CN106823120A - A kind of preparation method of the degradable radioactive particle chain with shape memory function - Google Patents
A kind of preparation method of the degradable radioactive particle chain with shape memory function Download PDFInfo
- Publication number
- CN106823120A CN106823120A CN201710060177.4A CN201710060177A CN106823120A CN 106823120 A CN106823120 A CN 106823120A CN 201710060177 A CN201710060177 A CN 201710060177A CN 106823120 A CN106823120 A CN 106823120A
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- Prior art keywords
- tubing
- radioactive particle
- particle chain
- preparation
- shape memory
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- 230000002285 radioactive effect Effects 0.000 title claims abstract description 106
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- 230000006386 memory function Effects 0.000 title claims abstract description 21
- 239000004632 polycaprolactone Substances 0.000 claims abstract description 45
- 229920001610 polycaprolactone Polymers 0.000 claims abstract description 45
- 239000000463 material Substances 0.000 claims abstract description 36
- 238000010438 heat treatment Methods 0.000 claims abstract description 11
- 238000000034 method Methods 0.000 claims abstract description 11
- 238000001816 cooling Methods 0.000 claims abstract description 10
- 229920003023 plastic Polymers 0.000 claims abstract description 4
- 239000004033 plastic Substances 0.000 claims abstract description 4
- 239000000155 melt Substances 0.000 claims abstract description 3
- 239000000945 filler Substances 0.000 claims description 18
- 239000004014 plasticizer Substances 0.000 claims description 14
- QZCLKYGREBVARF-UHFFFAOYSA-N Acetyl tributyl citrate Chemical compound CCCCOC(=O)CC(C(=O)OCCCC)(OC(C)=O)CC(=O)OCCCC QZCLKYGREBVARF-UHFFFAOYSA-N 0.000 claims description 9
- 230000000712 assembly Effects 0.000 claims description 8
- 238000000429 assembly Methods 0.000 claims description 8
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 7
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 6
- 239000011256 inorganic filler Substances 0.000 claims description 6
- 229910003475 inorganic filler Inorganic materials 0.000 claims description 6
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 claims description 6
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 5
- 229920000642 polymer Polymers 0.000 claims description 5
- 229910000019 calcium carbonate Inorganic materials 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- 229920000954 Polyglycolide Polymers 0.000 claims description 3
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 3
- 229910052581 Si3N4 Inorganic materials 0.000 claims description 3
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims description 3
- 229910021502 aluminium hydroxide Inorganic materials 0.000 claims description 3
- 239000006229 carbon black Substances 0.000 claims description 3
- 239000001913 cellulose Substances 0.000 claims description 3
- 229920002678 cellulose Polymers 0.000 claims description 3
- 150000002148 esters Chemical class 0.000 claims description 3
- 239000012530 fluid Substances 0.000 claims description 3
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims description 3
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 0.000 claims description 3
- 239000004633 polyglycolic acid Substances 0.000 claims description 3
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 3
- HQVNEWCFYHHQES-UHFFFAOYSA-N silicon nitride Chemical compound N12[Si]34N5[Si]62N3[Si]51N64 HQVNEWCFYHHQES-UHFFFAOYSA-N 0.000 claims description 3
- 239000004359 castor oil Substances 0.000 claims description 2
- 235000019438 castor oil Nutrition 0.000 claims description 2
- 239000003240 coconut oil Substances 0.000 claims description 2
- 235000019864 coconut oil Nutrition 0.000 claims description 2
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 2
- 239000000843 powder Substances 0.000 claims 1
- 238000000465 moulding Methods 0.000 abstract description 12
- 238000007493 shaping process Methods 0.000 abstract description 7
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 206010028980 Neoplasm Diseases 0.000 description 13
- 238000002513 implantation Methods 0.000 description 7
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- 210000001519 tissue Anatomy 0.000 description 6
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- 238000001356 surgical procedure Methods 0.000 description 3
- 229920002472 Starch Polymers 0.000 description 2
- 239000000560 biocompatible material Substances 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 231100000518 lethal Toxicity 0.000 description 2
- 230000001665 lethal effect Effects 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 235000019198 oils Nutrition 0.000 description 2
- 230000002035 prolonged effect Effects 0.000 description 2
- 239000008107 starch Substances 0.000 description 2
- 235000019698 starch Nutrition 0.000 description 2
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 description 1
- 206010003694 Atrophy Diseases 0.000 description 1
