CN106821564A - A kind of dual balloon catheter support - Google Patents
A kind of dual balloon catheter support Download PDFInfo
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- CN106821564A CN106821564A CN201611245077.0A CN201611245077A CN106821564A CN 106821564 A CN106821564 A CN 106821564A CN 201611245077 A CN201611245077 A CN 201611245077A CN 106821564 A CN106821564 A CN 106821564A
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- balloon catheter
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- sacculus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/02—Methods for coating medical devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/06—Coatings containing a mixture of two or more compounds
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
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- Optics & Photonics (AREA)
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Abstract
The invention discloses a kind of dual balloon catheter support, it is made up of positioning sacculus and cylinder balloon, wherein cylinder balloon is double-layered balloon, material of its internal layer sacculus from bearing capacity more than 0.5MPa, the material of outer layer sacculus is the one kind in soft polyurethane, latex or silica gel, the surface of cylinder balloon is equipped with support, stent surface coated hydrophilic coating material.The present invention places support for cavity, is particularly suited for Urology Surgery and support is placed in urethra, is supported as dysuria patient temporary, substitutes catheter.
Description
Technical field
The invention belongs to biomaterial for medical purpose and technical field, and in particular to double sacculus and its urethra rack of support.
Background technology
Orifice bracket is divided into permanent stents and temporary stent according to patient profiles' difference, and temporary stent is in the urinary tract
In play a supportive role rather than embedded urethral wall, be divided into metallic support and absorbable biological degradation type support, be to develop in recent years
The temporary stent for getting up, it is made up of high molecular glycolic acid polymer (PGA) or lactic acid polymer (PLA).Have
The features such as histocompatbility is good, inflammatory reaction is small, infection rate occurs low, surface in the absence of crystallizing, need not take out or replace.But
Placed using operation more than the method that support is placed, the surface of a wound is big, and patient recovery times are more long, the dual balloon catheter that the present invention is used,
The effect of sacculus is positioned due to early stage, noninvasive placement can be realized substantially, greatly reduce the operation pain of patient, especially urinated
The placement of road support.
Urethra rack is clinically usually used in the patient of hyperplasia of prostate, and substantial amounts of clinical report shows the recent of stent in the treatment
Curative effect is definite, but its therapeutic effect has a declining tendency over time, and also some problems await our solutions
Certainly：
（1）Hyperplasia of prostate is a kind of benign progressive disease, is increased with the increase at age, and just having when its continuation increases can
The scope that support is supported can be exceeded；
（2）The hyperplasia of different degrees of granulation tissue and epithelium is had in stenter to implant after-frame；
（3）Idicatio and contraindication are how preferably grasped, the support of appropriate size is selected and is placed it on suitable position.
Hyperplasia of prostate mainly causes what ankylurethria triggered to the injury that patient causes by the body of gland of hyperplasia, hyperplasia
Body of gland promotes posterior urethral stricture, bending elongated, bladder bottom is raised initiation urethremphraxis, urination expense occurs so as to cause patient
Power, urination time extension, residual urine becomes and the obstruction such as increases.And endo-urethral stent be one kind temporarily or permanently treat urethra
The treatment method of obstruction, common endo-urethral stent has helical mount, polyurethane support, Bioabsorbable branch
Frame, metal net support and thermal sensitivity support etc..Due to there are following 5 kinds of situations after metallic support implantation：A. postoperative blood clot
Obstruction；B. the patient of original chronic urinary retention, in preoperative long-term band urinary catheter, detrusor urinae of bladder fibrosis；C. prostate-urethra is near
End is not covered by support；D. granulation tissue or epithelium hyperplasia in frame, cause stent stenosis；E. prostata tissue continues to increase
Greatly, more than support two ends, support etc. Bioabsorbable support is blocked：The degradable branch being made of the PLA of pressurization
Frame, tissue reaction is light, can be completely absorbed in 12-14 month, and the short-term effect of endo-urethral stent treatment hyperplasia of prostate is
Preferably, but how its final effect still has to be seen, but for should not row transurethral prostatectomy hyperplasia of prostate
Patient can yet be regarded as a kind of effective method.
