CN104398329A - Completely-degradable net-shaped nasolacrimal stent and implantation system thereof - Google Patents
Completely-degradable net-shaped nasolacrimal stent and implantation system thereof Download PDFInfo
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- CN104398329A CN104398329A CN201410521759.4A CN201410521759A CN104398329A CN 104398329 A CN104398329 A CN 104398329A CN 201410521759 A CN201410521759 A CN 201410521759A CN 104398329 A CN104398329 A CN 104398329A
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Abstract
The invention relates to a completely-degradable net-shaped nasolacrimal stent. The completely-degradable net-shaped nasolacrimal stent comprises a sleeve-shaped net-shaped body made of biodegradable high polymer materials and provided with holes; a medicine coating is arranged on the surface of the net-shaped body; the net-shaped body is composed of a first net-shaped body part and a second net-shaped body part which are connected; in the compression state, the first net-shaped body part and the second net-shaped body part are the same in diameter; and in the expansion state, the diameter of the first net-shaped body part is larger than the diameter of the second net-shaped body part. After lumen rebuilding is completed, water and carbon dioxide are finally generated by the completely-degradable net-shaped nasolacrimal stent to be discharged through the nasal cavity; and second operations and pains of a patient are avoided. The nasolacrimal stent is suitable for approaching the body from the nasal cavity, so that injuries, caused by the fact that the nasolacrimal stent approaches the body from the positions above the eyes, to the lacrimal ductile and the nasolacrimal canal inner membrane are avoided. By means of the completely-degradable net-shaped nasolacrimal stent, the medicine slow release effect is achieved through the medicine coating; and continuous treatment on the nasolacrimal canal for a long time is accordingly achieved.
Description
Technical field
The present invention relates to the medical apparatus and instruments for ocular disease, relate more specifically to a kind of can be degradable netted lacrimal canal bracket and implant system.
Background technology
Obstruction of naso lacrimal duct and chronic dacryocystitis are common ocular disease, and current Therapeutic Method mainly contains probing of lacrimal passage and Dacryocystorhinostomy.Probing of lacrimal passage wound is little, simple to operate, but needs are repeatedly visited logical repeatedly, and increase the misery of sufferer, and relapse rate is high, therapeutic effect is poor.Dacryocystorhinostomy is as the modus operandi of classics, and object is that lachrymal sac and nasal mucosa are directly coincide, and makes secretions and tear directly enter middle nasal meatus by lachrymal sac, to eliminate the suppurative focus of lachrymal sac and to remove epiphora phenomenon.This operation method is treatment obstruction of naso lacrimal duct and the most effective method of chronic dacryocystitis, but operation relative complex, and will operate on, intraoperative hemorrhage is many, operating time is long, and the restore cycle is long, and postoperative face can leave cicatrix, and post-operative hospital stay is long, old people and child are not suitable for carrying out such operation.
For the deficiency of current Clinics, lacrimal canal bracket is used to treatment obstruction of naso lacrimal duct and chronic dacryocystitis, and its major advantage is that wound is little, operating time is short, recovers fast etc.Existing lacrimal canal bracket is that silica gel material is made, and after this stenter to implant, can recover the unimpeded of nasolacrimal duct in a short time, but after permanent implantation, may produce the inflammation much caused by stenter to implant, thus again blocks nasolacrimal duct passage.And most lacrimal canal bracket needs after 1-3 month to take out in implantation, if the narrow severe patient of bone can proper extension to one-year age.After implanting a period of time, support is understood and in nasolacrimal duct, mucosa is sticked together, and such lacrimal canal bracket just can not take out smoothly, can increase the misery of patient on the one hand, needs secondary implant frame to open the nasolacrimal duct of obstruction on the other hand.
Simultaneously, the implantation of above-mentioned existing lacrimal canal bracket is generally realized by the traction of lacrimal ductule seal wire: first use probing of lacrimal passages guid needle lacrimal passage probing, lacrimal ductule seal wire is through lacrimal passage probing needle nook closing member, until stretch out nasal cavity, then lacrimal ductule seal wire traction lacrimal canal bracket goes between, to pull-up seal wire above eye, until support is drawn in nose lacrimal passage.Because lacrimal ductule is tiny and weak structure, entering of lacrimal ductule seal wire can cause damage to lacrimal ductule on the one hand, causes suffering on the other hand to patient.The method for implantation of this lacrimal canal bracket is firmly comparatively large, because lacrimal canal bracket is comparatively thick, can damages nose lacrimal passage inner membrance, cause secondary injury, cause animally and misery larger mentally to patient.
Summary of the invention
The implantation of lacrimal canal bracket existed to solve above-mentioned prior art easily damages nose lacrimal passage inner membrance, and the taking-up of lacrimal canal bracket increases the problem of patient suffering, the present invention aim to provide a kind of can be degradable netted lacrimal canal bracket and implant system.
Of the present invention can be degradable netted lacrimal canal bracket, comprise the web body with hole of the sleeve-shaped formed by Biodegradable polymer material, the surface of described web body have medication coat; Described web body is made up of the first web body part be connected with each other and the second web body part; Under compression, described first web body part and described second web body part have identical diameter; Under expansion state, the diameter of described first web body part is greater than the diameter of described second web body part.
