CN109954199A - A kind of prostate expansion of ultrasonically controlled-release carries medicine ball bag system and preparation method thereof - Google Patents
A kind of prostate expansion of ultrasonically controlled-release carries medicine ball bag system and preparation method thereof Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title description 12
- 230000000916 dilatatory effect Effects 0.000 claims abstract description 40
- 229940079593 drug Drugs 0.000 claims abstract description 38
- 239000003094 microcapsule Substances 0.000 claims abstract description 25
- 239000000523 sample Substances 0.000 claims abstract description 10
- 210000003708 urethra Anatomy 0.000 claims abstract description 10
- 210000002700 urine Anatomy 0.000 claims abstract description 7
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- 210000000664 rectum Anatomy 0.000 claims abstract description 3
- 238000002601 radiography Methods 0.000 claims abstract 2
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- 229920002647 polyamide Polymers 0.000 claims description 4
- -1 polyethylene Polymers 0.000 claims description 4
- 229920000573 polyethylene Polymers 0.000 claims description 4
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 4
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 4
- 239000004814 polyurethane Substances 0.000 claims description 4
- 238000002604 ultrasonography Methods 0.000 claims description 4
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- 150000003431 steroids Chemical class 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 2
- 108010064470 polyaspartate Proteins 0.000 claims 2
- 229920001223 polyethylene glycol Polymers 0.000 claims 2
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 1
- 229920001661 Chitosan Polymers 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
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- 238000007599 discharging Methods 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
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- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 1
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- 238000000034 method Methods 0.000 abstract description 11
- 206010004446 Benign prostatic hyperplasia Diseases 0.000 abstract description 7
- 239000002775 capsule Substances 0.000 abstract description 5
- 230000008569 process Effects 0.000 abstract description 4
- 230000000638 stimulation Effects 0.000 abstract description 3
- 230000001225 therapeutic effect Effects 0.000 abstract description 3
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- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 20
- 239000011248 coating agent Substances 0.000 description 19
- 238000000576 coating method Methods 0.000 description 19
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 15
- 238000007654 immersion Methods 0.000 description 15
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- 239000007789 gas Substances 0.000 description 11
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- 229910052757 nitrogen Inorganic materials 0.000 description 10
- 201000010099 disease Diseases 0.000 description 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 6
- 238000013019 agitation Methods 0.000 description 5
- 239000007864 aqueous solution Substances 0.000 description 5
- 239000008367 deionised water Substances 0.000 description 5
- 229910021641 deionized water Inorganic materials 0.000 description 5
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- 239000003995 emulsifying agent Substances 0.000 description 5
- 238000005516 engineering process Methods 0.000 description 5
- 238000004108 freeze drying Methods 0.000 description 5
- 238000005468 ion implantation Methods 0.000 description 5
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- 238000005406 washing Methods 0.000 description 5
- 230000008685 targeting Effects 0.000 description 4
- 206010046442 Urethral dilatation Diseases 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 206010020718 hyperplasia Diseases 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- 230000004888 barrier function Effects 0.000 description 2
- 210000004907 gland Anatomy 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
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- 210000001519 tissue Anatomy 0.000 description 2
- 206010000060 Abdominal distension Diseases 0.000 description 1
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- 238000010521 absorption reaction Methods 0.000 description 1
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- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 229960005475 antiinfective agent Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
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- 230000002526 effect on cardiovascular system Effects 0.000 description 1
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- 238000011010 flushing procedure Methods 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Pathology (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Radiology & Medical Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of ultrasonically controlled-releases of ultrasonic guidance merging to carry medicine dilating sacculus system, including foley's tube, dilating sacculus and ultrasonic probe three parts composition.Expansion of balloon catheter is four cavity configurations, and three chambers are full for sacculus, and another chamber is used for drainage of urine.The compliant balloon at both ends is located at bladder and urethral orifice lower end, for fixing dilating sacculus system, reduces displacement and friction bring damage.Carrying medicine ball capsule has the figures such as spiral shape, zigzag, waveform for expanding narrow urethra, surface design, increases specific surface area and then increases drugloading rate.It is realized by partial size difference medicine carrying microcapsule and carries medicine, micro-capsule can be responded by some strength and the ultrasonic stimulation of frequency, be discharged into mucous membrane of urethra and prostate, ankylurethria caused by the reasons such as treatment hyperplasia of prostate.Miniature ultrasonic probe can in vitro or per rectum uses, and real-time radiography accurately identifies ankylurethria position during setting pipe, so that process of expansion is more intuitive accurate.Ultrasonic probe can also real-time control ultrasonic wave intensity, frequency and time, make carry medicine dilating sacculus surface medicine carrying microcapsule in target position release the drug, obtain preferable utilization ratio of drug and therapeutic effect.