The material that high pressure balloon material is applied to high pressure sacculus earliest is polyvinyl chloride（PVC）.Relative to high pressure now
For sacculus, they are pressure-resistant with low with respect to heavy wall.The eighties in early days, cross-linked ethylene also begin to application.At the same time gather to benzene
Naphthalate (PET) is also applied to high pressure sacculus.This two kinds of materials instead of PVC in sizable program.80
Late period in age, nylon also begins to use.Polyurethane sacculus is then applied in the early stage nineties.Nylon, its intensity is not so good as
PET, also there is a compliance not as PE, but as compensation is that it is softer than PET, but relative thin-walled is excellent with intensity
Point.Today, most high pressure sacculus was manufactured with PET or nylon.PET is advantageous with pressure-resistant direction in intensity, and nylon phase
To softer.It is typically resistance to be pressed in 2 ~ 20 atmospheric pressure according to the specific size of sacculus for the sacculus of support（30
To 300PSI）, the diameter of sacculus is bigger, and it is lower that its is pressure-resistant.One great advantage of PEF sacculus be PET have one it is unusual
Function, it can be with forming superthin wall thickness, the sacculus with suitable arcuate shape.Because PET sacculus possesses ultra-thin wall thickness, scope
From 5 to 50 μm, (0.0002 inch to 0.002 inch) can manufacture the sacculus of Superminiature.High pressure PET sacculus can be produced
Diameter can be from 0.5mm to 50mm or wider, can have various active lengths, but keep very thin wall thickness simultaneously.They
May be tailored to along sacculus reducing, two ends cone angle can be from 1 to 90 degree.Additional advantage be possess splendid heat transfer characteristic with
Light transmittance.This causes that PET sacculus is applied to ND:YAG laser or other laser, ultrasound, microwave energy application.
Nylon high pressure sacculus comes softer than PET sacculus, and certain intensity is also a bit weaker.Therefore for specified
, it is necessary to thicker wall thickness for burst pressure.This often means that the profile of PA sacculus more slightly larger than PET sacculus one
A bit, it is a bit weaker by passing through the ability of lesion in vivo.But exactly because material is softer, it becomes to be more prone to fold, because
This is more prone to be withdrawn from pipe sheath or conduit in PCI.
Principal item in nylon is nylon 6 and nylon66 fiber, accounts for absolute leading position, next to that nylon 11, nylon 12, Buddhist nun
Dragon 610, nylon 612, also nylon 1010 in addition, nylon 46, nylon 7, nylon 9, nylon 13, new varieties have nylon 6I, nylon
9T and special nylon MXD 6 (barrier resin) etc., the transformed lines show quantity of nylon are various, such as enhancing nylon, monomer moulding casting nylon
(MC nylon), reaction injection molding (RIM) nylon, aromatic nylon, transparent nylon, high-impact (ultra-toughness) nylon electroplates nylon,
Electroconductive nylon, fire-retardant nylon, nylon and other polymers blend and alloy etc., meet different particular/special requirements, are widely used as gold
The traditional material substitutes such as category, timber, as various structural materials.
Magnesium be body metabolism necessary to element, the content in human body is only second to potassium, sodium, calcium, body constituted about in bone tissue
The half of interior all magnesium.Research thinks that magnesium is the confactor of many enzymes, with stabilized DNA and RNA structures；Magnesium passes through in vivo
Kidney and enteron aisle are maintained at O.7 and 1.05mmol/L between；Magnesium can stimulate new bone growth, and histocompatbility is good.The main of magnesium lacks
Point is low corrosion resistance, and in the physiological environment of pH (7.4-7.6), magnesium has very strong reduction so as in tissue fully healing
Preceding loss mechanical integrity, and produce the hydrogen that body cannot absorb in time.Early stage is applied to the mg-based material implantation in human body
Substantial amounts of gas is produced after in vivo causes the magnesium cannot to be applied to human body, so preparing the magnesium base alloy of controlled degradation, magnesium is degraded
During the hydrogen that produces fall there is very real meaning by tissue fluid metabolism, a few days ago, various degradeds and processing characteristics are different
Magnesium alloy materials also into the focus of research.
Increase the coating of hydrophilic coating, the compliance in balloon-stent placement process can be increased, therefore, in double balls of the invention
The development of hydrophilic coating is increased on the basis of capsule support.
A kind of hydrophilic coating for preparing and can reducing medical device surface friction is described in European patent 0586324A1
Method, except containing binding property polymer, hydrophilic polymeric beyond the region of objective existence, being additionally added a kind of inorganic compound, such as NaCl in hydrophilic coating,
Purpose is to improve coating penetration pressure, but the defect of this coating is that NaCl is difficult to be dissolved in organic solvent, with the shape of suspension
Formula is present in catheter surface, and the conduit of gained seems relatively rough, and visual impression is very poor.
Described in United States Patent (USP) 6221425B1 it is a kind of can be used for the hydrophilic coating of medicine equipment, it is necessary to carry out two it is anti-
Should, one layer of polymerizable monomer solution is applied in catheter surface first, it is polymerized by certain reaction, last layer is then applied again
Hydrophilic polymer, obtains hydrophilic coating after dried process, this means are easier to form some residual monomers for being difficult removal,
Influence the security of conduit.