Lacrimal canal bracket of the present invention is formed by Biodegradable polymer material, and after tube chamber has been rebuild, this lacrimal canal bracket is degraded gradually, and finally generation water and carbon dioxide are discharged by nasal cavity.The netted lacrimal canal bracket of this Wholly-degradable avoids the postoperative taking-up as existing silica gel lacrimal canal bracket, avoids second operation, has reduced or remitted sufferer painful.This degradable high polymer material can adopt different polymer or copolymer, or adopts different processing modes, and as blended, the form such as hollow or interlayer regulates degradation speed, with the demand that the treatment cycle adapting to different sufferer is different.Lacrimal canal bracket of the present invention substantially envisages the stickiness of tube wall and devises the web body part of variable diameters, be suitable for from nasal cavity approach, thus avoid existing from the infringement of approach above eye to lacrimal ductule and nose lacrimal passage inner membrance, make the implantation of lacrimal canal bracket more convenient and easy, to be reduced to minimum to the injury of patient, and the web body part of this variable diameters can drain tear better due to laminating nose lacrimal passage.In addition, due to the restriction of the implantation of existing lacrimal canal bracket, the surface of existing lacrimal canal bracket does not comprise medicine, and lacrimal canal bracket of the present invention carrys out carrying medicament by support, effectively can treat nose lacrimal passage, and slow release can be realized as required.
This Biodegradable polymer material is selected from one or more in following material: degradable Polyurethane, degradable polyester, autohemagglutination (L-lactide--D-lactide altogether), poly-(L-lactide--D, L-lactide altogether), poly-(D-lactide--D, L-lactide altogether), PLG, poly-(lactide-altogether-6-caprolactone), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-6-caprolactone), poly-(lactide-totally-diethyleno dioxide ketones), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-totally-diethyleno dioxide ketones), poly-(lactide-altogether-trimethylene carbonate), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-trimethylene carbonate), poly-(lactide-altogether-ethylene carbonate), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-ethylene carbonate), poly-(lactide-altogether-Allyl carbonate), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-Allyl carbonate), poly-(lactide--2-methyl-2-carboxyl-Allyl carbonate altogether), poly-(Acetic acid, hydroxy-, bimol. cyclic ester--2-methyl-2-carboxyl-Allyl carbonate altogether), poly-(3-hydroxybutyrate ester-altogether-4 hydroxybutyric acid ester), poly-(butyric ester-altogether-hydroxyl valerate), poly-(3-hydroxybutyrate ester--3-hydroxyl valerate altogether), poly-(4 hydroxybutyric acid ester--3-hydroxyl valerate altogether), poly-(6-caprolactone-altogether-fumarate), poly-(6-caprolactone-altogether-fumaric acid propylene glycol ester), poly-(lactide-co-ethylene glycol), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-ethylene glycol), poly-(6-caprolactone-altogether-ethylene glycol), poly-(common-DETOSU-t-CDM of DETOSU-1,6-HD-), poly-(lactide-co-glycolide-altogether-6-caprolactone), poly-(lactide-co-glycolide-altogether-trimethylene carbonate), poly-(lactide-altogether-6-caprolactone-altogether-trimethylene carbonate), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-6-caprolactone-altogether-trimethylene carbonate) and poly-(3-hydroxybutyrate ester--3-hydroxyl valerate altogether-altogether-4 hydroxybutyric acid ester), lactide wherein comprises L-lactide, D-lactide and D, L-lactide.PVP, PVA, starch, biomolecule is (as fibrin, Fibrinogen, cellulose, collagen protein and hyaluronic acid), polyurethane, artificial silk, artificial silk Triafol T, cellulose, acetic acid, cellulose butyrate, acetylbutyrylcellulose, cellophane, celluloid, cellulose propionate, cellulose, and carboxymethyl cellulose.
Especially, this Biodegradable polymer material is the blended polymeric material of PLA and PGA (or PCL).On the one hand, this base polymer has been widely used in the three class medical device product such as intravascular stent, stitching thread, orthopaedics implant for many years, has biocompatibility more better than silica gel material, avoids the generation of the complication that some have material to cause.On the other hand, the present invention carries out proportioning according to the use position of the nose lacrimal passage of support, comprises and carries out proportioning with the requirement at specific use position according to the invention according to its support strength and degradation time etc.Wherein, the mass percent of PLA shared by the polymeric material that PGA and PLA is blended is at least 50%, is preferably 70%; The mass percent of PCL shared by the polymeric material that PLA and PCL is blended is at least 50%, is preferably 70%.So can guarantee that the degradation time of lacrimal canal bracket is about 3-6 month, support strength meets the demands simultaneously.
Can polymer blend except above-mentioned degradable polymer, also comprise the polymer of synthesis and natural hydrolytic degradation.The biodegradable polymer of synthesis hydrolysis can comprise hydrolytic degradation polyester and comprise poly-(Pfansteihl-glycolic) (PLGA).Typical natural biodegradable polymer comprises chitosan.Typical water-soluble polymer comprises PEG (PEG), PEG block polymer, PEG/PLA and PEG polymer, random or the alternate copolymer of PEG, as Polyethylene Glycol/PLGA copolymer, sucrose, starch, Algin, polyvinylpyrrolidone (PVP), and poly-(vinyl alcohol) (PVA).Poly-(N-acetyl-glucosamine) (chitin), poly-(ester), poly-(3-hydroxybutyrate ester), poly-(4 hydroxybutyric acid ester), poly-(hydroxybutyric acid-hydroxypentanoic acid), poly-(DL-lactide-co-caprolactone), poly-(Acetic acid, hydroxy-, bimol. cyclic ester is 6-caprolactone altogether), PTMC, polyesteramide, poly-(glycolic-trimethylene carbonate), gathers (ether-ester) (such as, PEO/ polylactic acid), polyphosphazene etc.