Description
Technical field
The invention belongs to medical instruments fields, are related to a kind of targeting dilating sacculus system, and especially a kind of per urethra mirror is set
The load medicine urethral dilatation balloon system that the non-compliance metal two-chamber entered can drain.Such balloon system can be applied to prostate increasing
In the treatment of ankylurethria caused by the reasons such as raw, can dilating urethra urine is drained, and the cause of disease can be treated prevent again
It is secondary narrow, improve the quality of life of patient.
Background technique
With the improvement of living standards, the exacerbation of personal life-time dilatation and aging, more and more the elderlys are subjected to
The puzzlement of disease of old people.Wherein benign hyperplasia of prostate is the common disease of elderly men, and the disease incidence of US adult male is high
Up to 33.7%, China's male's disease incidence has the tendency that rising year after year up to 16%.Some patients can delay forefront by drug
The hyperplasia of gland, but since prostate peplos is harder, the barrier of blood prostate barrier penetration, anti-proliferative drug is not easy to penetrate, and causes to increase
Raw high recurrence rate is spent greatly, and the quality of life of patient receives large effect.For the operative treatment hand of hyperplasia of prostate
Section, traditional transurethral prostatectomy (TURP) death rate clinically is up to 1.3%~3.2%, and with elderly patients
Other diseases, such as diabetes, cardiovascular and cerebrovascular disease, obstructive lung disease, the risk for excision of performing the operation are higher.Modus operandi amount of bleeding
Greatly, patient's convalescence is long, and wound area is larger, and therapeutic effect is unsatisfactory.Minimally invasive or noninvasive interventional therapy gives old forefront
Gland hyperplasia patient provides new selection.
But current interventional therapy still remains problems.The merging of dilating sacculus relies on doctor to refer to inspection substantially,
Position inaccurate, patient compliance are poor.The compliance of hyperplasia of prostate and balloon material makes the incidence of restenosis occupy height not
Under.
Patent 201210325231.0 discloses a kind of targeting expansion forming foley's tube, which inflates in affected part
Forming, a chamber is for drainage or conveying body fluids or gas, and a chamber is for full targeting lumen distention sacculus, and a chamber is for flushing urine
Road.But such dilating sacculus volume is larger, it has not been convenient to be placed in, and material is softer, hyperplasia recurrence is likely to cause urethra again
It is narrow.201711093486 .8 of patent discloses a kind of medical dilating sacculus, and when unaerated is in rectangular sheet structure, and can
It folds, easily enters pathological lumen.But foley's tube has a single function, and cannot carry medicine and drainage of urine, using with therapeutic effect not
It is ideal.
Summary of the invention
In order to solve the above problem, the present invention provides a kind of better hyperplasia of prostates, and the solution of ankylurethria to be caused to be done
Method.
Technical solution used by the present invention solves the above problems is: ultrasonically controlled-release carries medicine dilating sacculus system, including ball
Capsule dilating catheter, dilating sacculus and ultrasonic probe three parts composition.