- 235000013162 Cocos nucifera Nutrition 0.000 description 1
- 244000060011 Cocos nucifera Species 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 235000004443 Ricinus communis Nutrition 0.000 description 1
- 240000000528 Ricinus communis Species 0.000 description 1
- 229920008262 Thermoplastic starch Polymers 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 229940072056 alginate Drugs 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 230000037444 atrophy Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 231100000209 biodegradability test Toxicity 0.000 description 1
- 238000006065 biodegradation reaction Methods 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 229960001777 castor oil Drugs 0.000 description 1
- 230000007797 corrosion Effects 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000010894 electron beam technology Methods 0.000 description 1
- 125000004185 ester group Chemical group 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 230000009477 glass transition Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 125000000325 methylidene group Chemical group [H]C([H])=* 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 210000005170 neoplastic cell Anatomy 0.000 description 1
- 210000004940 nucleus Anatomy 0.000 description 1
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- 239000002504 physiological saline solution Substances 0.000 description 1
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- 230000010076 replication Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000007151 ring opening polymerisation reaction Methods 0.000 description 1
- 238000007711 solidification Methods 0.000 description 1
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- 239000000243 solution Substances 0.000 description 1
- 125000006850 spacer group Chemical group 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000004628 starch-based polymer Substances 0.000 description 1
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- 230000001629 suppression Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000001360 synchronised effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
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- 238000002604 ultrasonography Methods 0.000 description 1
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- PAPBSGBWRJIAAV-UHFFFAOYSA-N ε-Caprolactone Chemical group O=C1CCCCCO1 PAPBSGBWRJIAAV-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1007—Arrangements or means for the introduction of sources into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1014—Intracavitary radiation therapy
Abstract
The present invention relates to a kind of preparation method of radioactivity close-range treatment utensil, more particularly to a kind of preparation method of the degradable radioactive particle chain with shape memory function.Methods described comprises the following steps：(1) tubing is made：The mode that pipe material is extruded is fabricated to tubing, or is directly fabricated to tubing with pipe mold；(2) loading of radioactive particle：Radioactive particle is sequentially loaded into tubing；(3) it is molded：The tubing that will be equipped with radioactive particle is put into heating in the mould for be previously set shape, melts tubing, and the demoulding is plastic after cooling；The pipe material includes polycaprolactone (PCL).Not only manufacturing process is easy, Making programme is convenient for the method, product that is making can be with Repeat-heating/cooling shaping, and a plurality of particle chain combination that multiple can be spliced with the particle chain that PCL is main moulding material making, weave, merged, be cut into different shape, difference in functionality, to adapt to the clinical setting of complexity.
Description
Technical field
There is shape memory the present invention relates to a kind of preparation method of radioactivity close-range treatment utensil, more particularly to one kind
The preparation method of the degradable radioactive particle chain of function.
Background technology
Malignant tumour is always the major disease for threatening human health, is closely controlled between being organized using radioactive particle
It is the new technology that recent decades grow up to treat tumour.Radioactive particle is a kind of small radioactive sources, and the radioactive source is radioactivity
In titanium tube, two ends laser or electron beam technology weld to form sealed source isotope, and its size is generally external diameter 0.8mm,
Length is 4.5mm.The conventional nucleic of radioactive particle has192Ir、198Au、169Y、131Cs、103Pd and125I etc., especially103Pd
With125I.Radioactive particle is implanted directly into focus by close-range treatment, closely prolonged exposure, destroys the DNA double of neoplastic cell nuclei
Key, lethal or sub- lethal tumor cell, makes it lose replication capacity, so as to reach therapeutic purposes, while isotope ray used
Energy is relatively low, can be prevented effectively from ray and damage normal structure in way is irradiated.