Described web body comprises support ring and connecting rod, and described support ring is the sinusoidal wave shape support ring closed that circumference extends, and described connecting rod is arranged between adjacent support ring.Wherein, described connecting rod can be linear or other shapes, makes it form one as long as support ring can be connected.
Described support ring is joined end to end by the unit repeated and is formed, and the number of the unit of described first web body part is more than the number of the unit of described second web body part.
Described unit is V-arrangement unit, more than the number of the V-arrangement unit of described second web body part 2-3 of the number of the V-arrangement unit of described first web body part.Preferably, the number of the V-arrangement unit of described first web body part is 7-10, and the number of the V-arrangement unit of described second web body part is 5-8.
The outer surface of described web body have anti-inflammatory drug or tissue adhesion medicine.After lacrimal canal bracket is implanted, the anti-inflammatory drug of web body outer surface or tissue adhesion medicine start the nasolacrimal duct release to contacting with it, decrease the inflammation of nasolacrimal duct inwall, granulation growth, and accelerate the healing of nose lacrimal passage.
In certain embodiments, anti-inflammatory drug comprises, but be not limited to, alclofenac, alclometasone double propionate, algestone triamcinolone acetonide, α-amylase, amcinafal, amcinafide, amfenac sodium, amiprilose hydrochloride, Antril (Synergen), anirolac, anitrazafen, azapropazone, balsalazide sodium, benzyl Dalai, benzydamine hydrochloride, bromelain, Broperamole, budesonide, carprofen, cicloprofen, cinnopentazone, cliprofen, propanoic acid, clobetasol propionate, clopirac, cloticasone propanoic acid, cormethasone acetate, cortisone, deflazacort, desonide, desoximetasone, propanoic acid dexamethasone, diclofenac potassium, sodium, acetic acid is two, diflumidone sodium, diflunisal, difluprednate, diftalone, dimethyl sulfoxide, drocinonide, endrysone, enlimomab, enolicam sodium, epirizole, etodolac, etofenamate, felbinac, fenamole, fenbufen, chloric acid, fenclorac, fendosal, fenpipalone, fentiazac, flazalone, Fluazacort, flufenamic acid, flumizole, flunisolide acetate, flunixin, flunixin meglumine, fluorometholone acetate, afloqualone, fluorine, fluretofen, fluticasone propionate, furaprofen, vomitory processed, monoxone, halobetasol propionate, halopredone, ibufenac, ibuprofen, ibuprofen aluminum, ibuprofen piconol, Yi Luopu, indomethacin indomethacin, sodium, indoprofen, indoxole, acetate, Isoxepac, isoxicam, ketoprofen, lofemizole hydrochloride, lornoxicam, loteprednol, meclofenamate sodium, acidum clofenamicum, meclorisone dibutyrate, mefenamic acid, mesalazine, meseclazone, methylprednisolone, nabumetone, naproxen, naphthalene, naproxol, nimazone, olsalazine sodium, organophosphor, orpanoxin, oxaprozin, crovaril, paranyline hydrochlorate, phenbutazone sodium glycerate, pirfenidone, piroxicam, piroxicam cinnamic acid, piroxicam olamine, pirprofen, meticortelone-perphenazine, prifelone, prodolic acid, proxazole, proxazole citrate, rimexolone, lobenzarit, salcolex, Salnacedin, salicyl salicylate (salsalate), red root chlorophyll agency commission, seclazone, sermetacin, sudoxicam, sulindac, suprofen, talmetacin, talniflumate, Talosalate, Tebufelone, tenidap, tenidap sodium, tenoxicam, tesicam, tesimide, tetrydamine, tiopinac, tolmetin, Tolmetin sodium, triclonide, triflumidate, zidometacin, compacted spore rhzomorph, aspirin (aspirin), salicylic acid, glucocorticoid, glucocorticoid, tacrolimus, and their combination.
Implant system of the present invention, comprises above-mentioned lacrimal canal bracket.
Described implant system also comprises foley's tube, and described foley's tube comprises the sacculus for pre-installing described lacrimal canal bracket, and described sacculus is made up of the first balloon portion and the second balloon portion; Under compression, described first balloon portion and described first web body section aligned, described second balloon portion and described second web body section aligned; Under expansion state, the diameter of described first balloon portion is greater than the diameter of described second balloon portion.
The foley's tube of implant system of the present invention is the sacculus designed according to the anatomical structure of nasolacrimal duct, thus lacrimal canal bracket is strutted the outer wall laminating nose lacrimal passage making lacrimal canal bracket, plays the supporting role making nose lacrimal passage unimpeded.
Under expansion state, full in described sacculus have contrast agent.Certainly, other liquid is also feasible, considers that later-stage utilization X-ray carries out the convenience of observing, and it is particularly preferred for using contrast agent to carry out full.
Described implant system also comprises nasolacrimal duct dilator, described nasolacrimal duct dilator is made up of bar in nose lacrimal dilator trocar sheath and nose lacrimal dilator, and in described nose lacrimal dilator, bar is placed at least partly in described nose lacrimal dilator trocar sheath and also removably coordinates with it.After entering nose lacrimal passage, nose lacrimal dilator trocar sheath is left on original position as a service aisle, and the operation in later stage is all undertaken by this passage.