Wherein in the distribution of dilating catheter both ends, there are two sacculus, by materials systems such as the silica gel of good biocompatibility, polyurethane
At, for dilating sacculus system positioning and prevent from falling off.Upper end sacculus is placed in bladder and fills, and prevents dilating sacculus system de-
It falls.Lower end sacculus is placed in below prostate and fills, and prevents dilating sacculus system uplink from damaging bladder, and reduce bacterium uplink sense
Dye.
The load medicine ball capsule of dilating sacculus system is by polyethylene (PE), polyethylene terephthalate (PET), polyamide
(PA), the materials such as nylon elastomer (Pebax), polyurethane (PU) are made, and provide good expansion support force, prevent urethra again
It is secondary narrow.Non-compliance, which carries the design of medicine balloon surface, the textures such as spiral shape, waveform, zigzag, to increase surface area, improves
Drugloading rate.Non-compliance carries the micro-capsule that medicine ball capsule area load has ultrasound to respond, package anti-proliferative drug inside micro-capsule, antitumor
Drug, steroid medicine, hormonal medicaments, anti-inflammation drugs, anti-infectives etc..In the ultrasonic stimulation of some strength and frequency
Under, micro capsules break discharges the drug of its package to mucous membrane of urethra, and is diffused into prostata tissue, reaches topical anti-inflammatory, eliminates water
The purpose of swollen and treatment hyperplasia of prostate, lesion, meet clinical various needs, improves efficiency and effect that drug reaches lesion
Fruit.
Expansion of balloon catheter of the present invention is four cavity configurations, and three chambers are respectively used to fill three dilating sacculus, separately
One chamber is used for drainage of urine, places dilator balloon system in urethra convenient for medium-term and long-term, obtain better urethral dilatation and
The effect for inhibiting hyperplasia of prostate, improves the quality of life of patient.
Ultrasonic probe of the present invention can carry out ultrasonic contrast before merging carries medicine dilating sacculus, determine ankylurethria
Position.It is placed in foley's tube through ultrasonic guidance, so that merging process is more accurate, to reach best expansion and drug release effect.
It is even more important, the medicinal balloon of ultrasonically controlled-release provided by the invention, make the position of drug release process, the time and
Burst size is all controllable, ensure that the safety and high efficiency of drug absorption.
The beneficial effects of the present invention are as follows:
1. three balloon structures are convenient for the positioning and fixation of dilating sacculus system, prevent from falling off and shift, reduces foley's tube and urine
The friction and damage in road.
2. ultrasound guidance is placed in dilating sacculus system, the accurate dilating sacculus that is placed in obtains more in ankylurethria position
Good urethral dilatation and targeting drug release effect.
3. being directly diffused into prostate using the medicine carrying microcapsule packaging medicine target administration of balloon surface, reducing drug
Loss, improve the utilization rate of drug.
4. carrying medicine ball capsule to tissue diffusion and breakdown releases drug, this passes through control ultrasound in the process under ultrasonication
Supersonic frequency, intensity and time of probe etc., the Drug controlled release amount that can be quantified, and carried out according to the concrete condition of patient
Adjustment in real time, guarantees the safety and validity of therapeutic process.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of the load medicine dilating sacculus system of ultrasonically controlled-release.1 is compliant balloon, is put in bladder
Prevent foley's tube from falling off.2, to carry medicine dilating sacculus, expand ankylurethria position, surface has medicine carrying microcapsule.3
It for lower end sacculus, is placed in below prostate, prevents foley's tube uplink from shifting.
Fig. 2 is that the medicine carrying microcapsule of balloon surface under ultrasonic stimulation spreads and ruptures drug release schematic diagram
Fig. 3 is that the load medicine dilating sacculus system of ultrasonically controlled-release uses schematic diagram.Wherein, 1 is rectum, and 2 be bladder, and 3 be prostate,
4 pop one's head in for transrectal ul-trasonography, and 5 are placed in bladder for upper end sacculus, and 6 is carry medicine dilating sacculus, and 7 be lower end sacculus, and 8 are
Foley's tube.
