in the present embodiment, selected absorbable polymer bending rigidity is functional, and maximum bending rigidity is 0.8gf*cm2; Maximum ultimate strength reaches 37N, extension at break 45%; The plastic property test demonstration of selected absorbable polymer monofilament, before fracture, this material does not have obvious plastic deformation point, has good plasticity_resistant deformation.
2) moulding process;
Weaving: adopt 16-54 ingot braider, adopt rhombus braiding structure (1/1 pilotaxitic texture), regular braiding structure (2/2 pilotaxitic texture) and three kinds of structures of He Gelisi (3/3 pilotaxitic texture), knitting angle is 30-60 °.Support tube wall thickness 0.3-1.5mm, pitch 5-10mm, axial density 15-20 bundle/cm, Unit Weight 0.03-0.06g.Institute's acquisition support is after thermal finalization, and radial support power is at 30-240cN, and longitudinal stretching brute force is greater than 20MPa, and cross directional stretch brute force is greater than 10MPa.
2. the preparation of nanometer medicine film;
Described medicine film formulation 5-fluorouracil is 20mg, 30mg calcium folinate, and wool protein, PLLA polymer concentration are 20%.Use solvent is acetone, chloroform, 98% concentration formic acid, acetone/chloroform=3/1, and in V/V, solvent is analytical pure, under 2500 rotating speeds, stirs 10mins, and ultrasonic dispersion 1 hour obtains homodisperse medicine spinning liquid.25 ℃ of spinning condition room temperatures, relative humidity 45-55%.Before carrying out electrostatic spinning, first by the main body rack preparing, be enclosed within on the roller bearing of homemade electrostatic spinning machine.Then, spinning liquid is injected to Static Spinning syringe, voltage 15-30KV, pole span 100-300mm, flow velocity 1-10ml/h, spinning nozzle caliber size is 0.3-0.8mm.Final molding medicine film thickness is at 800-1300 μ m.
3. prepare support internal layer isolating membrane;
Rack bore wall coating medical level polyurethane solutions, brushes with fine, soft fur the internal chamber wall that the polyurethane solutions that is 6% by concentration is evenly coated to support, then will prop up and be placed on 70 ℃ of vacuum drying ovens oven dry 40 minutes, repeats aforesaid operations three times.
1. by woven method, prepare support;
1) timbering material;
A Medical rack raw material, polymer filament, modulus is high, intensity, and the about 0.1-0.6mm of filament diameter, hot strength are greater than 400N/mm
2, fracture strength be greater than 600MPa, melt temperature higher than 90 ℃, extension at break be less than 40%, the bio-absorbable phase is greater than 90 days.Selection material has poly-glycol carbonic acid, polyglycolic acid, polydioxanone, poly lactic-co-glycolic acid copolymer.As shown in Figure 2,3, 4, in the present embodiment, selected medical polymer bending rigidity is functional, and maximum bending rigidity is 0.8gf*cm
2; Maximum ultimate strength reaches 37N, extension at break 45%; The plastic property test demonstration of selected absorbable polymer monofilament, before fracture, this material does not have obvious plastic deformation point, has good plasticity_resistant deformation.
2) moulding process;
Adopt rigid rapier 1 * 4 box-loom, basic organization is 3 times twills on 2 times twills on plain weave, 2,1, and warp monofilament line density is 0.1-0.5mm, and weft monofilament line density is 0.3-0.6mm.End count is 80-120r/10cm, and filling density is 100-150r/10cm, and weaving speed is 30-60r/min.Radial support power is at 60-240cN, and longitudinal stretching brute force is greater than 20MPa, and cross directional stretch brute force is greater than 10MPa.
2. the preparation of medicine film;
Described medicine film formulation 5-fluorouracil is 20mg, oxaliplatin 30mg, and calcium folinate 20mg, fibroin albumen, PLLA polymer concentration are 20%.Use solvent is acetone, chloroform, 98% concentration formic acid, acetone/chloroform=3/1, and in V/V, solvent is analytical pure, under 2500 rotating speeds, stirs 10mins, and ultrasonic dispersion 1 hour obtains homodisperse medicine spinning liquid.25 ℃ of spinning condition room temperatures, relative humidity 45-55%.Before carrying out electrostatic spinning, first by the main body rack preparing, be enclosed within on the roller bearing of homemade electrostatic spinning machine.Then, spinning liquid is injected to Static Spinning syringe, voltage 15-30KV, pole span 100-300mm, flow velocity 1-10ml/h, spinning nozzle caliber size is 0.3-0.8mm.Final molding medicine film thickness is at 800-1300 μ m.
3. the preparation of support internal layer;
Rack bore wall coating medical level polyurethane solutions, brushes with fine, soft fur the internal chamber wall that the chitosan solution that is 5% by concentration is evenly coated to support, then will prop up and be placed on 70 ℃ of vacuum drying ovens oven dry 30 minutes, repeats aforesaid operations three times.