Described implant system also comprises illuminating guidewire, and described nasolacrimal duct dilator extends along described illuminating guidewire.In implantation process, first use illuminating guidewire from nasal cavity approach, make illuminating guidewire arrive lachrymal sac position, then implant in nose lacrimal passage along illuminating guidewire cue lachrymal canal dilator, extract bar in nose lacrimal dilator out, the indwelling of nose lacrimal dilator trocar sheath in nasolacrimal duct as surgical work passage.The lacrimal canal bracket system be contained in advance on foley's tube is sent in nasolacrimal duct along nose lacrimal dilator trocar sheath, to foley's tube pressurization, realizes the expansion of support.Method so no longer by implanting from lacrimal ductule traction is drawn in lacrimal canal bracket in nose lacrimal passage, and adopt from nasal cavity approach completely, thus avoid the drawback of existing method for implantation, make the implantation of lacrimal canal bracket more convenient and easy, the injury of patient is minimized.
Described illuminating guidewire is made up of helical spring, lens and optical cable, and described lens are fixed on the illumination end of described optical cable, and described helical spring is wrapped in the outside of described optical cable in described illumination end.Substitute existing lacrimal ductule seal wire, illuminating guidewire provided by the invention, from nasal cavity approach, because nasal cavity is thick, can not produce infringement, and the misery experienced of sufferer is reduced greatly to nose lacrimal passage.
Described illuminating guidewire is made up of helical spring, lens and optical cable, and described lens are fixed on the illumination end of described optical cable, and described helical spring is wrapped in the outside of described optical cable in described illumination end.
After tube chamber has been rebuild, netted lacrimal canal bracket that can be degradable of the present invention has finally generated water and carbon dioxide is discharged by nasal cavity, avoids second operation, has reduced or remitted sufferer painful.This lacrimal canal bracket is suitable for from nasal cavity approach, thus avoids existing from the infringement of approach above eye to lacrimal ductule and nose lacrimal passage inner membrance.This lacrimal canal bracket realizes medicament slow release effect by medication coat, thus carries out continued treatment to nose lacrimal passage for a long time.
Accompanying drawing explanation
Fig. 1 is the plane outspread drawing of the lacrimal canal bracket according to implant system of the present invention;
Fig. 2 is the perspective view of the foley's tube according to implant system of the present invention;
Fig. 3 is the perspective view of the illuminating guidewire according to implant system of the present invention;
Fig. 4 is the perspective view of the nasolacrimal duct dilator according to implant system of the present invention;
Fig. 5 is the perspective view of the nose lacrimal dilator trocar sheath according to implant system of the present invention;
Fig. 6 is the perspective view of bar in the nose lacrimal dilator according to implant system of the present invention.
Detailed description of the invention
Below in conjunction with accompanying drawing, provide preferred embodiment of the present invention, and be described in detail.
According to the support that the lacrimal canal bracket of implant system of the present invention is sleeve-shaped, convenient in order to describe, Fig. 1 gives the plane outspread drawing of this lacrimal canal bracket.Lacrimal canal bracket 1 comprises the web body 11 with hole formed by Biodegradable polymer material, such as, can become mesh-like structure by carrying out laser engraving on the extruding pipe material of degradable polymeric material.This web body 11 comprises support ring 111 and connecting rod 112, and wherein, support ring 111 is the sinusoidal wave shape support ring closed that circumference extends, and each support ring is joined end to end by the V-arrangement unit 111a repeated and formed.Connecting rod 112 is arranged between adjacent support ring 111.Support ring 111 mainly plays a supportive role to the nasolacrimal duct of blocking, forms an entirety between support ring 111 by connecting rod 112.Web body 11 is made up of the first web body part 11a be connected with each other and the second web body part 11b, wherein the first web body part 11a is implanted in the epimere of nose lacrimal passage, namely near lachrymal sac section, second web body part 11b is implanted in the lower end of nose lacrimal passage, i.e. nearly nasolacrimal duct nasal cavity aperture position.Form the number of number more than the V-arrangement unit 111a of the support ring 111 of the second web body part 11b of the V-arrangement unit 111a of the support ring 111 of the first web body part 11a.Usually, the number forming the V-arrangement unit 111a of the support ring 111 of the first web body part 11a is 7-10, the number forming the V-arrangement unit 111a of the support ring 111 of the second web body part 11b is 5-8, and the number of the V-arrangement unit 111a of the support ring 111 of the first web body part 11a is preferably more than the number of the V-arrangement unit 111a of the support ring 111 of formation second web body part 11b 2-3.This lacrimal canal bracket has two states---compressive state and expansion state.Under compression, the first web body part 11a and the second web body part 11b has identical diameter; Under expansion state, the diameter of the first web body part 11a is greater than the diameter of the second web body part 11b.So, after expansion, this lacrimal canal bracket is fixed near lachrymal sac section by means of large diameter first web body part 11a, prevents it from inadvertently deviating from from nasal cavity.Usually, the width W 1 of support ring 111 is 0.1-0.5mm, is preferably 0.2-0.3mm.The width W 2 of connecting rod 112 is preferably 0.1-0.3mm, and this connecting rod 112 can be linear as shown in Figure 1, also can be other shapes.The thickness of this lacrimal canal bracket can be 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, is preferably 0.2-0.5mm.