Specific embodiment
Specific embodiments of the present invention are described in detail below, but embodiments of the present invention are not limited thereto.
Specific embodiment one
One, the surface of common sacculus is modified
1. using the jagged protrusion of design in 10.0*20 model (diameter 10.0mm length 20mm) common sacculus molding die,
Tooth width is 0.5mm, length 18mm, and non-compliance is made and carries mold needed for medicine dilating sacculus shapes.
2. there is the sacculus of nonplanar graph according to conventional steps production using nylon raw material and be welded in foley's tube
On.
3. the sacculus section in foley's tube carries out plasma immersion processing, promote the adherency of medication coat.Specific steps are as follows:
It places a catheter in plasma immersion and ion implantation device, after vacuumizing, leads to nitrogen, 0.05 ~ 50 pa of gas pressure；Radio frequency is put
200 ~ 1200W of electrical power；Pulsed high voltage generator amplitude 1KV ~ 100KV of load, 50 ~ 40000 hertz of frequency or AC power source
10-20 megahertzs, duty ratio 3% ~ 80%；Heat 50 ~ 200 DEG C of 0.1 ~ 5 hour processing times.
Two, the preparation of drug-carried coat material
1. preparing drug bearing microsphere using fast film emulsifying technology
By a certain amount of raw material: polylactic acid (PLA), poly lactic-co-glycolic acid (PLGA) or polylactic acid-polyglycol (PELA) and
α receptor resist is dissolved in methylene chloride as oily phase.Polyvinyl alcohol (PVA) aqueous solution is as water phase, emulsifying (24000
R/min, 2 min) preparation oil/water (O/W) pre-emulsion, pre-emulsion is poured into fast film emulsifier unit, with certain nitrogen
Pressure presses through the fenestra that aperture is 2 μm repeatedly, and by gained lotion, magnetic agitation volatilization removal organic solvent consolidates it at normal temperature
It is melted into medicine carrying microcapsule, with deionized water centrifuge washing 3 times, finished product is made in freeze-drying.
2. the medicine carrying microcapsule for being 2 μm by the aperture as made from the above method is distributed in water soluble dispersing agent and forms load
Medicine coating material.
Three, the coating of drug-carried coat
1. by the sacculus of plasma immersion treated foley's tube with nominal pressure it is full after, be soaked in institute as above at room temperature
State 20 ~ 60min in medicine coating material；Or by above-mentioned medicine coating material according to 1mm2The effective medicine of 0.1 ~ 50ug of sacculus area
The dosage of object is sprayed at balloon portion surface；
2. being dried in vacuo 30min controlled at 50 ~ 80 DEG C；
3. excluding the gas in sacculus, roll film is carried out.
Four, three balloon system
1. using 10.0*10 model (diameter 10.0mm length 10mm) common sacculus molding die by silica gel raw material according to normal
It advises step and makes compliant balloon.
2. two compliant balloons are respectively welded on foley's tube according to conventional steps.
3. a pair sacculus is dried, tabletting, roll film, sterilizing, the present invention is made.
Specific embodiment two
One, the surface of common sacculus is modified
4. using the jagged protrusion of design in 10.0*20 model (diameter 10.0mm length 20mm) common sacculus molding die,
Tooth width is 0.5mm, length 18mm, and non-compliance is made and carries mold needed for medicine dilating sacculus shapes.
5. there is the sacculus of nonplanar graph according to conventional steps production using nylon raw material and be welded in foley's tube
On.
6. the sacculus section in foley's tube carries out plasma immersion processing, promote the adherency of medication coat.Specific steps are as follows:
It places a catheter in plasma immersion and ion implantation device, after vacuumizing, leads to nitrogen, 0.05 ~ 50 pa of gas pressure；Radio frequency is put
200 ~ 1200W of electrical power；Pulsed high voltage generator amplitude 1KV ~ 100KV of load, 50 ~ 40000 hertz of frequency or AC power source
10-20 megahertzs, duty ratio 3% ~ 80%；Heat 50 ~ 200 DEG C of 0.1 ~ 5 hour processing times.