Radioactive particle Implantation in Treating tumour is a kind of very effective treatment means, with suppression tumour efficiency
Height, dosage is reasonably distributed, convenient the advantages of form complementation with Operation cooperation, but there is also after radioactive prospecting instrument in tissue
Be subjected to displacement, seeds implanted operation it is cumbersome the shortcomings of.And since radioactive particle chain is radioactive particle close-range treatment application
The new technology of appearance, i.e., by the way that the multiple assemblies such as radioactive particle, image mark thing either physically or chemically are passed through into biofacies
Capacitive material (especially biodegradable) is assembled into particle chain.
The application of radioactive particle chain has the following advantages that：(1) no longer because position chanP after radioactive particle chain implantation
Or the knurl bodily form become etc. reason there is migration situation, make particle dose be distributed meet treatment planning systems (TPS) cloth source dose requirements.
(2) indication of radioactive prospecting instrument art is increased, especially tumor locus have crumbly texture, and such as tumor locus exist big
Amount body of gland, implant site is not suitable for the situation of single particle implantation.(3) radioactive particle chain typically all have preferably elasticity and
Mechanical performance, can so occur compliance deformation with the diminution of tumor tissues.(4) moulding material one of radioactive particle chain
As by biocompatible materials (especially Biodegradable material) make, Biodegradation Times several weeks of material, connect with tumour
The atrophy cycle phase occurred after being irradiated by radioactive particle is worked as, and normal structure is not influenceed after treatment end.(5) radioactive particle chain
The moulding material that uses so that radioactive particle not with tumor tissues directly contact, this avoid local organization because of overdosage
And the phenomenon that necroses.(6) particle chain is implanted into by implant system, can disposably realizes many radioactive particle layouts, subtracted
The exposure dose of implant surgery time and medical personnel is lacked.(7) radioactive particle chain assembling is completed by producer, facilitates user,
Improve added value of product.
The Chinese patent that the present inventor invented in the past is entitled《A kind of radioactive particle chain》Application publication number is
A kind of particle chain being wrapped to form as moulding material using hydrophilic alginate is proposed in CN103736201A, after implantation
Can finally be deformed with the diminution of tumor tissues and finally degraded with fast softening under wet environment in vivo, but this
Plant after particle chain softens in vivo and lack enough support forces, be only suitable for being implanted at the big tumour of tissue density, it is big for existing
Buret chamber, the tumour at body of gland position, this particle chain are easy to be subjected to displacement, and cause dose deviations.
The Chinese patent that the present inventor invented in the past is entitled《A kind of preparation method of radioactive particle chain》Application is open
Number to propose a kind of formed in mould particle chain preparation method in CN 103736200A, but this method needs to use solidification
Operation, it is impossible to one-shot forming, and the solution containing salinity is needed to use during forming operation, corrosion is easily caused to mould.
In view of drawbacks described above, the present inventor passes through prolonged research and practice obtains this creation finally.
The content of the invention
For the problem in background technology, the invention provides a kind of degradable radioactive grain with shape memory function
The preparation method of subchain, is used to overcome above-mentioned technological deficiency.
To achieve the above object, the present invention proposes following technical scheme：
A kind of preparation method of the degradable radioactive particle chain with shape memory function, it is characterised in that：The side
Method comprises the following steps：
(1) tubing is made：The mode that pipe material is extruded is fabricated to tubing, or is directly fabricated to pipe mold
Tubing；
(2) loading of radioactive particle：Radioactive particle is sequentially loaded into the tubing made by step (1)；
(3) it is molded：The tubing that will be equipped with radioactive particle is put into heating in the mould for be previously set shape, melts tubing
Change, the demoulding is plastic after cooling；
The pipe material includes polycaprolactone (PCL).
Further, the pipe material also includes filler and/or plasticizer；
Described filler includes inorganic filler and polymer filler, and described filler accounts for the integument proportion no more than 20%；
The plasticizer includes natural or synthetic fluid esters material, and the plasticizer accounts for the integument proportion and do not surpass
Cross 10%.