The outer surface of web body 11 have anti-inflammatory drug or tissue adhesion medicine.Preferably, the outer surface of web body 11 is formed the medication coat of anti-inflammatory drug or tissue adhesion medicine by spraying, thus prevent inflammation and granulation growth in nose lacrimal passage by means of the release of medicine.This anti-inflammatory drug comprises, but be not limited to, alclofenac, alclometasone double propionate, algestone triamcinolone acetonide, α-amylase, amcinafal, amcinafide, amfenac sodium, amiprilose hydrochloride, Antril (Synergen), anirolac, anitrazafen, azapropazone, balsalazide sodium, benzyl Dalai, benzydamine hydrochloride, bromelain, Broperamole, budesonide, carprofen, cicloprofen, cinnopentazone, cliprofen, propanoic acid, clobetasol propionate, clopirac, cloticasone propanoic acid, cormethasone acetate, cortisone, deflazacort, desonide, desoximetasone, propanoic acid dexamethasone, diclofenac potassium, sodium, acetic acid is two, diflumidone sodium, diflunisal, difluprednate, diftalone, dimethyl sulfoxide, drocinonide, endrysone, enlimomab, enolicam sodium, epirizole, etodolac, etofenamate, felbinac, fenamole, fenbufen, chloric acid, fenclorac, fendosal, fenpipalone, fentiazac, flazalone, Fluazacort, flufenamic acid, flumizole, flunisolide acetate, flunixin, flunixin meglumine, fluorometholone acetate, afloqualone, fluorine, fluretofen, fluticasone propionate, furaprofen, vomitory processed, monoxone, halobetasol propionate, halopredone, ibufenac, ibuprofen, ibuprofen aluminum, ibuprofen piconol, Yi Luopu, indomethacin indomethacin, sodium, indoprofen, indoxole, acetate, Isoxepac, isoxicam, ketoprofen, lofemizole hydrochloride, lornoxicam, loteprednol, meclofenamate sodium, acidum clofenamicum, meclorisone dibutyrate, mefenamic acid, mesalazine, meseclazone, methylprednisolone, nabumetone, naproxen, naphthalene, naproxol, nimazone, olsalazine sodium, organophosphor, orpanoxin, oxaprozin, crovaril, paranyline hydrochlorate, phenbutazone sodium glycerate, pirfenidone, piroxicam, piroxicam cinnamic acid, piroxicam olamine, pirprofen, meticortelone-perphenazine, prifelone, prodolic acid, proxazole, proxazole citrate, rimexolone, lobenzarit, salcolex, Salnacedin, salicyl salicylate (salsalate), red root chlorophyll agency commission, seclazone, sermetacin, sudoxicam, sulindac, suprofen, talmetacin, talniflumate, Talosalate, Tebufelone, tenidap, tenidap sodium, tenoxicam, tesicam, tesimide, tetrydamine, tiopinac, tolmetin, Tolmetin sodium, triclonide, triflumidate, zidometacin, compacted spore rhzomorph, aspirin (aspirin), salicylic acid, glucocorticoid, glucocorticoid, tacrolimus, and their combination.
Form one or more that the Biodegradable polymer material of web body 11 is selected from following material: degradable Polyurethane, degradable polyester, autohemagglutination (L-lactide--D-lactide altogether), poly-(L-lactide--D, L-lactide altogether), poly-(D-lactide--D, L-lactide altogether), PLG, poly-(lactide-altogether-6-caprolactone), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-6-caprolactone), poly-(lactide-totally-diethyleno dioxide ketones), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-totally-diethyleno dioxide ketones), poly-(lactide-altogether-trimethylene carbonate), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-trimethylene carbonate), poly-(lactide-altogether-ethylene carbonate), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-ethylene carbonate), poly-(lactide-altogether-Allyl carbonate), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-Allyl carbonate), poly-(lactide--2-methyl-2-carboxyl-Allyl carbonate altogether), poly-(Acetic acid, hydroxy-, bimol. cyclic ester--2-methyl-2-carboxyl-Allyl carbonate altogether), poly-(3-hydroxybutyrate ester-altogether-4 hydroxybutyric acid ester), poly-(butyric ester-altogether-hydroxyl valerate), poly-(3-hydroxybutyrate ester--3-hydroxyl valerate altogether), poly-(4 hydroxybutyric acid ester--3-hydroxyl valerate altogether), poly-(6-caprolactone-altogether-fumarate), poly-(6-caprolactone-altogether-fumaric acid propylene glycol ester), poly-(lactide-co-ethylene glycol), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-ethylene glycol), poly-(6-caprolactone-altogether-ethylene glycol), poly-(common-DETOSU-t-CDM of DETOSU-1,6-HD-), poly-(lactide-co-glycolide-altogether-6-caprolactone), poly-(lactide-co-glycolide-altogether-trimethylene carbonate), poly-(lactide-altogether-6-caprolactone-altogether-trimethylene carbonate), poly-(Acetic acid, hydroxy-, bimol. cyclic ester-altogether-6-caprolactone-altogether-trimethylene carbonate) and poly-(3-hydroxybutyrate ester--3-hydroxyl valerate altogether-altogether-4 hydroxybutyric acid ester), lactide wherein comprises L-lactide, D-lactide and D, L-lactide.PVP, PVA, starch, biomolecule is (as fibrin, Fibrinogen, cellulose, collagen protein and hyaluronic acid), polyurethane, artificial silk, artificial silk Triafol T, cellulose, acetic acid, cellulose butyrate, acetylbutyrylcellulose, cellophane, celluloid, cellulose propionate, cellulose, and carboxymethyl cellulose.