Two, the preparation of drug-carried coat material
1. preparing drug bearing microsphere using fast film emulsifying technology
By a certain amount of raw material: polylactic acid (PLA), poly lactic-co-glycolic acid (PLGA) or polylactic acid-polyglycol (PELA) and
α receptor resist is dissolved in methylene chloride as oily phase.Polyvinyl alcohol (PVA) aqueous solution is as water phase, emulsifying (24000
R/min, 2 min) preparation oil/water (O/W) pre-emulsion, pre-emulsion is poured into fast film emulsifier unit, with certain nitrogen
Pressure presses through the fenestra that aperture is 5 μm repeatedly, and by gained lotion, magnetic agitation volatilization removal organic solvent consolidates it at normal temperature
It is melted into medicine carrying microcapsule, with deionized water centrifuge washing 3 times, finished product is made in freeze-drying.
3. the medicine carrying microcapsule for being 5 μm by the aperture as made from the above method is distributed in water soluble dispersing agent and forms load
Medicine coating material.
Three, the coating of drug-carried coat
1. by the sacculus of plasma immersion treated foley's tube with nominal pressure it is full after, be soaked in institute as above at room temperature
State 20 ~ 60min in medicine coating material；Or by above-mentioned medicine coating material according to 1mm2The effective medicine of 0.1 ~ 50ug of sacculus area
The dosage of object is sprayed at balloon portion surface；
2. being dried in vacuo 30min controlled at 50 ~ 80 DEG C；
3. excluding the gas in sacculus, roll film is carried out.
Four, three balloon system
1. using 10.0*10 model (diameter 10.0mm length 10mm) common sacculus molding die by silica gel raw material according to normal
It advises step and makes compliant balloon.
2. two compliant balloons are respectively welded on foley's tube according to conventional steps.
3. a pair sacculus is dried, tabletting, roll film, sterilizing, the present invention is made.
Specific embodiment three
One, the surface of common sacculus is modified
7. using the jagged protrusion of design in 10.0*20 model (diameter 10.0mm length 20mm) common sacculus molding die,
Tooth width is 0.5mm, length 18mm, and non-compliance is made and carries mold needed for medicine dilating sacculus shapes.
8. there is the sacculus of nonplanar graph according to conventional steps production using nylon raw material and be welded in foley's tube
On.
9. the sacculus section in foley's tube carries out plasma immersion processing, promote the adherency of medication coat.Specific steps are as follows:
It places a catheter in plasma immersion and ion implantation device, after vacuumizing, leads to nitrogen, 0.05 ~ 50 pa of gas pressure；Radio frequency is put
200 ~ 1200W of electrical power；Pulsed high voltage generator amplitude 1KV ~ 100KV of load, 50 ~ 40000 hertz of frequency or AC power source
10-20 megahertzs, duty ratio 3% ~ 80%；Heat 50 ~ 200 DEG C of 0.1 ~ 5 hour processing times.
Two, the preparation of drug-carried coat material
1. preparing drug bearing microsphere using fast film emulsifying technology
By a certain amount of raw material: polylactic acid (PLA), poly lactic-co-glycolic acid (PLGA) or polylactic acid-polyglycol (PELA) and
α receptor resist is dissolved in methylene chloride as oily phase.Polyvinyl alcohol (PVA) aqueous solution is as water phase, emulsifying (24000
R/min, 2 min) preparation oil/water (O/W) pre-emulsion, pre-emulsion is poured into fast film emulsifier unit, with certain nitrogen
Pressure presses through the fenestra that aperture is 10 μm repeatedly, and by gained lotion, magnetic agitation volatilization removal organic solvent consolidates it at normal temperature
It is melted into medicine carrying microcapsule, with deionized water centrifuge washing 3 times, finished product is made in freeze-drying.