Chinese invention patent CN100591389C, is the coating by directly carrying out silica gel in the outside of conduit, although specially
Silica gel coating twice is carried out in profit, more common foley's tube is to improve lubrication, but is far from this patent institute
The profit and property that the boiomacromolecule synthesis macromolecule of use is combined by silane coupler are high, while these macromolecules are all
Degradable, even if having part to remain will not also cause unnecessary secondary injury to body.
Chinese invention patent CN1029087123, although used lubricating polymer layer, but be selected by macromolecule
The polyvinylpyrrolidone of different K values, not over the engagement of coupling agent, the membrane stability for being formed is weaker.
Involved a kind of composition of lubricating hydrophilic coating for medical catheter in the A of Chinese invention patent CN 102166377, should
Composition is made up of acetals polymer, hydrophilic polymer and citric acid ester plasticiser, is the painting formed by aldolisation
Layer, easily forms some small molecules, with potential biohazard.
The silane coupler that patent of the present invention is used carries out boiomacromolecule and the high molecular engagement of synthesis, so as to viscous
Border face forms strength chemical bond higher, substantially improves adhesive strength.Increased coating（Lubricating layer）Stability and hold
Long property.Boiomacromolecule polysaccharide such as hyaluronic acid etc. has and clearly lubricates and the effect of preventing adhesion simultaneously.Belong to environmentally friendly
Coating.Particularly a kind of balloon catheter system of super lubrication, can effectively reduce the coefficient of friction of conduit and blood vessel, have strong bullet
Property makes surface more comfortable, more lubricates.
Found by research, the degradable urethra magnesium alloy branch supported using double saccule urinary catheters of present invention design
Frame, can be very good to be positioned at support on accurate position, reach good support effect, solve controlled micturition difficulty
Problem, and the function of sphincter urethrae is not influenceed, interior animal experiment result shows, due to the super lubricant coating of coating, puts
The process of putting does not result in tissue mucous membrane of urethra and the adverse reactions such as granuloma occurs, and clinical value the most real is, due to double
The invention and application of sacculus, solve and put urethra rack and need the problem that could place of performing an operation of being in hospital, and relieve the pain of patient
Hardship, with very useful clinical value.
The content of the invention
The invention discloses a kind of dual balloon catheter support, it is made up of positioning sacculus and cylinder balloon, wherein cylinder balloon
It is made up of double-layered balloon, internal layer balloon material is pressure-bearing material, the material of outer layer sacculus is selected from polyurethane, latex and silica gel
One kind, the surface of the cylinder balloon is equipped with support.
Wherein, the surface coating hydrophilic coating material of the support, the coating material is selected from and can be used for medical catheter profit
The coating macromolecular material of sliding function, specifically comprising the water-soluble high-molecular material of polyhydroxy, carboxyl and amino, such as polyethylene
Alcohol, sodium alginate, cellulose, glucan, β-cyclodextrin and the copolymer by polyethylene glycol and polypropylene glycol, polyethylene glycol system
Row（PEG200、400、600、1000、2000）, it is PVA series, polyoxyethylene material, polyvinylpyrrolidone, shitosan, bright
The modified forms and copolymer hyaluronic acid, fat of glue, collagen, collagen-N- HOSu NHSs and above-mentioned substance
Acid（Carbon chain lengths 2-20, such as ethanedioic acid, propionic acid, succinic acid）, fatty alcohol（Carbon chain lengths 2-20, such as ethylene glycol, propane diols, third
Triol, butanediol）In one or two, its coat weight percentage be less than 10%.
Material of the internal layer sacculus from bearing capacity more than 0.5MPa, selected from kevlar fabric enhancing composite, butyl
Rubber, silicon rubber, polyurethane PU, crosslinked polystyrene, polyethylene terephthalate PET, polytetrafluoroethylene PTFE, polyethylene
One or more mixing in PE, nylon PA, carbon fiber, polycarbonate and polyethylene terephthalate, can hold
The preferred nylon of interior balloon material and its copolymerizing and blending of pressure are material modified, are chosen in particular from nylon 6, nylon66 fiber, nylon 12 one
Plant, preferably nylon 12.
Dual balloon catheter support of the present invention, is equipped with support on cylinder balloon surfacing, support is selected from degradable
One kind in support and non-degradable support.
Dual balloon catheter support, is entered using silane coupler to the synthesis macromolecule of biological macromolecule polysaccharide and good film-forming property
Into coating material, its preparation process is comprised the following steps row crosslinking Treatment：
（1）Silane coupler ethanol is diluted to 1-25% solution, is atomized or is coated in the dual balloon catheter support for fixing support
Surface, dries；
（2）Aqueous high molecular material is dissolved in water, 0.1-25% solution for standby is made into；
（3）Will（1）Surface atomizing has the dual balloon catheter support of silane coupler, is placed on（2）Plant immersion -100 minutes 1 minute
Hour, drying（Temperature 37-80 degree）；
（4）Packaging, sterilizing.