Especially, this Biodegradable polymer material is the blended polymeric material of PLA and PGA (or PCL).On the one hand, this base polymer has been widely used in the three class medical device product such as intravascular stent, stitching thread, orthopaedics implant for many years, has biocompatibility more better than silica gel material, avoids the generation of the complication that some have material to cause.On the other hand, the present invention carries out proportioning according to the use position of the nasolacrimal duct of support, comprises and carries out proportioning with the requirement at specific use position according to the invention according to its support strength and degradation time etc.Wherein, the mass percent of PLA shared by the polymeric material that PGA and PLA is blended is at least 50%, is preferably 70%; The mass percent of PCL shared by the polymeric material that PLA and PCL is blended is at least 50%, is preferably 70%.So can guarantee that the degradation time of lacrimal canal bracket is about 3-6 month, support strength meets the demands simultaneously.
Can polymer blend except above-mentioned degradable polymer, also comprise the polymer of synthesis and natural hydrolytic degradation.The biodegradable polymer of synthesis hydrolysis can comprise hydrolytic degradation polyester and comprise poly-(Pfansteihl-glycolic) (PLGA).Typical natural biodegradable polymer comprises chitosan.Typical water-soluble polymer comprises PEG (PEG), PEG block polymer, PEG/PLA and PEG polymer, random or the alternate copolymer of PEG, as Polyethylene Glycol/PLGA copolymer, sucrose, starch, Algin, polyvinylpyrrolidone (PVP), and poly-(vinyl alcohol) (PVA).Poly-(N-acetyl-glucosamine) (chitin), poly-(ester), poly-(3-hydroxybutyrate ester), poly-(4 hydroxybutyric acid ester), poly-(hydroxybutyric acid-hydroxypentanoic acid), poly-(DL-lactide-co-caprolactone), poly-(Acetic acid, hydroxy-, bimol. cyclic ester is 6-caprolactone altogether), PTMC, polyesteramide, poly-(glycolic-trimethylene carbonate), gathers (ether-ester) (such as, PEO/ polylactic acid), polyphosphazene etc.
Fig. 2 shows the foley's tube 2 for pre-installing described lacrimal canal bracket 1 according to implant system of the present invention, comprises sacculus 21, conduit 22 and luer connector element 23.Wherein, sacculus 21 is made up of the first balloon portion 21a and the second balloon portion 21b.In the embodiment shown in Figure 2, this sacculus 21 is depicted as notch cuttype sacculus, and under expansion state, the diameter 2-5mm larger than the diameter of the second balloon portion 21b of the first balloon portion 21a, is preferably large 2-3mm.Certainly, this sacculus 21 also can be other variable diameters sacculus, the taper sacculus of such as gentle transition.In order to the web body 11 of lacrimal canal bracket 1 is formed required shape, the first balloon portion 21a aligns with the first web body part 11a, and the second balloon portion 21b aligns with the second web body part 11b.By this foley's tube, lacrimal canal bracket 1 of the present invention can be made to adopt lower nasal cavity approaches, send into lacrimal canal bracket 1 from nasolacrimal duct nasal cavity aperture position.After lacrimal canal bracket 1 reaches lesion locations, use pressurized equipment, as full device, connecting the luer connector element 23 of foley's tube, by filling contrast agent dilating sacculus 21 to conduit 22, lacrimal canal bracket 1 being strutted.Because the first balloon portion 21a is different with the diameter of the second balloon portion 21b, the first web body part 11a then under expansion state is not identical with the diameter of the second web body part 11b yet, large diameter first web body part 11a corresponds to lachrymal sac position, can prevent support from gliding like this and be shifted.Then foley's tube 2 is removed in pressure release, and lacrimal canal bracket 1 stays in nasolacrimal duct the supporting role played and make nose lacrimal passage unimpeded.After tube chamber has been rebuild, the netted lacrimal canal bracket that this can be degradable has been degraded gradually, and finally generation water and carbon dioxide are discharged by nasal cavity.