4. the medicine carrying microcapsule for being 10 μm by the aperture as made from the above method, is distributed in water soluble dispersing agent and is formed
Drug-carried coat material.
Three, the coating of drug-carried coat
1. by the sacculus of plasma immersion treated foley's tube with nominal pressure it is full after, be soaked in institute as above at room temperature
State 20 ~ 60min in medicine coating material；Or by above-mentioned medicine coating material according to 1mm2The effective medicine of 0.1 ~ 50ug of sacculus area
The dosage of object is sprayed at balloon portion surface；
2. being dried in vacuo 30min controlled at 50 ~ 80 DEG C；
3. excluding the gas in sacculus, roll film is carried out.
Four, three balloon system
1. using 10.0*10 model (diameter 10.0mm length 10mm) common sacculus molding die by silica gel raw material according to normal
It advises step and makes compliant balloon.
2. two compliant balloons are respectively welded on foley's tube according to conventional steps.
3. a pair sacculus is dried, tabletting, roll film, sterilizing, the present invention is made.
Specific embodiment four
One, the surface of common sacculus is modified
10. the use of design diameter in 10.0*20 model (diameter 10.0mm length 20mm) common sacculus molding die being 0
.5mm, the required molding die of the present invention is made in the strip protrusion of length 18mm, spiral extension.
It is led 11. there is the sacculus of nonplanar graph and be welded in sacculus according to conventional steps production using nylon raw material
Guan Shang.
12. the sacculus section in foley's tube carries out plasma immersion processing, promote the adherency of medication coat.Specific steps
Are as follows: it places a catheter in plasma immersion and ion implantation device, after vacuumizing, leads to nitrogen, 0.05 ~ 50 pa of gas pressure；It penetrates
200 ~ 1200W of frequency discharge power；Pulsed high voltage generator amplitude 1KV ~ 100KV of load, 50 ~ 40000 hertz of frequency or exchange
10-20 megahertzs of power supply, duty ratio 3% ~ 80%；Heat 50 ~ 200 DEG C of 0.1 ~ 5 hour processing times.
Two, the preparation of drug-carried coat material
1. preparing drug bearing microsphere using fast film emulsifying technology
By a certain amount of raw material: polylactic acid (PLA), poly lactic-co-glycolic acid (PLGA) or polylactic acid-polyglycol (PELA) and
α receptor resist is dissolved in methylene chloride as oily phase.Polyvinyl alcohol (PVA) aqueous solution is as water phase, emulsifying (24000
R/min, 2 min) preparation oil/water (O/W) pre-emulsion, pre-emulsion is poured into fast film emulsifier unit, with certain nitrogen
Pressure presses through the fenestra that aperture is 2 μm repeatedly, and by gained lotion, magnetic agitation volatilization removal organic solvent consolidates it at normal temperature
It is melted into medicine carrying microcapsule, with deionized water centrifuge washing 3 times, finished product is made in freeze-drying.
5. the medicine carrying microcapsule for being 2 μm by the aperture as made from the above method is distributed in water soluble dispersing agent and forms load
Medicine coating material.
Three, the coating of drug-carried coat
1. by the sacculus of plasma immersion treated foley's tube with nominal pressure it is full after, be soaked in institute as above at room temperature
State 20 ~ 60min in medicine coating material；Or by above-mentioned medicine coating material according to 1mm2The effective medicine of 0.1 ~ 50ug of sacculus area
The dosage of object is sprayed at balloon portion surface；
2. being dried in vacuo 30min controlled at 50 ~ 80 DEG C；
3. excluding the gas in sacculus, roll film is carried out.
Four, three balloon system
1. using 10.0*10 model (diameter 10.0mm length 10mm) common sacculus molding die by silica gel raw material according to normal
It advises step and makes compliant balloon.
2. two compliant balloons are respectively welded on foley's tube according to conventional steps.
3. a pair sacculus is dried, tabletting, roll film, sterilizing, the present invention is made.