Wherein silane coupler is selected from by monoamine base silane, double amino silanes and a kind of triamido silane or group therein
Close, the addition of silane coupler is 0.1-5.0%, the dissolving medium of silane coupler is ethanol, water and other organic molten
Agent, the reaction time is 0-10 minutes, the lubricant coating of acquisition：Tensile strength is 38-45Mpa；Elongation percentage is 12-16%；Young mould
It is 200-300Mpa to measure；Swellability is 80-100%；Contact angle is 20.49 ° -26.37 °, can meet the jail on foley's tube
Gu attachment, can play a part of to increase lubrication.
Timbering material is stainless steel, titanium alloy, memorial alloy, high purity iron（Purity is more than 99.0%）, high purity magnesium（Purity is big
In 99.0%）, Mg-Fe alloy（Percentage by weight is 1：0.01-10）, Mg-Zn based alloy（Percentage by weight is 1：0.01-1）, magnesium
Calcium alloy（Percentage by weight is 1：0.01-1）, Magnesium-aluminum alloys（Percentage by weight is 1：0.01-0.1）In one kind or two
Plant combination.
Degradable metal material disclosed by the invention, adding ingredient be iron, copper, zinc, cobalt, manganese, chromium, selenium, iodine, nickel, fluorine,
Molybdenum, vanadium, tin, silicon, strontium, boron, rubidium, arsenic, silver, a kind of combination of or many Zhang Yuansus, first magnesium alloy materials its weight percentages of components
For:Iron 0-2.0%, copper 0-2.0%, zinc 0-2.0%, cobalt 0-2.0%, manganese 0-2.0%, chromium 0-2.0%, selenium 0-2.0%, iodine 0-2.0%,
Nickel 0-2.0%, fluorine 0-2.0%, molybdenum 0-2.0%, vanadium 0-2.0%, tin 0-2.0%, silicon 0-2.0%, strontium 0-2.0%, boron 0-2.0%, rubidium 0-
2.0%th, silver 0.1~4%；Including：High purity iron（Purity is more than 99.0%）, high purity magnesium（Purity is more than 99.0%）, Mg-Fe alloy（Weight
Percentage is 1：0.01-10）, Mg-Zn based alloy（Percentage by weight is 1：0.01-1）, magnesium calcium alloy（Percentage by weight is 1：
0.01-1）, Magnesium-aluminum alloys（Percentage by weight is 1：0.01-0.1）In one or two combination.Wherein Mg-Fe alloy（Weight
Amount percentage preferably 1：0.01-0.1）, Mg-Zn based alloy（Percentage by weight preferably 1：0.01-0.1）, such as：Mg-Nd-Zn-
Zr, Mg-Zn-Mn, Mg-Zn-Mn-Se-Cu alloy, Zn contents are 3.5wt%, and Mn contents are 0.5-1.0wt%, Se contents
It is 0.4-1.0wt%, Cu contents are 0.2-0.5wt%, Mg surpluses；Magnesium calcium alloy（Percentage by weight preferably 1：0.01-
0.1）, such as：Mg-Zn-Ca-Fe, Magnesium-aluminum alloys（Percentage by weight is preferably 1：0.01-0.1, such as：Aluminium（Al）：2.0~
3.0wt.%, zinc（Zn）：0.5 ~ 1.0wt.%, manganese（Mn）, Mg surpluses：
Organic solvent of the present invention, selected from toluene, paraxylene, decane, isoamyl acetate, hexane, benzene, dichloromethane,
Chloroform, cyclohexanone, ketone, dimethylformamide, heptane, dimethylamino formamide, tetrahydrofuran, petroleum ether, diformazan are sub-
One or two in sulfone, ethylene glycol terephthalate, preferably tetrahydrofuran, decane, ethanol, acetone, isoamyl acetate, oneself
One or two in alkane, dichloromethane, chloroform, cyclohexanone, dimethylformamide and heptane.
Organic solvent of the present invention, selected from toluene, paraxylene, decane, isoamyl acetate, hexane, benzene, dichloromethane
Alkane, chloroform, cyclohexanone, ketone, dimethylformamide, heptane, dimethylamino formamide, tetrahydrofuran, petroleum ether, diformazan
One or two in sulfoxide, ethylene glycol terephthalate, preferably tetrahydrofuran, chloroform, toluene, paraxylene, second
One kind in isoamyl valerate or hexane.