Further, the inorganic filler is calcium carbonate, calcium sulfate, hydroxyapatite, carbon black, silicon nitride, aluminium hydroxide
In one or more；
The polymer filler be PLA, polyglycolic acid, PVP, polyvinyl alcohol, polyethylene glycol,
One or more in starch, cellulose；
The plasticizer is ATBC, citroflex A-4, triacetyl glycerine, castor oil, coconut
One or more in oil.
Further, the step (2) also includes being loaded into other assemblies in tubing；
The other assemblies include distance member, grappling and label component；
Can successively be loaded in nonseptate mode between each component, or single component be reprinted predetermined in tubing
, there is interval between component in position.
Further, the internal diameter of the tubing is more than the maximum outside diameter in the radioactive particle and the other assemblies,
And difference≤the 0.4mm of the internal diameter of the tubing and the maximum outside diameter.
Further, the wall thickness 0.05mm-2mm of the tubing.
Further, in the step (3), tubing is heated to be not less than 60 DEG C；
- 10 minutes 1 second heat time of tubing.
Further, in the step (3), tubing is heated to 60-100 DEG C；
Preferably -1 minute 10 seconds heat time of the tubing.
The beneficial effects of the present invention are：
Present invention employs the degradation material PCL with shape memory function as moulding material, with PCL as it is main into
The particle chain that section bar material makes has the following advantages that：
1st, PCL has shape memory function, therefore, for particle chain of different shapes, can be by puncture needle once
Property complete implant surgery, especially the complicated tumour in position is, it is necessary to during using curvilinear particle chain, make the implantation hand of particle chain
Art becomes simple.
2nd, the shape memory function of PCL can provide the support force of enough different directions, especially body lumen, gland division
Tumour near position, is the support that particle chain that main moulding material makes simultaneously can be certain to tube chamber, body of gland holding with PCL
The particle chain of power, especially helical form or other complicated shapes, has stronger support force to the axial direction of chain, it is ensured that particle chain is implanted into
Post operation does not influence the normal physiological function of tube chamber, body of gland.
3rd, PCL has biological degradability, by the tune of the compositions such as the different fillers of molecular weight proportioning and accelerated degradation
Section, accomplishes that the radioactive dosage in particle chain discharges when finishing substantially, and also synchronous degradation is finished PCL.
4th, the fusing point of PCL is low, only 60 DEG C or so, and suitable medical personnel adjust particle at any time in even performing the operation before surgery
The shape and layout of chain, to tackle the various situations occurred during operation.
5th, PCL is that the particle chain of main moulding material can as needed form the combining structure of a plurality of particle chain.
It is that the particle chain preparation method that main moulding material makes has the following advantages that with PCL：
1st, manufacturing process is easy, it is only necessary to which one-time heating is that may be molded to product.
2nd, Making programme is convenient, and without using complex device, Production Time is very short, can operative site operation.
3rd, the product for making can be with Repeat-heating/cooling shaping.
4th, the particle chain that multiple PCL are main moulding material making can be spliced, weave, merge, being cut into not
The a plurality of particle chain combination of similar shape, difference in functionality, to adapt to the clinical setting of complexity.
Figure of description
Fig. 1 is a kind of preparation method flow of degradable radioactive particle chain with shape memory function of the invention
Figure.
Fig. 2 is that a kind of preparation method of degradable radioactive particle chain with shape memory function of the invention is obtained
Product structure figure.
In figure, 1- radioactive particles, 2- integuments, 3- distance members.
Specific embodiment
The invention provides a kind of preparation method of the degradable radioactive particle chain with shape memory function, such as Fig. 1
Shown, methods described includes following several steps：
1st, tubing is made：
After PCL is mixed with filler, plasticizer, PCL tubing is fabricated to the mode of extrusion, or directly use pipe mold
Tubing is fabricated to, the internal diameter of tubing matches with the external diameter of radioactive particle, the external diameter of general radioactive particle is 0.8mm, pipe
The internal diameter of material is 0.8mm-1.2mm, and pipe internal diameter is too small, cannot just load radioactive particle, and pipe internal diameter is excessive, radioactivity grain
Sub- " loaded " position is susceptible to skew；Tube wall thickness 0.05mm-2mm, the excessively thin meeting of tube wall causes particle chain mechanical support power not enough,
It is blocked up to increase cost, and can cause that particle chain is not suitable for being implanted into using the mode of puncture needle.After forming tubing, can be according to need
It is cut into appropriate length.