Specific embodiment five
One, the surface of common sacculus is modified
13. jagged prominent using design in 10.0*20 model (diameter 10.0mm length 20mm) common sacculus molding die
It rises, tooth width 0.5mm, length 18mm, non-compliance is made and carries mold needed for medicine dilating sacculus shapes.
It is led 14. there is the sacculus of nonplanar graph and be welded in sacculus according to conventional steps production using nylon raw material
Guan Shang.
15. the sacculus section in foley's tube carries out plasma immersion processing, promote the adherency of medication coat.Specific steps
Are as follows: it places a catheter in plasma immersion and ion implantation device, after vacuumizing, leads to nitrogen, 0.05 ~ 50 pa of gas pressure；It penetrates
200 ~ 1200W of frequency discharge power；Pulsed high voltage generator amplitude 1KV ~ 100KV of load, 50 ~ 40000 hertz of frequency or exchange
10-20 megahertzs of power supply, duty ratio 3% ~ 80%；Heat 50 ~ 200 DEG C of 0.1 ~ 5 hour processing times.
Two, the preparation of drug-carried coat material
1. preparing drug bearing microsphere using fast film emulsifying technology
By a certain amount of raw material: polylactic acid (PLA), poly lactic-co-glycolic acid (PLGA) or polylactic acid-polyglycol (PELA) and
Estrogenic is dissolved in methylene chloride as oily phase.Polyvinyl alcohol (PVA) aqueous solution is as water phase, emulsifying (24000
R/min, 2 min) preparation oil/water (O/W) pre-emulsion, pre-emulsion is poured into fast film emulsifier unit, with certain nitrogen
Pressure presses through the fenestra that aperture is 2 μm repeatedly, and by gained lotion, magnetic agitation volatilization removal organic solvent consolidates it at normal temperature
It is melted into medicine carrying microcapsule, with deionized water centrifuge washing 3 times, finished product is made in freeze-drying.
6. the medicine carrying microcapsule for being 2 μm by the aperture as made from the above method is distributed in water soluble dispersing agent and forms load
Medicine coating material.
Three, the coating of drug-carried coat
1. by the sacculus of plasma immersion treated foley's tube with nominal pressure it is full after, be soaked in institute as above at room temperature
State 20 ~ 60min in medicine coating material；Or by above-mentioned medicine coating material according to 1mm2The effective medicine of 0.1 ~ 50ug of sacculus area
The dosage of object is sprayed at balloon portion surface；
2. being dried in vacuo 30min controlled at 50 ~ 80 DEG C；
3. excluding the gas in sacculus, roll film is carried out.
Four, three balloon system
1. using 10.0*10 model (diameter 10.0mm length 10mm) common sacculus molding die by silica gel raw material according to normal
It advises step and makes compliant balloon.
2. two compliant balloons are respectively welded on foley's tube according to conventional steps.
3. a pair sacculus is dried, tabletting, roll film, sterilizing, the present invention is made.
Claims (13)
1. a kind of target drug-carrying dilating sacculus system of the ultrasonically controlled-release of ultrasonic guidance merging, including foley's tube, dilating sacculus
And ultrasonic probe.
2. expansion of balloon catheter as described in claim 1, it is characterised in that but three sacculus of institute's band are not limited to, upper end sacculus is set
In the fixation in bladder, for balloon system；Middle part sacculus expands narrow urethra after there is non-compliance, pressurization to fill；Under
End sacculus is placed in prostate lower position, fixes and prevent bacterium uplink from infecting for balloon system.
3. expansion of balloon catheter as described in claim 1, it is characterised in that but it is not limited to that there are four chambers, three chambers are for filling
Three sacculus, a chamber are used for drainage of urine.
4. as claimed in claim 3 carry medicine dilating sacculus, selected from polyethylene (PE), polyethylene terephthalate (PET),
Any one or a few material in the materials such as polyamide (PA), nylon elastomer (Pebax), polyurethane (PU) is made, can be with
Expand narrow urethra.