Foley's tube 2 also can be used alone, and does not namely pre-install lacrimal canal bracket.The outer surface of sacculus 21 can have anti-inflammatory drug or tissue adhesion medicine, when balloon expandable, and lacrimal canal fold contacts.On sacculus, medicine directly acts on nose lacrimal passage.This anti-inflammatory drug comprises, but be not limited to, alclofenac, alclometasone double propionate, algestone triamcinolone acetonide, α-amylase, amcinafal, amcinafide, amfenac sodium, amiprilose hydrochloride, Antril (Synergen), anirolac, anitrazafen, azapropazone, balsalazide sodium, benzyl Dalai, benzydamine hydrochloride, bromelain, Broperamole, budesonide, carprofen, cicloprofen, cinnopentazone, cliprofen, propanoic acid, clobetasol propionate, clopirac, cloticasone propanoic acid, cormethasone acetate, cortisone, deflazacort, desonide, desoximetasone, propanoic acid dexamethasone, diclofenac potassium, sodium, acetic acid is two, diflumidone sodium, diflunisal, difluprednate, diftalone, dimethyl sulfoxide, drocinonide, endrysone, enlimomab, enolicam sodium, epirizole, etodolac, etofenamate, felbinac, fenamole, fenbufen, chloric acid, fenclorac, fendosal, fenpipalone, fentiazac, flazalone, Fluazacort, flufenamic acid, flumizole, flunisolide acetate, flunixin, flunixin meglumine, fluorometholone acetate, afloqualone, fluorine, fluretofen, fluticasone propionate, furaprofen, vomitory processed, monoxone, halobetasol propionate, halopredone, ibufenac, ibuprofen, ibuprofen aluminum, ibuprofen piconol, Yi Luopu, indomethacin indomethacin, sodium, indoprofen, indoxole, acetate, Isoxepac, isoxicam, ketoprofen, lofemizole hydrochloride, lornoxicam, loteprednol, meclofenamate sodium, acidum clofenamicum, meclorisone dibutyrate, mefenamic acid, mesalazine, meseclazone, methylprednisolone, nabumetone, naproxen, naphthalene, naproxol, nimazone, olsalazine sodium, organophosphor, orpanoxin, oxaprozin, crovaril, paranyline hydrochlorate, phenbutazone sodium glycerate, pirfenidone, piroxicam, piroxicam cinnamic acid, piroxicam olamine, pirprofen, meticortelone-perphenazine, prifelone, prodolic acid, proxazole, proxazole citrate, rimexolone, lobenzarit, salcolex, Salnacedin, salicyl salicylate (salsalate), red root chlorophyll agency commission, seclazone, sermetacin, sudoxicam, sulindac, suprofen, talmetacin, talniflumate, Talosalate, Tebufelone, tenidap, tenidap sodium, tenoxicam, tesicam, tesimide, tetrydamine, tiopinac, , tolmetin, Tolmetin sodium, triclonide, triflumidate, zidometacin, compacted spore rhzomorph, aspirin (aspirin), salicylic acid, glucocorticoid, glucocorticoid, tacrolimus, and their combination.
Implant system of the present invention also comprises implanting instrument, and this implanting instrument comprises illuminating guidewire 3 and nasolacrimal duct dilator 4, and wherein, Fig. 3 shows illuminating guidewire; Fig. 4-Fig. 6 shows nasolacrimal duct dilator.First use illuminating guidewire 3 from nasal cavity approach, illuminating guidewire 3 is made to arrive lachrymal sac position, then implant in nose lacrimal passage along illuminating guidewire cue lachrymal canal dilator 4, extract bar 42 in nose lacrimal dilator out, the indwelling of nose lacrimal dilator trocar sheath 41 in nasolacrimal duct as surgical work passage.The lacrimal canal bracket system be contained in advance on foley's tube 2 is sent in nasolacrimal duct along nose lacrimal dilator trocar sheath 41, to foley's tube pressurization, realizes the expansion of support.This implanting instrument can adopt 304 rustless steels, 316L rustless steel or the materials processing such as polyurethane, Merlon to form.
Implant system of the present invention also comprises illuminating guidewire, and Fig. 3 shows the structure of this illuminating guidewire 3, and be made up of helical spring 33, lens 32 and optical cable 31, lens 32 are fixed on the illumination end of optical cable 31, and helical spring 33 is wrapped in the outside of optical cable 31 in illumination end.The other end relative with illumination end of optical cable 31 is connected with general laser transmitting illuminant, laser is propagated by this optical cable 31, emits in the position of lens 32, forms a laser bright spot.By illuminating guidewire 3 from nasal cavity opening part approach, probe into nose lacrimal passage, utilize this laser bright spot observe and decide illuminating guidewire 3 whether to be positioned at nasolacrimal duct assigned address.If illuminating guidewire 3 arrives target location, then turn off light source switch, and remove laser light emitting light source.The tapering point of illuminating guidewire 3 from nasolacrimal duct dilator 4 is penetrated, and nasolacrimal duct dilator 4 arrives assigned address in nasolacrimal duct along illuminating guidewire 3.By means of this helical spring 33, illuminating guidewire 3 can more successfully enter from nasal cavity opening part.
As shown in Figure 4, nasolacrimal duct dilator 4 is made up of bar 42 in nose lacrimal dilator trocar sheath 41 and nose lacrimal dilator.Wherein, Fig. 5 illustrates this nose lacrimal dilator trocar sheath 41, is made up of tapered end 411, supervisor 412 and handle 413.Fig. 6 illustrates bar 42 in this nose lacrimal dilator, is made up of cone expansion tip 421, supervisor 422 and handle 423.In nose lacrimal dilator, bar 42 is placed at least partly in nose lacrimal dilator trocar sheath 41 and also removably coordinates with it.The tapered end 411 of nose lacrimal dilator trocar sheath 41 is identical with the tapering at the cone expansion tip 421 of bar 42 in nose lacrimal dilator, and its tapering is preferably 1:2-1:3.The internal diameter 0.03-0.2mm larger than the external diameter of the supervisor 422 of bar in nose lacrimal dilator 42 of the supervisor 412 of nose lacrimal dilator trocar sheath 41, is preferably large 0.05-0.1mm.In nose lacrimal dilator, bar 42 is inserted by the handle openings 413a of nose lacrimal dilator trocar sheath 41, thus coordinates with nose lacrimal dilator trocar sheath 41 the nasolacrimal duct dilator 4 formed as shown in Figure 4.