Claims (7)
1. there is an at least bionical intestinal support for three-decker, be respectively: innermost layer 1 is smooth medical polymer cavity coating, and thickness is 0.05-0.25mm, is preferably 0.15mm; Intermediate layer 2, for medical grade polymer monofilament is by knitting, woven and weaving method, adopts different technological parameters, and can obtain radial compression force is the three-dimensional tubular bracket that 30-240cN, tube wall are jointless structure; Outermost layer 3 is for being used for the treatment of the thin layer of diseased region.
2. described in support support integral body can realize do not degrade, Partial digestion and degradable, and by selecting different stent materials to control the degradation time of support integral body; State support and there is good biomechanical property, as radial support power, compliance and circumferential tension power etc.
3. described in, support can be used for the treatment of esophagus to the intestinal pathological changes between anus; Patient, after severity extent, lesions position and three aspect diagnosis of individual variation, show that the selection of support is according to the indexs such as degradation time, medicine film formulation, stent size, supporting structure and mechanical property requirements that comprise material; The intermediate layer of described three layers of support preparation flow for adopting method woven, knitting or braiding to prepare support, shapes and rear arrangement, prepares internal layer or the skin of support, after prepared by support, and terminal disinfection and preservation.
4. described in there is certain predictable relationship model between knitting, woven and weaving parameter and support radial support power in the moulding process of support, can design Different Diameter to the support of support force; In knitting moulding process, in the present invention, experiment statistics result is the relational model of support radial compression force (RF) and sinking depth, fabric tension and yarn tension, as follows:
RF＝42.17-21*A-5.15B+1.3C+11.71D+3.17AB-3.33AC-6.68AD+1.47ABC-2.78ACD
Wherein: A is sinking depth, B is fabric tension, and C is yarn tension, and D is yarn diameter.
5. described in, support innermost layer 1 is medical polymer cavity coating, and thickness is 0.05-0.25mm, preferably 0.15mm; Claim coating process is: get appropriate medical polymer section or powder, molecular weight, at 5-20 ten thousand, is dissolved in CH
2c1
2, in chloroform, oxolane, acetone, ethyl acetate, then, adopt hairbrush or spray gun uniform coating.
6. described in, support intermediate layer 2 is that medical grade polymer monofilament is that 30-240cN, tube wall are seamless three dimensional structure tubular bracket by radial compression force knitting, woven and that weaving method obtains:
(1) raw material that support adopts is polymer filament, and modulus is high, intensity good, and the about 0.1-0.6mm of filament diameter, hot strength are greater than 400N/mm2, fracture strength and are greater than 600MPa, melt temperature and are less than 50% higher than 90 ℃, extension at break;
(2) support adopts knitting, woven and weaving method acquisition, and pipe diameter is at 10-30mm, and radial compression force is 30-240cN, and concrete technology is:
1) knitting: adopt plane No. 10-18 knitting circular knitting machine.Technique arranges: syringe bore is at 15-50mm, 16-54 pin, and traction force 0.5-3Kgf on tissue machine, sinking depth 2-5mm, compiles fast 1-5m/min.Described supporting structure is latitude flat structure, two-sided flat needle structure, plaiting structure.Support is indulged close 15-40 line/5cm, horizontal close 10-35 stringer/5cm, gross density 800-1500 coil/25cm
2, loop length 3-6mm, underfill coefficient 8-20, fiber volume fraction 15-30%;
2) weaving: adopt rigid rapier 1 * 4 box-loom.Basic organization is 3 times twills on 2 times twills on plain weave, 2,1, and warp monofilament line density is 0.1-0.5mm, and weft monofilament line density is 0.3-0.6mm.End count is 80-120r/10cm, and filling density is 100-150r/10cm, and weaving speed is 30-60r/min;
3) weaving: adopt 16-54 ingot braider.Adopt rhombus braiding structure (1/1 pilotaxitic texture), regular braiding structure (2/2 pilotaxitic texture) and three kinds of structures of He Gelisi (3/3 pilotaxitic texture), knitting angle is 30-60 °.Support tube wall thickness 0.3-0.5mm, pitch 5-10mm, axial density 15-20 bundle/cm, Unit Weight 0.03-0.06g/cm
2;
4) described support, radial support power 60-240cN, longitudinal stretching brute force is greater than 20MPa, and cross directional stretch brute force is greater than 10MPa.
7. the pharmaceutical film that support outer 3 obtains for passing through 15-30KV high-voltage electrostatic spinning method according to claim 1, medicine film is 20-100nm nanostructured, can improve the speed that medicine film discharges medicine; Claim technique is: adopt high-voltage electrostatic spinning technology, prepare pharmaceutical film; Voltage 15-30KV, pole span 100-300mm, solvent is acetone, chloroform, 98% concentration formic acid, solution concentration, flow velocity 1-10m1/h, spinning nozzle caliber size is 0.3-0.8mm, the antitumor drug such as described medicine film formulation 5-fluorouracil, paclitaxel, oxaliplatin, hydroxy camptothecin, drug level 8%-16%, final molding medicine film thickness is at 800-1300 μ m.
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| CN107073176A (en) * | 2014-06-09 | 2017-08-18 | 康奈尔大学 | Implantable treatment delivery system and its method |
| CN107536658A (en) * | 2016-06-28 | 2018-01-05 | 微创心脉医疗科技（上海）有限公司 | Overlay film frame and its manufacture method |
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