Dual balloon catheter support water-soluble coating of the present invention：The one kind in polysaccharide and protein is specifically included, is had
Body is selected from polyvinyl alcohol, carrageenan, Arabic gum, guar gum, fibrinogen, starch, sodium alginate, cellulose, poly- hydroxyl
Base alkanoic acid ester, pectic acid, actinic acid, modified and unmodified fibrin and casein, carboxymethyl sulfuric ester, white egg
In vain, Heparan sulfate, heparin, chondroitin sulfate, glucan, β-cyclodextrin and the copolymerization by polyethylene glycol and polypropylene glycol
Thing, polyethylene glycol series（PEG200、400、600、1000、2000）, PVA series, polyoxyethylene material, shitosan, gelatin,
Collagen, the modified forms of collagen-N- HOSu NHSs and above-mentioned substance and copolymer hyaluronic acid, aliphatic acid
（Carbon chain lengths 2-20, such as ethanedioic acid, propionic acid, succinic acid）, fatty alcohol（Carbon chain lengths 2-20, such as ethylene glycol, propane diols, the third three
Alcohol, butanediol）, amino acid（20 kinds of amino acid：Glycine, alanine, valine, leucine, isoleucine, phenylalanine and
Proline, tryptophan, serine, tyrosine, cysteine, methionine, asparagine, glutamine and threonine, asparagus fern ammonia
Acid and glutamic acid, lysine, arginine and histidine）, polypeptide, polyaminoacid, bone growth factor BMP series, promote bone uptake
The such as commercially available Ossotide injection of nutriment or complex bone peptide for injection in one kind, mannitol, water soluble vitamin, fat
Fat race is based on the hydrophilic biomaterial of the hydrophilic biomaterial of peptide, polyester or poe base, the amino-acid ester of incorporation, grape
Sugar, glyceyl, lactate or imidazole radicals side base, vinyl acetate, acrylamide and methacrylate or any its derivative or
Copolymer, or its copolymer micelle, such as triblock copolymer PEO-PPO-PEO, PPO-PEO-PPO, polyvinylpyridine-poly-
Styrene polyvinylpyridine（PVP-PS-PVP）, PS-PVP-PS, PS-PEO-PS, PEO-PS-PEO.In some preferred realities
Apply in scheme, first component includes absorbable material, is that flowable room temperature contains polymerizable functional group.
Dual balloon catheter support of the present invention, including contrast agent, are chosen in particular from zirconium dioxide, barium sulfate and Operand
In one kind, add in the material for preparing dual balloon catheter, it is also possible to addition coating lubriation material in, addition weight
Must be the 1-20% of macromolecular material, the material used by preferably 2-10%, wherein sacculus is addition such as polyvinyl chloride, dry glue（It is raw
Glue）, add developer barium sulfate in silicon rubber and natural emulsion, added in the covering material in preparing urethra rack conventional
Radiography Operand, such as：Cardiografin, iotrolanvist, amidotrizoic acid, iohexol, Iopromide and B-15000
（iopamidol）Deng.
Dual balloon catheter support of the present invention, sterilization method is irradiation, electron beam and other sterilization methods, is used
Journey is secured the stand on the cylinder balloon of double sacculus for said composition, and support is put into bladder, fixed by preposition inflated
Position, then inflates to cylinder balloon, struts support, and after support is put into position, double sacculus lose heart, and take out conduit.
The present invention is used for the dual balloon catheter support Design of urethra, as shown in figure 1, the generally diameter 4-7mm of urethra rack,
3-5cm long, support is processed into the decorative pattern that can be expanded and with support force, and the mode on sacculus can be by branch
Frame pipe itself tension force extruding it is docile and obedient on sacculus, or curling be attached on sacculus, being strutted with the expansion of sacculus and pacified
Position is attached to, is placed in prostate-urethra, make the distal end of urethra rack each away from sphincter urethrae 3-5mm, make the urethra rack can
Dilating urethra does not injure sphincter again.
Brief description of the drawings
Fig. 1：The structural representation of dual balloon catheter support；
Fig. 2：State diagram when urethra rack is strutted in dual balloon catheter support.
Description of reference numerals：
1st, sacculus inflating catheter joint is positioned；2nd, sacculus inflating catheter is positioned；4th, the internal layer sacculus of cylinder balloon；5th, place kick
Capsule；6th, cylinder balloon inflating catheter joint；7th, cylinder balloon inflating catheter；8th, urethra rack；9th, the outer layer sacculus of cylinder balloon.
Specific embodiment
Embodiment one：The urethra rack of double sacculus supports
Double saccule urinary catheters as shown in Figure 1 are made using silica gel material, support pressure or be attached on cylinder balloon, catheter
After being put into urethra, by positioning sacculus inflating catheter joint 1 and positioning sacculus inflating catheter 2 to being inflated in positioning sacculus 5, position
Sacculus 5 is positioned, then by cylinder balloon inflating catheter joint 6 and internal layer ball from cylinder balloon inflating catheter 7 to cylinder balloon
Inflated in capsule 4, the outer layer sacculus 9 of cylinder balloon struts urethra rack 8, be supported on urethra area, two positioning sacculus 5 and columns
The internal layer sacculus 4 of sacculus is withdrawn from after deflating, that is, complete the placement of support.