2nd, the loading of radioactive particle：
According to the requirement of prior design, the components such as radioactive particle, label, spacer are sequentially loaded into PCL pipes, respectively
Can successively be loaded in nonseptate mode between individual component, it is also possible to which single component is reprinted into the precalculated position in PCL pipes, group
There may be space between part, component can be successively pushed into load mode predetermined position in tubing with push rod, wherein pushing away
Shank diameter is less than pipe internal diameter, or by corresponding assembly successively seamlessly in insertion tubing, each component is successively in insertion process
Slip into precalculated position.
3rd, it is molded：
PCL pipes are put into the mould for be previously set shape and are heated to be not less than 60 DEG C, preferably 60-100 DEG C, optimal 70
DEG C, melt PCL pipes, the demoulding is plastic after cooling.The shaping of PCL pipes quickly, -10 minutes 1 second heat time, preferably 10
- 1 minute, the optimal 20 seconds second, you can complete forming process.Forming process can be repeated several times, and can assemble a plurality of particle chain
Form complicated particle chain structure.
Include at least a radioactive particle 1 and an integument using the degradable radioactive particle chain obtained by the above method
2, as shown in Figure 2.
The radioactive particle is radioactive source, and at least part of is wrapped up by the integument.
The wrapper material includes PCL.
Polycaprolactone, abbreviation PCL, thermoplasticity half typically as obtained from 6-caprolactone monomer via ring-opening polymerization
Crystalline polyester.PCL fusing points are 59~64 DEG C, and glass transition temperature is -60 DEG C, there is 5 nonpolar methylenes on its structural repeat unit
Base and a polar ester groups, thus with good pliability and processability, the particle chain of making then have shape memory and
Biological degradability.
The material of the integument also includes filler and/or plasticizer.
Described filler includes inorganic filler and polymer filler, and filler can be with reduces cost, the machine of raising wrapper material
Tool performance and regulation integument degradation time in vivo.The inorganic filler be calcium carbonate, calcium sulfate, hydroxyapatite,
Any one in carbon black, silicon nitride, aluminium hydroxide or any several mixtures constituted with arbitrary proportion, the polymerization
Thing filler is in PLA, polyglycolic acid, PVP, polyvinyl alcohol, polyethylene glycol, starch, cellulose
Any one or any several mixtures constituted with arbitrary proportion, described filler are accounted for the integument proportion and are no more than
20%.
The plasticizer includes natural or synthetic fluid esters material, and plasticizer has preferable compatibility with PCL, adjustable
Save the toughness of integument.The plasticizer is ATBC, citroflex A-4, triacetyl glycerine, castor-oil plant
Any one in oil, coconut oil or any several mixtures constituted with arbitrary proportion, the plasticizer account for the bag
Covering layer proportion is no more than 10%.
The degradable radioactive particle chain also includes an at least distance member 3, and the distance member is at least part of
It is wrapped in the integument, for optimizing the radioactive particle radiological dose, improving the radioactive particle chain mechanicalness
Can, the distance member material is biocompatible materials.
The degradable radioactive particle chain is linear, circular arc, annular, helical form, Y-shaped, cross, netted
In any one structure or any a plurality of particle chain combining structure.
The degradable radioactive particle chain also include having grappling radioactive particle chain position and/or mark and/or every
From the component of function.
Anchor assemblies are the positions for fixing particle chain, generally protrusion, may be located at any table of particle chain
Face, it is ensured that will not be subjected to displacement in tissue after particle chain implantation.Label is the impermeability material such as X-ray or CT, for
The position of particle chain is demarcated in operation using means such as X-ray, ultrasound, CT, label can be marked at the two ends of particle chain, also may be used
To be marked in every two gaps of adjacent radioactive particle.
