CN100391556C - Radioactive esophagus rack and its making process - Google Patents

Radioactive esophagus rack and its making process Download PDF

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Publication number
CN100391556C
CN100391556C CNB021360154A CN02136015A CN100391556C CN 100391556 C CN100391556 C CN 100391556C CN B021360154 A CNB021360154 A CN B021360154A CN 02136015 A CN02136015 A CN 02136015A CN 100391556 C CN100391556 C CN 100391556C
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China
Prior art keywords
coating
radioactive
esophagus
esophageal
coating material
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CNB021360154A
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CN1389276A (en
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吴胜伟
李文新
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SHANGHAI INST OF ATOMIC NUCLEU
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SHANGHAI INST OF ATOMIC NUCLEU
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Abstract

The present invention discloses a novel medical appliance, namely a radioactive esophageal bracket, and a manufacturing method thereof. The present invention comprises five procedures: preparing surface coating material; mixing <32>P and the coating material; brushing a radioactive coating layer; brushing a protective layer; solidifying. Firstly, a coating material solution used for being coated on the surface of the esophageal bracket is prepared; secondly, a <32>P-sodium phosphate solution and the coating material solution are evenly mixed, and then are evenly coated on the surface of the esophageal bracket, which is coated with the protective layer after being dried; finally, a film is formed by solidifying, so that the <32>P is firmly combined on the surface of the esophageal bracket. The radioactive esophageal bracket has the effect of restoring swallow capability through supporting the esophagus by a bracket, and has the effect of treating esophageal cancer through killing cancer cells by radioactive rays.