5. carrying medicine dilating sacculus as claimed in claim 3, it is characterised in that surface is covered with the medicine carrying microcapsule of ultrasound response, according to
The drug for discharging its package of ultrasonic intensity, frequency and time quantification.
6. carrying medicine dilating sacculus surface as claimed in claim 3 has medicine carrying microcapsule, it is characterised in that microcapsule granule partial size is not
Together.
7. carrying medicine dilating sacculus surface medicine carrying microcapsule as claimed in claim 3, diameter is that 2 ~ 10 μm of medicine carrying microcapsule can expand
It is scattered in the mucosal tissue of surrounding and releases the drug.
8. carrying medicine dilating sacculus surface medicine carrying microcapsule as claimed in claim 6, it is characterised in that using polylactic acid (PLA), gather
Poly lactic coglycolic acid (PLGA), sodium alginate, polyethylene glycol (PEG), polyglycolide (PGA), gathers in oneself chitosan
Ester (PCL), poly-aspartate (PASP), sodium carboxymethylcellulose (CMC), hydroxypropyl methyl cellulose (INN), polyvinyl alcohol
(PVA), one of polyethers or multiple material are made.The performance parameter requirement of degradable high polymer material are as follows: viscosity 0.1-0.5
Dl/g, weight average molecular weight 20000-100000.
9. contained drug as claimed in claim 5, it is characterised in that but it is not limited to anti-proliferative drug, anti-inflammation drugs, anti-infective
One or more combinations such as drug, anti-tumor drug, steroid medicine, hormonal medicaments.
10. top and bottom dilating sacculus as claimed in claim 2 in the materials such as silica gel, polyurethane any one or
Two kinds of materials are made.
11. ultrasonic probe as described in claim 1, it is characterised in that per rectum or external use, in merging dilating sacculus system
Radiography is carried out before system and determines ankylurethria position, and ultrasonic guidance determines that load medicine dilating sacculus reaches narrow location and filled when setting pipe
It is full of, discharges the contained drug of balloon surface after sacculus is full.
12. ultrasonic probe as described in claim 1, it is characterised in that can with the intensity of real-time control ultrasonic wave, frequency and when
Between.
13. ultrasonic probe as described in claim 1, it is characterised in that but being not limited to frequency of use is 1 ~ 9 MHz, uses power
For 1 ~ 10 W.
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| CN201910379974.8A CN109954199A (en) | 2019-05-08 | 2019-05-08 | A kind of prostate expansion of ultrasonically controlled-release carries medicine ball bag system and preparation method thereof |
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|---|---|---|---|
| CN201910379974.8A CN109954199A (en) | 2019-05-08 | 2019-05-08 | A kind of prostate expansion of ultrasonically controlled-release carries medicine ball bag system and preparation method thereof |
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|---|---|---|---|
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| CN114098898A (en) * | 2021-11-04 | 2022-03-01 | 杭州天路医疗器械有限公司 | Impact waveguide tube of non-airtight saccule and directional medicine feeding method thereof |
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| CN114733048A (en) * | 2022-04-11 | 2022-07-12 | 重庆市人民医院 | Transurethral prostate treatment device |
| CN115281930A (en) * | 2022-06-14 | 2022-11-04 | 温州医科大学附属眼视光医院 | Implant for supporting and expanding Schlemm's canal, implant device and method |
| WO2023169036A1 (en) * | 2022-03-08 | 2023-09-14 | 吉林大学 | Ultrasonic control device and ultrasonic control testing system |
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Address after: 251100 baiduoan biomedical science and Technology Park, No.1, Keji Road, high tech Zone, Qihe County, Dezhou City, Shandong Province Applicant after: Shandong baiduoan Medical Equipment Co.,Ltd. Address before: 251100 baiduoan biomedical science and Technology Park, No.1, Keji Road, high tech Zone, Qihe County, Dezhou City, Shandong Province Applicant before: Shandong Branden Medical Device Co.,Ltd. |
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Application publication date: 20190702 |