To being mainly with the quality control that PCL is the particle chain that main moulding material makes：
1st, outward appearance detection：It is radioactive particle chain appearance uniform that main moulding material makes, radioactivity with PCL to make
Particle alignment is uniform, spacing distance unification.
2nd, puncture needle test：By linear, circular arc or other shaped form particle chains by No. 18 piercing needles, pass through
When without obvious resistance, keep complete by rear radioactive particle chain.
3rd, mechanical stability test：Radioactive particle chain (whatsoever shape) two ends are positioned on two pieces of planks, in
Between it is hanging, there is no the deformation produced by deadweight in radioactive particle chain, and born a heavy burden in the middle of chain still can without naked eyes after 0.1 gram
See deformation, show radioactive particle chain stable mechanical performance.
4th, shape-memory properties test：Radioactive particle chain is applied into certain external force to be allowed to deform, is put after removing external force
Penetrating property particle chain replys original shape, is embodied in, and circular arc or other shaped form particle chains are by energy after No. 18 piercing needles
Resile, radioactive particle chain (whatsoever shape) two ends are positioned on two pieces of planks, it is middle hanging, born a heavy burden in the middle of chain
Deformed after 2 grams, particle chain resiles after removing heavy burden, for spirality particle chain, particle chain is hung, bottom applies
Bear a heavy burden, bear a heavy burden 2 grams when there is elastic stretching, while screw diameter diminishes, helical form particle chain resiles when removing heavy burden.
5th, storage stability performance test：The radioactive particle chain that will be made is closed at 4 DEG C and at room temperature to be preserved one month,
Again to the test of its outward appearance, puncture needle test, measuring mechanical property, shape-memory properties test, as a result show, memory period is to each
Item performance is without significant change.
6th, biodegradability test：Radioactive particle chain is put into 37 DEG C of physiological saline, is dissipated with particle in particle chain
Open and no longer fragmentated as degradable standard in chain, moulding material rupture, it with PCL is main forming material that test result is
Expect that the radioactive particle chain degradation time for making is 10 months, meet clinical practice requirement.
For the ease of being further appreciated that to of the invention, examples provided below has done more detailed description to it.This
A little embodiments are not used for limiting the scope of the present invention or implementation principle only for narration, and protection scope of the present invention is still with right
It is required that be defined, including done on this basis obvious change or variation etc..
Embodiment 1：
Make tubing：PCL (molecular weight 50000) is individually added into extruder, internal diameter 0.8mm, wall thickness 0.2mm is fabricated to
Tubing.
The loading of radioactive particle：It is 0.8mm, length for 4.5mm by 10 external diameters125I radioactive particles are sequentially loaded into
In PCL pipes, tight between particle.
Shaping：It is loaded into125The PCL pipes of I radioactive particles are heated to 70 DEG C, after tube wall becomes transparent on hot plate
Stop heating, linear particle chain is formed after cooling.
Obtained radioactive particle chain is detected that outward appearance is linear, surface is uniform, can pass through No. 18 punctures
Syringe needle, radioactive particle chain two ends are positioned on two pieces of planks, and middle hanging, radioactive particle chain does not occur to be produced because of deadweight
Raw deformation, and deformation is still visible by naked eyes after 0.1 gram of heavy burden in the middle of chain, show that radioactive particle chain mechanical performance is steady
It is fixed, there is obvious flexural deformation after 2 grams of heavy burden in the middle of chain, linear is reverted to after removing heavy burden, show radioactive particle
Chain has shape memory function.
Embodiment 2：
Make tubing：By PCL (molecular weight 50000), PLA (PLA, molecular weight 5000), citroflex A-4
By 80:19:1 part by weight is added in extruder, is fabricated to internal diameter 0.8mm, the tubing of wall thickness 0.2mm.
The loading of radioactive particle：It is 0.8mm, length for 4.5mm by 10 external diameters125I radioactive particles are sequentially loaded into
In PCL pipes, tight between particle.
Shaping：It is loaded into125The PCL pipes of I radioactive particles heat mould 70 DEG C, 20 seconds in circular arc tubular die
Stop heating afterwards, the demoulding forms arc-shaped particle chain after cooling.