Description

Radioactive esophagus rack and preparation method thereof
Technical field
The present invention relates to a kind of radioactive esophagus rack that is used for esophageal carcinoma therapy and preparation method thereof.
Background technology
According to the investigation of the United Nations health organization, the M ﹠ M of the Chinese esophageal carcinoma all occupies first place in the world, and the district occurred frequently of the esophageal carcinoma especially, more domestic areas.Patient with esophageal carcinoma is owing to tumor propagation, local inflammation edema cause esophagostenosis, and dysphagia influences patient's nutrition absorption.
The Therapeutic Method of the esophageal carcinoma mainly contains following several at present:
1. operation
By the ocal resection tissue.This is a most frequently used method before this, and the early stage patient with esophageal carcinoma of centering has obvious effect.But have surgical contraindication for some patient, and operation is also very big to patient's wound.
2. radiotherapy
By external exposure or internal radiation the patient tumors position is shone, the lethal effect of cancerous cell is reached the effect of treatment by ray.But the method is because exposure dose and irradiation area are difficult to control, thereby causes also normal cell being had lethal effect when killing and wounding cancerous cell, and radiotherapy simultaneously is long the course of treatment, to patient's feed influence greatly, reduced patient's quality of life.
3. chemotherapy
For the late esophagus cancer patient, chemotherapy has certain curative effect, but chemotherapy the time, also very big to the side effect of health.
4. Esophageal Stent implantation
In esophagus, implant support, open esophagus, recover patient's swallow with mechanical support effect.
Esophageal Stent has two big classes: a class is a silica gel support, and another kind of is the self-inflated metal rack.The former is thick because of implantation device, and the patient suffering is big during implantation, seldom uses, and latter's esophagus self-inflated metal rack (SEMS) mainly contains 4 types from textural classification:
1.Wallstent support
Constitute the mesh tubular structure by the stainless steel alloy silk that is used to perform the operation, diameter 1.4cm~2.0cm when expanding fully, length available 5.3cm~10.6cm, inserter is put in compression, and length increases internal diameter and reduces.The internal diameter that implants increases, and contraction in length, modified model are dumbbell shapeds, and body is coated with the covered stnet of silica gel, is the self-inflated metal rack (SFMS) that is used for esophagus the earliest.
2. rustless steel self-inflated metal rack
Claim " Z " type support again.Curve a plurality of " Z " shaped steel silk with the medical stainless steel silk, the about 5cm of each Z-shape steel filament length, several Z-shape steel silks are interconnected into a circle and form a joint, and the long 2cm of every saving is combined into an intact stent more than 2 joints.Surface-coated double-deck macromolecule silicone rubber has elasticity and pliability preferably.Centre or partial node support are equipped with " agnail " with anti-slip.Characteristics: full tunicle can prevent that tumor from growing to intracavity; The space is big between the Z-shape steel silk, and its expansive force is strong, can reset after the implantation; It is convenient, recyclable to extract; It is easy to insert process.
3. memory metal support
For the nickel-titanium memory metal is made.Shape memory function and excellent elasticity are arranged, below 4 ℃ the time, can dwindle distortion arbitrarily and nonelastic; When temperature>30 ℃, deployable recovery elasticity of support and original design diameter, dilating effect is lasting.So it is woven into tubular, in the thin footpath placement device of packing into after the compression, after discharging in vivo, body temperature can arouse its memory to shape, its tubular original shape of very fast recovery, narrow section is strutted (length 2.0cm~15cm, diameter 1.2cm~2.3cm).There are two types: not covered stnet and covered stnet.The outer most of monolayer silicon rubber that covers of covered stnet has acidproof corrosion-resistant effect.Its support and tissue biocompatibility are good, and rely on upper and lower side to expose the weaving manner of mesh, guarantee that support has support force and anti-displacement capacity preferably, have along wriggling property with esophagus simultaneously.
4. antireflux metal rack
Self-inflated metal Esophageal Stent treatment esophagostenosis blocks symptom to alleviation, and improve the quality of living and play certain effect, but the easy concurrent gastroesophageal reflux of postoperative (GORD).Principle with reference to Cardiac valve prosthesis, load onto the antireflux valve in covered stnet far-end inboard, calculate through precision, its length guarantees to open to the stomach side when swallowing, chyme is passed through smoothly, the antireflux valve is blocked the gastric regurgitation of food because pressure dependence retracts in the support, when taking food once more, the antireflux valve is opened to gastric again, and therefore this antireflux valve plays the effect of similar one-way cock, also plays the effect of rebuilding cardia when inserting support.
Esophageal Stent plays a supportive role to esophagus after implanting esophagus, the effect that play and open esophagus, recovers patient's swallow, and using clinically has been very extensive.But because Esophageal Stent can only play the mechanical support effect to the esophagus pipe, and can not play any lethal effect to cancerous cell, thereby can only be a kind of palliative treatment method, survival time of patients be also very short.
Based on radiocurable thought, sometimes after support is implanted, also the patient is carried out radiotherapy clinically, by the lethal effect of ray, come the diffusion of anticancer, thereby play therapeutical effect the esophageal carcinoma to cancerous cell.At present, the radiotherapy mode after the Esophageal Stent that uses is clinically implanted mainly contains following two kinds:
1. support is implanted the external radiotherapy in back
Concrete grammar is: adopt 60Co or 8Mv-x line linear accelerator carry out external exposure.Radiation modality is as follows: add back two oblique wild one-tenth angle irradiations with vertical open country, front, and vertical wild wide 6-7cm, oblique wild wide 5-6cm, the upper bound surpasses focus far-end 3cm, and lower bound 4cm in exposure dose 60-70Gy/6-7 week, shines and all uses conventional fractionated irradiation.External exposure is implanted patient's antisecosis, weight increase behind the esophagus at support, is emotionally stable, routine blood test carries out after normal.
2. support is implanted internal radiation radiotherapy in the after-poppet