Using method according to implant system of the present invention is described below in detail:
S1, coordinates in handle openings 413a bar 42 in nose lacrimal dilator being inserted nose lacrimal dilator trocar sheath 41 and forms nasolacrimal duct dilator 4.
S2, by illuminating guidewire 3 from nasal cavity opening part approach, probes into nose lacrimal passage, until reach lachrymal sac position.
S3, stretches into the illuminating guidewire 3 of the nasolacrimal duct dilator 4 of step S1 along step S2 in nose lacrimal passage from nasal cavity opening part.
S4, is retained in nose lacrimal dilator trocar sheath 41 in nose lacrimal passage, withdraws from bar 42 and illuminating guidewire 3 in nose lacrimal dilator.
S5, is preloaded onto lacrimal canal bracket 1 on foley's tube 2.
S6, sends in nasolacrimal duct by the foley's tube 2 of step S5 along nose lacrimal dilator trocar sheath 41, then makes lacrimal canal bracket 1 change expansion state into by contraction state by means of the full of sacculus 21 and be supported in nose lacrimal passage.
Above-described, be only preferred embodiment of the present invention, and be not used to limit scope of the present invention, the above embodiment of the present invention can also make a variety of changes.Namely every claims according to the present patent application and description are done simple, equivalence change and modify, and all fall into the claims of patent of the present invention.The not detailed description of the present invention be routine techniques content.
Claims (11)
1. a netted lacrimal canal bracket that can be degradable, it is characterized in that, described lacrimal canal bracket (1) comprises the web body (11) with hole of the sleeve-shaped formed by Biodegradable polymer material, and the surface of described web body (11) has medication coat; Described web body (11) is made up of the first web body part (11a) be connected with each other and the second web body part (11b); Under compression, described first web body part (11a) and described second web body part (11b) have identical diameter; Under expansion state, the diameter of described first web body part (11a) is greater than the diameter of described second web body part (11b).
2. lacrimal canal bracket according to claim 1, it is characterized in that, described web body (11) comprises support ring (111) and connecting rod (112), described support ring (111) is the sinusoidal wave shape support ring closed that circumference extends, and described connecting rod (112) is arranged between adjacent support ring (111).
3. lacrimal canal bracket according to claim 2, it is characterized in that, described support ring (111) is joined end to end by the unit repeated (111a) and is formed, and the number of the unit (111a) of described first web body part (11a) is more than the number of the unit (111a) of described second web body part (11b).
4. lacrimal canal bracket according to claim 3, it is characterized in that, described unit (111a) is V-arrangement unit, more than the number of the V-arrangement unit of described second web body part (11b) 2-3 of the number of the V-arrangement unit of described first web body part (11a).
5. lacrimal canal bracket according to claim 1, is characterized in that, the outer surface of described web body (11) has anti-inflammatory drug or tissue adhesion medicine.
6. an implant system, is characterized in that, described implant system comprises the lacrimal canal bracket (1) according to any one of the claims.
7. implant system according to claim 6, it is characterized in that, described implant system also comprises the foley's tube (2) for pre-installing described lacrimal canal bracket (1), described foley's tube (2) comprises sacculus (21), and described sacculus (21) is made up of the first balloon portion (21a) and the second balloon portion (21b); Under compression, described first balloon portion (21a) is alignd with described first web body part (11a), and described second balloon portion (21b) is alignd with described second web body part (11b); Under expansion state, the diameter of described first balloon portion (21a) is greater than the diameter of described second balloon portion (21b).
8. implant system according to claim 7, is characterized in that, under expansion state, full in described sacculus (21) have contrast agent.
9. implant system according to claim 6, it is characterized in that, described implant system also comprises nasolacrimal duct dilator (4), described nasolacrimal duct dilator (4) is made up of bar (42) in nose lacrimal dilator trocar sheath (41) and nose lacrimal dilator, and in described nose lacrimal dilator, bar (42) is placed at least partly in described nose lacrimal dilator trocar sheath (41) and also removably coordinates with it.
10. implant system according to claim 9, is characterized in that, described implant system also comprises illuminating guidewire (3), and described nasolacrimal duct dilator (4) extends along described illuminating guidewire (3).
11. implant systems according to claim 10, it is characterized in that, described illuminating guidewire (3) is made up of helical spring (33), lens (32) and optical cable (31), described lens (32) are fixed on the illumination end of described optical cable (31), and described helical spring (33) is wrapped in the outside of described optical cable (33) in described illumination end.
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| CN201410521759.4A CN104398329A (en) | 2014-09-30 | 2014-09-30 | Completely-degradable net-shaped nasolacrimal stent and implantation system thereof |
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| CN201410521759.4A CN104398329A (en) | 2014-09-30 | 2014-09-30 | Completely-degradable net-shaped nasolacrimal stent and implantation system thereof |
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| CN107669379A (en) * | 2017-11-08 | 2018-02-09 | 柏文有限责任公司 | Medical rack |
| CN109998748A (en) * | 2019-03-09 | 2019-07-12 | 苏州莱诺医疗器械有限公司 | A kind of lacrimal canal bracket fully absorbed and its transportation system |
| CN113180896A (en) * | 2021-04-19 | 2021-07-30 | 复旦大学附属中山医院 | Degradable support for preventing and treating esophageal stenosis |
| CN114652511A (en) * | 2022-05-19 | 2022-06-24 | 茂名市人民医院 | Medicine-carrying degradable lacrimal passage suppository |
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Application publication date: 20150311 |