Obtained radioactive particle chain is detected, outward appearance is in circular arc, surface is uniform, can pass through No. 18 punctures
Syringe needle, and by still maintaining circular arc after puncture needle.Radioactive particle chain is hung, radioactive particle chain does not occur because of deadweight
And the deformation for producing, circular arc is still maintained, born a heavy burden in chain bottom and be still visible by naked eyes deformation after 0.1 gram, show radioactivity
, there is obvious flexural deformation in subchain stable mechanical performance, circular arc is straightened after 2 grams of heavy burden, and circle is reverted to after removing heavy burden
Arc, shows that radioactive particle chain has shape memory function.
Embodiment 3：
Make tubing：PCL (molecular weight 50000), nano-calcium carbonate, citroflex A-4 are pressed 90:5:5 weight
Amount ratio is added in extruder, is fabricated to internal diameter 0.8mm, the tubing of wall thickness 1mm.
The loading of radioactive particle：It is 0.8mm, length for 4.5mm by 20 external diameters125I radioactive particles are sequentially loaded into
In PCL pipes, 2mm is spaced between son per particle.
Shaping：It is loaded into125The PCL pipes of I radioactive particles are having been heated to 70 DEG C, the heating rod of a diameter of 10mm
Upper coiled, stops heating after winding, helical form particle chain is formed after the demoulding.
Obtained radioactive particle chain is detected, in the shape of a spiral, surface is uniform, by radioactive particle catenary suspension for outward appearance
Hang, radioactive particle chain do not occur the deformation produced by deadweight, still maintain helical form, born a heavy burden after 0.1 gram still in chain bottom
Deformation is visible by naked eyes, shows radioactive particle chain stable mechanical performance, obvious stretcher strain, spiral occur after 2 grams of heavy burden
Shape is straightened, and screw diameter diminishes, and spirality is recovered after removing heavy burden, shows that radioactive particle chain has shape memory work(
Can, and the radial support with spring-like, rebound performance, it is adapted to the implantation of tube chamber inner radiation particle.
Embodiment 4：
Make tubing：PCL (molecular weight 50000), thermoplastic starch, citroflex A-4 are pressed 80:15:5
Part by weight is added in extruder, is fabricated to internal diameter 0.8mm, the tubing of wall thickness 1mm.
The loading of radioactive particle：It is 0.8mm, length for 4.5mm by 20 external diameters125I radioactive particles are sequentially loaded into
In PCL pipes, 2mm is spaced between son per particle.
Shaping：It is loaded into125The PCL pipes of I radioactive particles are heated to 70 DEG C, after tube wall becomes transparent on hot plate
Stop heating, linear particle chain is formed after cooling.Two particle chains of forming are placed on hot plate, juxtaposition shape
Across, is heated to 70 DEG C and is molded again, and cross particle chain is formed after cooling.
Obtained radioactive particle chain is detected, outward appearance is in crosswise, surface is uniform, to single in crosswise particle chain
The detection method and result of an only particle chain are with embodiment 1.
Claims (8)
1. a kind of preparation method of the degradable radioactive particle chain with shape memory function, it is characterised in that：Methods described
Comprise the following steps：
(1) tubing is made：The mode that pipe material is extruded is fabricated to tubing, or is directly fabricated to pipe with pipe mold
Material；
(2) loading of radioactive particle：Radioactive particle is sequentially loaded into the tubing made by step (1)；
(3) it is molded：The tubing that will be equipped with radioactive particle is put into heating in the mould for be previously set shape, melts tubing,
The demoulding is plastic after cooling；
The pipe material includes polycaprolactone (PCL).
2. the preparation method of a kind of degradable radioactive particle chain with shape memory function according to claim 1,
It is characterized in that：The pipe material also includes filler and/or plasticizer；
Described filler includes inorganic filler and polymer filler, and described filler accounts for the integument proportion no more than 20%；
The plasticizer includes natural or synthetic fluid esters material, and the plasticizer accounts for the integument proportion and is no more than
10%.