Preparation process is as follows：
(1) by metal material（Stainless steel）Work out, carve, etch or cut into the decorative pattern of needs（Open source information can be retrieved）, branch
Frame diameter 3mm, 2cm long；
(2) shitosan is made into 2% aqueous solution；
(3) will（1）The metallic support of middle preparation, passes through（2）Dip-coating or even application are made coating and are combined in rack surface repeatedly
Support, the material thickness of coating is 0.01-0.05mm.
The measure of mechanical performance, swellability and contact angle is carried out, as a result such as following table：
Embodiment two：Double saccule urinary catheter overlay film urethra racks
Double saccule urinary catheters as shown in Figure 1 are made using latex material, overlay film urethra rack is installed, its preparation process is as follows：
(1) degradable metal material compiled into engraving, etch or cut into the decorative pattern or lath-shaped of needs（Open source information can be retrieved）,
Stent diameter 3mm, 2cm long；
(2) degradable medical polyurethane material is dissolved in dichloromethane solvent, 0.2-0.3mm is paved on tetrafluoroethene plate
Thick film；
(3) by step（2）The film roll of preparation is in step（1）The metallic support metal material surface of middle preparation, is made overlay film branch
Frame, the silane coupler KH560 ethanol solutions of the concentration of surface spraying 3%；
(4) by step（3）The composite of middle preparation is by dip-coating or spraying hydrophilic coating（The 1%PVA aqueous solution）, soak 5 points
Clock, drying（45-55 degree）, polish, be polished to super lubricating film coated support.
The measure of mechanical performance, swellability and contact angle is carried out, as a result such as following table：
Embodiment 3：Double saccule urinary catheter mixed coating urethra metallic supports
（1）Configure 2% Sodium Hyaluronate（HA）Solution, stirring 12h makes it fully swelling, and normal temperature storage is standby.By polyvinyl pyrrole
Alkanone（K90-PVP）It is 6% to be configured to concentration, is heated under 90 ° of hot baths swelling 4 hours, and hyaluronic acid is pressed with polyvinyl alcohol
HA:PVP=3：1 is mixed, the addition final concentration of 4.0% of silane coupler KH560, is stirred 4 minutes, and vacuum deaerator obtains white
The sticky film liquid of color, clean smooth slide and conduit are immersed in film liquid simultaneously, are taken out after 2 hours, in an oven 70 DEG C of bakings
Dry film forming.
（2）By metal material（Stainless steel）Work out, carve, etch or cut into the decorative pattern of needs（Open source information can be examined
Rope）, stent diameter 3mm, 2cm long；
（3）By step（1）The metallic support of middle preparation, by step（2）Dip-coating or even application are in rack surface, system repeatedly
Into coating compound rest, the material thickness of coating is 0.01-0.05mm.
The measure of mechanical performance, swellability and contact angle is carried out, as a result such as following table：
Embodiment 4：Double saccule urinary catheter urethra rack beasle dog implantation degradation experiment observations
The urethra rack of the double saccule urinary catheters support that will be prepared in embodiment 1,2, uses irradiation sterilization.6 body weight 12KG of selection
The beasle dog of left and right, the urethra that dog is implanted into respectively is observed, every group 3.Postoperative routine observation urination and urethra area
Swelling degree, serology, histotomy observation.Test result indicate that：Support in embodiment 1 starts degraded, 6 weeks after 2 weeks
Degraded is complete；Support in embodiment 2 starts degraded for 4 weeks, and degraded in 8 weeks is complete, and urethra area tissue inflammation reaction is light, organizes phase
Capacitive is fine, with good supporting role.
The above, is only presently preferred embodiments of the present invention, and any formal limitation, Ren Hewei are not done to the present invention
The content of disengaging technical solution of the present invention, any simple modification made to above example according to technical spirit of the invention,
Equivalent variations and modification, belong to the scope of technical solution of the present invention.
Claims (10)
1. a kind of dual balloon catheter support, it is characterised in that be made up of positioning sacculus and cylinder balloon, wherein cylinder balloon is by double
Layer sacculus is made, and the material of internal layer sacculus is pressure-bearing material, and the material of outer layer sacculus is selected from polyurethane, latex and silica gel
Kind, the surface of the cylinder balloon is equipped with support.