Concrete grammar is: one way radiotherapy in support is implanted 20 days left and right sides an actor's rendering of an operatic tune.Adopt silicone rubber Three-channel single-sac pipe, three chamber functions are: lumen leads to stomach, and the nasal feeding diet is used; The logical capsule of red lumen is put in the capsule and is penetrated medicinal liquid usefulness; The logical single capsule of white lumen top, topical is used.According to focus length, select the single-sac canel of appropriate length, the nasal cavity inlet pipe, single capsule location records distance according to gastroscope and is foundation, and feasible in case of necessity x line perspective single-sac canel lead ring labelling location is down adjusted.In the capsule 131I administration concentration 40-60mCi, volume 6-18ml, radioactivity liquid capsule was placed 10 days continuously, put during the pipe, from the high nutrition liquid diet of middle lumen five injections every day capacity.
Though more than two kinds of Therapeutic Method can reach radiocurable effect, inconvenient operation, used dosage height, to treat the course of treatment long at every turn, big to patient's influence.
Summary of the invention
The object of the present invention is to provide a kind of novel medical apparatus and instruments----radioactive esophagus rack and preparation method thereof.
Radioactive esophagus rack of the present invention, its manufacture method is carried out successively as follows:
A. coating material preparation: poly-vinyl alcohol solution is prepared liquid by formula ratio, insert heating for dissolving in the water-bath, temperature 80-90 ℃, time 5-10 hour.
Prescription:
Polyvinyl alcohol 80-140g/L
Plasticizer 8-14g/L
Water repellent agent 15-30g/L
Wherein, this plasticizer can be ethylene glycol, glycerol or tributyl phosphate; This water repellent agent can be sodium sulfate, ammonium sulfate or zinc sulfate.
B. 32P mixes with coating material: get suitable activity 32The P-sodium radio-phosphate,P-32 solution adds and to dissolve completely in the poly-vinyl alcohol solution, and Glass rod stirs, heating in water bath, and 80-90 ℃, time 0.5-1.5 hour, stirred once with Glass rod every 10 minutes in the heating process, so that 32Complete and the poly-vinyl alcohol solution mix homogeneously of P-sodium phosphate.
C. brush the radioactivity coating
With what prepare 32The P-poly-vinyl alcohol solution with the even scrubbing brush of hairbrush on the Esophageal Stent surface.Coat on the support 32P activity is by adding in the polyvinyl alcohol 32The activity of P is controlled.The method that also available multilamellar is brushed improves activity, promptly brushes one deck earlier and is added with 32The polyvinyl alcohol film of P brushes the second layer after waiting it half-dried thereon again so that multilamellar.
D. brush protective layer
Apply the last layer polyurethane coating in radioactivity coating outside, to avoid radioactive loss.
E. solidify
The support that is brushed with coating vertically is placed on the glass plate, leaves standstill, at room temperature spontaneous curing.Face coat is through curable behind the diel.The curing of Esophageal Stent also can be taked alternate manner.
Advantage of the present invention is: proposed a kind of new type medical equipment---radioactive esophagus rack and preparation method thereof.This rack making is simple, easy to operate, be easy to protection, cost is low, radionuclide is easy to control in rack surface activity, in conjunction with firm, be evenly distributed.This support can not only play a supportive role to esophagus by support, and can also play therapeutical effect to the esophageal carcinoma to killing and wounding of cancerous cell by lonizing radiation.
Below in conjunction with accompanying drawing narration the present invention
Description of drawings
Fig. 1 is the preparation flow block diagram of radioactive esophagus rack of the present invention.
The specific embodiment
Embodiment 1
A, coating material preparation: its prescription is: polyvinyl alcohol, 120g/L; Ethylene glycol, 14g/L; Sodium sulfate, 24g/L.The aqueous solution of this prescription is placed on heating for dissolving in the water-bath, 85 ℃ of temperature, 5 hours time.Stir with Glass rod in the heating process, make the solution dissolving evenly.
B, 32P mixes with coating material: get suitable activity 32The P-sodium radio-phosphate,P-32 solution adds and to dissolve completely in the poly-vinyl alcohol solution, and Glass rod stirs, heating in water bath, and 80 ℃, 1 hour time, stirred once with Glass rod every 10 minutes in the heating process, so that 32Complete and the poly-vinyl alcohol solution mix homogeneously of P-sodium phosphate.
C, brush the radioactivity coating: with mix homogeneously 32P solution is cooled to room temperature, with hairbrush this solution is all brushed on Esophageal Stent equably.
D, brushing protective layer: after treating radioactivity coating drying, aqueous polyurethane is brushed equably on the polyethylene coating surface with hairbrush.
E, curing: will brush cated Esophageal Stent and vertically be put on the clean glass plate, and place under the room temperature natural drying until rack surface coating full solidification.
Embodiment 2
Operational approach is the same with embodiment 1 with step, just changes the prescription of face coat:
A, coating material preparation: its prescription is: polyvinyl alcohol, 80g/L; Glycerol, 10g/L; Ammonium sulfate, 20g/L.The aqueous solution of this prescription is placed on heating for dissolving in the water-bath, 85 ℃ of temperature, 5 hours time.Stir with Glass rod in the heating process, make the solution dissolving evenly.
Embodiment 3
A, coating material preparation: its prescription is: polyvinyl alcohol, 100g/L; Tributyl phosphate, 12g/L; Zinc sulfate, 30g/L.Add above component in the prescription water yield, in this solution, drip anhydrous alcohol, soluble in water fully until tributyl phosphate.This solution is put into the water-bath heating for dissolving, 90 ℃ of temperature, time 6-8 hour.Stir with Glass rod in the heating process, so that the polyvinyl alcohol dissolving fully.
B, 32P mixes with coating material: get suitable activity 32The P-sodium radio-phosphate,P-32 solution adds and to dissolve completely in the poly-vinyl alcohol solution, and Glass rod stirs, heating in water bath, and 90 ℃, 1 hour time, stirred once with Glass rod every 10 minutes in the heating process, so that 32Complete and the poly-vinyl alcohol solution mix homogeneously of P-sodium phosphate.
C, brush the radioactivity coating: with mix homogeneously 32P solution is cooled to room temperature, with hairbrush this solution is all brushed on Esophageal Stent equably.
D, brushing protective layer: after treating radioactivity coating drying, aqueous polyurethane is brushed equably on the polyethylene coating surface with hairbrush.
E, curing: the Esophageal Stent that will coat coating is enclosed within on the diameter rubber bar suitable with its internal diameter, and rubber bar is connected on the motor stirrer of horizontal positioned, starts motor stirrer, and the slow-speed of revolution is rotated until Esophageal Stent face coat full solidification.