3. the preparation method of a kind of degradable radioactive particle chain with shape memory function according to claim 2,
It is characterized in that：
The inorganic filler is the one kind or many in calcium carbonate, calcium sulfate, hydroxyapatite, carbon black, silicon nitride, aluminium hydroxide
Kind；
The polymer filler is PLA, polyglycolic acid, PVP, polyvinyl alcohol, polyethylene glycol, shallow lake
One or more in powder, cellulose；
The plasticizer is in ATBC, citroflex A-4, triacetyl glycerine, castor oil, coconut oil
One or more.
4. the preparation method of a kind of degradable radioactive particle chain with shape memory function according to claim 1,
It is characterized in that：The step (2) also includes being loaded into other assemblies in tubing；
The other assemblies include distance member, grappling and label component；
Can successively be loaded in nonseptate mode between each component, or single component is reprinted the pre-determined bit in tubing
Put, there is interval between component.
5. the preparation method of a kind of degradable radioactive particle chain with shape memory function according to claim 1,
It is characterized in that：
The internal diameter of the tubing is more than the maximum outside diameter in the radioactive particle and the other assemblies, and the tubing is interior
Footpath and the difference≤0.4mm of the maximum outside diameter.
6. the preparation side of a kind of degradable radioactive particle chain with shape memory function according to claim 1-5
Method, it is characterised in that：
The wall thickness 0.05mm-2mm of the tubing.
7. the preparation method of a kind of degradable radioactive particle chain with shape memory function according to claim 1,
It is characterized in that：
In the step (3), tubing is heated to be not less than 60 DEG C；
- 10 minutes 1 second heat time of tubing.
8. the preparation method of a kind of degradable radioactive particle chain with shape memory function according to claim 7,
It is characterized in that：
In the step (3), tubing is heated to 60-100 DEG C；
Preferably -1 minute 10 seconds heat time of the tubing.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111840586A (en) * | 2020-07-22 | 2020-10-30 | 原子高科股份有限公司 | Biodegradable radioactive particles, particle composition and preparation method |
| US20210015969A1 (en) * | 2019-07-19 | 2021-01-21 | Evonik Operations Gmbh | Rigid resorbable materials with polymer and organic fillers |
| CN113895920A (en) * | 2021-10-12 | 2022-01-07 | 山东卓业电子科技有限公司 | Method based on radioactive particle automatic loader |
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| US20040109823A1 (en) * | 2000-11-16 | 2004-06-10 | Microspherix Llc | Flexible and/or elastic brachytherapy seed or strand |
| CN1887364A (en) * | 2006-07-20 | 2007-01-03 | 中国科学院长春应用化学研究所 | Biodegradable medical extracorporeal fixing material possessing shape memory function |
| CN103736200A (en) * | 2013-12-31 | 2014-04-23 | 原子高科股份有限公司 | Preparation method of radioactive particle chain |
| CN103736201A (en) * | 2013-12-31 | 2014-04-23 | 原子高科股份有限公司 | Radioactive particle chain |
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| US20010044567A1 (en) * | 2000-01-25 | 2001-11-22 | Zamora Paul O. | Bioabsorbable brachytherapy device |
| US20040109823A1 (en) * | 2000-11-16 | 2004-06-10 | Microspherix Llc | Flexible and/or elastic brachytherapy seed or strand |
| CN1887364A (en) * | 2006-07-20 | 2007-01-03 | 中国科学院长春应用化学研究所 | Biodegradable medical extracorporeal fixing material possessing shape memory function |
| CN103736200A (en) * | 2013-12-31 | 2014-04-23 | 原子高科股份有限公司 | Preparation method of radioactive particle chain |
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| US20210015969A1 (en) * | 2019-07-19 | 2021-01-21 | Evonik Operations Gmbh | Rigid resorbable materials with polymer and organic fillers |
| CN111840586A (en) * | 2020-07-22 | 2020-10-30 | 原子高科股份有限公司 | Biodegradable radioactive particles, particle composition and preparation method |
| CN113895920A (en) * | 2021-10-12 | 2022-01-07 | 山东卓业电子科技有限公司 | Method based on radioactive particle automatic loader |
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| CN106823120B (en) | 2024-01-16 |
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