2. dual balloon catheter support according to claim 1, it is characterised in that the surface of the support coats hydrophilic painting
Layer material, the coating material is selected from the macromolecular material that can be used for medical catheter coating, specifically comprising polyhydroxy, carboxyl and ammonia
The water-soluble high-molecular material of base, the water-soluble high-molecular material be polyvinyl alcohol, sodium alginate, cellulose, glucan, β-
The copolymer of cyclodextrin, polyethylene glycol and polypropylene glycol, polyethylene glycol series, PVA series, polyoxyethylene material, polyethylene
The modified forms of pyrrolidones, shitosan, gelatin, collagen, collagen-N- HOSu NHSs and above-mentioned substance and
One or more mixing, the coat weight percentage of the coating material in copolymer hyaluronic acid, aliphatic acid, fatty alcohol
Than less than 10%.
3. dual balloon catheter support according to claim 1 and 2, it is characterised in that the internal layer sacculus selects bearing capacity
Material more than 0.5MPa, selected from kevlar fabric enhancing composite, butyl rubber, silicon rubber, polyurethane PU, crosslinking polyphenyl second
Alkene, polyethylene terephthalate PET, polytetrafluoroethylene PTFE, polythene PE, nylon PA, carbon fiber, polycarbonate and poly-
One or more mixing in ethylene glycol terephthalate.
4. dual balloon catheter support according to claim 1 and 2, it is characterised in that the material of the internal layer sacculus is preferred
Nylon and its copolymerizing and blending are material modified, are the one kind in nylon 6, nylon66 fiber, nylon 12.
5. dual balloon catheter support according to claim 1 and 2, it is characterised in that the support is selected from biodegradable stent
With the one kind in non-degradable support.
6. dual balloon catheter support according to claim 2, it is characterised in that the coating material uses silane coupler
Crosslinking Treatment is carried out to the synthesis macromolecule of biological macromolecule polysaccharide and good film-forming property to form, its preparation process includes following step
Suddenly：
（1）Silane coupler ethanol is diluted to 1-25% solution, is atomized or is coated in the dual balloon catheter support for fixing support
Surface, dries；
（2）Aqueous high molecular material is dissolved in water, 0.1-25% solution for standby is made into；
（3）By step（1）Middle surface atomizing has the dual balloon catheter support of silane coupler, is placed on step（2）What is be made into is molten
Dried under immersion 1-100 minutes, temperature 37-80 degree in liquid；
（4）Packaging, sterilizing.
7. dual balloon catheter support according to claim 2, it is characterised in that the coating material uses silane coupler
Crosslinking Treatment is carried out to the synthesis macromolecule of biological macromolecule polysaccharide and good film-forming property to form, the silane coupler is selected from by list
Amino silane, double amino silanes and triamido silane one or more combinations, the addition of the silane coupler therein
It is 0.1-5.0% to measure, and the dissolving medium of the silane coupler is ethanol, water and other organic solvents, and the reaction time is 0-
10 minutes, the tensile strength of the coating material was 38-45Mpa, and elongation percentage is 12-16%, and Young's modulus is 200-300Mpa,
Swellability is 80-100%, and contact angle is 20.49 ° -26.37 °.
8. dual balloon catheter support according to claim 1 and 2, it is characterised in that the material of the support be stainless steel,
In titanium alloy, memorial alloy, high purity iron, high purity magnesium, Mg-Fe alloy, Mg-Zn based alloy, magnesium calcium alloy, Magnesium-aluminum alloys one
Plant or two or more combinations.
9. the dual balloon catheter support according to claim 1 or 6, it is characterised in that also prepare material including making an addition to it
Interior contrast agent, is the one kind in zirconium dioxide, barium sulfate and Operand, and the sterilization method of the contrast agent is irradiation or electronics
Beam.
10. the dual balloon catheter support according to claim 1,2,6 or 7, it is characterised in that can be used for putting for orifice bracket
Put, it is adaptable to esophagus, enteron aisle, biliary tract and urethra, be particularly suited for the placement of urethra rack, be used to substitute operation placement, subtract
Few patient suffering.