Claims (6)

1. a radioactive esophagus rack is characterized in that being coated with the coating that carrier band has radionuclide at the outer surface of Esophageal Stent, and the prescription of this coating is: polyvinyl alcohol 80-140g/L, plasticizer 8-14g/L, water repellent agent 15-30g/L and suitable activity 32The P-sodium radio-phosphate,P-32 solution.
2. radioactive esophagus rack according to claim 1 is characterized in that this plasticizer is ethylene glycol, glycerol or tributyl phosphate; This water repellent agent is sodium sulfate, ammonium sulfate or zinc sulfate.
3. radioactive esophagus rack according to claim 1 and 2 is characterized in that this coating that has radionuclide also has a polyurethane protective layer outward.
4. the manufacture method of a kind of radioactive esophagus rack according to claim 1, carry out as follows successively:
A. the preparation of coating material
The polyvinyl alcohol of 80-140g/L, the plasticizer of 8-14g/L and the water repellent agent of 15-30g/L are mixed, heated 5-10 hour down at 80-90 ℃;
B. radionuclide and coating material mixes
With suitable activity 32P-sodium radio-phosphate,P-32 solution and coating material mix homogeneously;
C. brush the radioactivity coating
To contain 32The coating material of P-sodium phosphate is coated in the Esophageal Stent surface equably, forms the radioactivity coating;
D. solidify
Coating is cured, makes it to be combined on the support securely.
5. the manufacture method of radioactive esophagus rack according to claim 4 is characterized in that radioactivity coating outside scribbles one deck polyurethane coating in addition.
6. the manufacture method of radioactive esophagus rack according to claim 4 is characterized in that brushing this radioactivity coating of one deck earlier when brushing the radioactivity coating, brushes the second layer or multilamellar more thereon after waiting it half-dried.
CNB021360154A 2002-07-12 2002-07-12 Radioactive esophagus rack and its making process Expired - Fee Related CN100391556C (en)

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Application Number Priority Date Filing Date Title
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CN100391556C true CN100391556C (en) 2008-06-04

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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100502958C (en) * 2005-12-14 2009-06-24 中国科学院上海应用物理研究所 Radiant stand, radiant polyurethane coating material and their production
CN111012555A (en) * 2019-12-03 2020-04-17 刘训伟 Radionuclide-loaded micro-nano coating stent and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6129658A (en) * 1997-12-10 2000-10-10 Varian Associates, Inc. Method and apparatus creating a radioactive layer on a receiving substrate for in vivo implantation
US6152869A (en) * 1997-12-24 2000-11-28 Korea Atomic Research Energy Research Institute Radioactive stent and process for preparation thereof
US6159142A (en) * 1996-12-10 2000-12-12 Inflow Dynamics, Inc. Stent with radioactive coating for treating blood vessels to prevent restenosis
WO2001072371A1 (en) * 2000-03-30 2001-10-04 Minister For Health In His Capacity As The Board Of Royal Perth Hospital Radioactive implement and method of manufacture of same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6159142A (en) * 1996-12-10 2000-12-12 Inflow Dynamics, Inc. Stent with radioactive coating for treating blood vessels to prevent restenosis
US6129658A (en) * 1997-12-10 2000-10-10 Varian Associates, Inc. Method and apparatus creating a radioactive layer on a receiving substrate for in vivo implantation
US6152869A (en) * 1997-12-24 2000-11-28 Korea Atomic Research Energy Research Institute Radioactive stent and process for preparation thereof
WO2001072371A1 (en) * 2000-03-30 2001-10-04 Minister For Health In His Capacity As The Board Of Royal Perth Hospital Radioactive implement and method of manufacture of same

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