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108742959A (en) * | 2018-04-21 | 2018-11-06 | 李皇德 | A kind of blood saccule, balloon-stent drug release device and its medicine release method |
| CN108926738A (en) * | 2018-07-06 | 2018-12-04 | 苏州盖德精细材料有限公司 | A kind of preparation method of the silicon rubber medical dressing of high-efficiency antimicrobial |
| CN109010929A (en) * | 2018-09-23 | 2018-12-18 | 湖南博隽生物医药有限公司 | A kind of Medical urethral catheter |
| CN109096724A (en) * | 2018-06-22 | 2018-12-28 | 宁波帅特龙集团有限公司 | Handle is opened in one kind |
| CN109481740A (en) * | 2019-01-11 | 2019-03-19 | 杭州劲驰医疗器械有限公司 | A kind of preparation and application of biomimetic polymer material |
| CN109908409A (en) * | 2019-04-10 | 2019-06-21 | 深圳市美好创亿医疗科技有限公司 | Silicon stent preparation method and silicon stent |
| CN111035813A (en) * | 2018-10-15 | 2020-04-21 | 复旦大学附属中山医院 | Liquid band-aid type coronary artery membrane stent and manufacturing method thereof |
| CN111839849A (en) * | 2020-07-17 | 2020-10-30 | 易浦润（上海）生物技术有限公司 | Urethral stent and preparation method and application thereof |
| EP3791831A1 (en) * | 2019-09-10 | 2021-03-17 | AIT Austrian Institute of Technology GmbH | Implant for treatment of a hernia |
| CN114349996A (en) * | 2021-12-03 | 2022-04-15 | 广东省科学院健康医学研究所 | Super-smooth material and preparation method and application thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030153899A1 (en) * | 1998-02-04 | 2003-08-14 | Uzi Eshel | Urethral catheter and guide |
| CN101822866A (en) * | 2009-03-02 | 2010-09-08 | 东莞市迪凯精密管材有限公司 | Dual balloon hemangiectasis catheter |
| CN104189963A (en) * | 2014-05-13 | 2014-12-10 | 奚廷斐 | Preparation method of surface coating capable of lowering degradation rate of fully-degradable magnesium alloy vascular stent |
| CN205569125U (en) * | 2015-09-30 | 2016-09-14 | 苏州纳晶医药技术有限公司 | Degradable urethra support composition that two sacculus catheters supported |
| CN106178231A (en) * | 2016-08-03 | 2016-12-07 | 武汉福脉医疗科技有限公司 | Medical double-deck high pressure resistant sacculus and preparation method thereof |
-
2016
- 2016-12-29 CN CN201611245077.0A patent/CN106821564A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030153899A1 (en) * | 1998-02-04 | 2003-08-14 | Uzi Eshel | Urethral catheter and guide |
| CN101822866A (en) * | 2009-03-02 | 2010-09-08 | 东莞市迪凯精密管材有限公司 | Dual balloon hemangiectasis catheter |
| CN104189963A (en) * | 2014-05-13 | 2014-12-10 | 奚廷斐 | Preparation method of surface coating capable of lowering degradation rate of fully-degradable magnesium alloy vascular stent |
| CN205569125U (en) * | 2015-09-30 | 2016-09-14 | 苏州纳晶医药技术有限公司 | Degradable urethra support composition that two sacculus catheters supported |
| CN106178231A (en) * | 2016-08-03 | 2016-12-07 | 武汉福脉医疗科技有限公司 | Medical double-deck high pressure resistant sacculus and preparation method thereof |
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108742959A (en) * | 2018-04-21 | 2018-11-06 | 李皇德 | A kind of blood saccule, balloon-stent drug release device and its medicine release method |
| CN109096724A (en) * | 2018-06-22 | 2018-12-28 | 宁波帅特龙集团有限公司 | Handle is opened in one kind |
| CN108926738A (en) * | 2018-07-06 | 2018-12-04 | 苏州盖德精细材料有限公司 | A kind of preparation method of the silicon rubber medical dressing of high-efficiency antimicrobial |
| CN109010929B (en) * | 2018-09-23 | 2021-08-13 | 湖南博隽生物医药有限公司 | Medical catheter |
| CN109010929A (en) * | 2018-09-23 | 2018-12-18 | 湖南博隽生物医药有限公司 | A kind of Medical urethral catheter |
| CN111035813A (en) * | 2018-10-15 | 2020-04-21 | 复旦大学附属中山医院 | Liquid band-aid type coronary artery membrane stent and manufacturing method thereof |
| CN111035813B (en) * | 2018-10-15 | 2022-02-18 | 复旦大学附属中山医院 | Liquid band-aid type coronary artery membrane stent and manufacturing method thereof |
| CN109481740A (en) * | 2019-01-11 | 2019-03-19 | 杭州劲驰医疗器械有限公司 | A kind of preparation and application of biomimetic polymer material |
| CN109481740B (en) * | 2019-01-11 | 2022-09-20 | 杭州劲驰医疗器械有限公司 | Preparation and application of bionic high polymer material |
| CN109908409A (en) * | 2019-04-10 | 2019-06-21 | 深圳市美好创亿医疗科技有限公司 | Silicon stent preparation method and silicon stent |
| EP3791831A1 (en) * | 2019-09-10 | 2021-03-17 | AIT Austrian Institute of Technology GmbH | Implant for treatment of a hernia |
| CN111839849A (en) * | 2020-07-17 | 2020-10-30 | 易浦润（上海）生物技术有限公司 | Urethral stent and preparation method and application thereof |
| CN114349996A (en) * | 2021-12-03 | 2022-04-15 | 广东省科学院健康医学研究所 | Super-smooth material and preparation method and application thereof |
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