CN108309555A

CN108309555A - A kind of anti-glaucoma surgery scarring inhibits and avascular filtering bleb maintenance tool

Info

Publication number: CN108309555A
Application number: CN201810339810.8A
Authority: CN
Inventors: 石凡军
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-04-16
Filing date: 2018-04-16
Publication date: 2018-07-24

Abstract

The present invention relates to a kind of tool being implanted into glaucoma filtration operation, which can carry and the various anti-post-surgical scarring drugs of micro sustained release, and can supplement injection of medicine after drug depletion；The tool can also promote and safeguard the formation of patient's filtration bleb automatically by physical action simultaneously.The tool is mainly made of 3 parts：1, shell；2, medicament slow release pouch；3, drug.This tool also has the simple version to be：" 1, shell " and " 2, medicament slow release pouch " is combined into one, and shell mechanism simplifies on a small quantity, and each parameter such as size, shape and installation and application method are basically unchanged.The tool（Or its simple version）Pass through the number of ways such as drug and physical action so that the aqueous humor filtering function of glaucoma filtration surgery more " lasting " significantly improves the " long-term " efficient of glaucoma filtration surgery, reduces recurrence after operation rate.It is particularly suitable for the operative treatment of various " refractory type " glaucomas.

Description

A kind of anti-glaucoma surgery scarring inhibits and avascular filtering bleb maintenance tool

Technical field

The present invention relates to a kind of tool being implanted into glaucoma filtration operation, which being capable of effectively prevention of postoperative filter Cross the healing in channel so that the aqueous humor filtering function of glaucoma filtration surgery more " lasting " significantly improves glaucoma filtration surgery Success rate, reduce recurrence after operation rate.

Background technology

Glaucoma filtration operation is a kind of the most frequently used in various resisting glaucoma operations, also most classical modus operandi.Its Whether success or not is to establish effective permanent aqueous humor flow pass and evaluate.The healing of its wound has unique want It asks, i.e. bulbar conjunctiva wound healing is complete, and subconjunctival tissue will heal not entirely, but scleral flap and filtration internal orifice are then complete Disunion could establish filtration bleb in this way, ensure that aqueous humor permanently flows out.And filtering surgery itself, it is one to body The artificial wound of kind, the filtration channel especially established, the even more direct wound of eyeball, since body has self-healing energy to wound mouth Operative failure is then declared, in other words glaucoma " recurrence " in power, filtration channel once healing.This namely in a sense, One of the reason of glaucoma " can not completely cure ".So ensure that subconjunctival tissue healing is not complete, and in scleral flap and filtration The complete disunion of mouth is the key that successful surgery to maintain good " filtration bleb ".Although all the time, both at home and abroad Researcher continuously attempts to various methods, to delay to filter the healing in channel, a variety of related tools has also been invented, but there has been no any A kind of tool, can be perfect, and permanently solves the healing problems in filtration channel.So far, the validity of Glaucoma Surgery It is still ophthalmology educational circles a great problem urgently to be resolved hurrily with persistence.

The method and tool of currently used anti-filtration channel healing, are mainly the following：

1. in art or it is postoperative use anti-scarring drug

Brief introduction --- it gains public acceptance both at home and abroad at present and clinical widely used antimetabolite is mitomycin C（mitomycin- C,MMC）, 5 FU 5 fluorouracil (5-fluorouracil, 5-FU）.

Application method --- MMC, using relatively more generally in art, substantially application method is：Immersed with 0.2 mg/ml The cotton piece of MMC is placed in 1~4 min under below scleral valve and conjunctival flap, then with 200 ml physiological saline cleaning downs；5-FU, The postoperative application of trabecular resection is more, and general application method is：When early postoperation discovery non-functional avascular filtering bleb, that is, filter surface channel When facing healing danger, through subconjunctival injection 5-FU, filtration channel and avascular filtering bleb scarring are prevented, it is then thorough with a large amount of physiological saline Bottom is rinsed.

There are the problem of ---（1）Disposable, drug cannot be sustained, and antiscarring effect is apparent in a short time, but difficult Persistently to play a role, still there is higher filtration risk of failure in the later stage；（2）Anti-scarring drug is in filtration surgery or postoperative straight Use is connect, drug can be caused to outflow, influences conjunctiva wound healing, and generates some toxicities, such as persistent ocular hypotony and shallow Anterior chamber, cornea and conjunctival epithelium defect, wound leakage, filter follicular rupture and infection, choroidal detachment, ocular hypotension ARM Deng.Therefore, this kind of drug is served only for the patient of filtration surgery failure risk factor or the use in conjunction of Refractory Glaucoma, no As in glaucoma filtering surgery and postoperative conventional application.

2. composite trabeculectomy joint amnion transplantation

Brief introduction --- fresh amnion or bioamnion are selected, is applied in trabeculectomy, so that inflammatory cell is withered using amnion It dies, inhibits the effect of new vessels and fibroproliferation, and act on using mechanical barrier of the amnion between scleral flap and sclera bed, Prevent the scar healing of filtration internal orifice.

Application method --- in trabeculectomy in late primary glaucoma, after scleral flap is made, by fresh amnion, or biological sheep Film is placed in below scleral valve, then completes subsequent surgical procedure again.

There are the problem of --- amnion can dissolve for general 2 weeks or so, in a short time prevent filtration internal orifice scar healing effect compared with Significantly, but long-term effect is difficult to maintain.

3. aqueous humor drainage device for glaucoma（Glaucoma drainage device, GDD）Implantation

Brief introduction --- aqueous humor drainage device for glaucoma more advanced at present has " Ahmed drain valves " and " sclera nail " etc..

Application method --- in order to avoid filtration internal orifice healing, filtration is caused to fail, across filtration internal orifice, implantation when operation A piece drainage pipe, by outside aqueous humor drainage to sclera, under bulbar conjunctiva.By taking Ahmed drain valves as an example：Aqueous humor is drawn by drainage tube It flow on the outer attachment of the sclera near ambitus, an aqueous humor impoundment dedicated is formed and keep in the area, to shape At permanent aqueous humor drainage channel.

There are the problem of ---（1）It at postoperative initial stage, filtered smooth, it is de- to form the anterior chamber of duration, Ocular hypotension, choroid From, ocular hypotension ARM etc.；（2）Postoperative later stage, implantation material are wrapped up by cicatricial tissue, lead to filter unsmooth, filtration surgery Failure.

4. anti-glaucoma surgery eyeball massage

Brief introduction --- eyeball massage is one of postoperative measure for promoting effective avascular filtering bleb to be formed

Application method --- after glaucoma filtration surgery, for avascular filtering bleb function and the undesirable patient of form, by by profession instruction Experienced medical staff operates under slit-lamp, and patient's eyeball is advised to watch attentively upwards, then a thumb finger pulp is put in patient's art eye It is close to socket of the eye lower edge (being equivalent to 6 points), thumb oppresses lower part eyeball, and gently pushes up eyeball, may occur in which light Micro- swollen sense stops 2s after oppressing 2s, then is oppressed next time, 2~3 times/d, under each 15-20, continues 2-3 W.If eye There are the change such as apparent protuberance, disperse in the apparent avascular filtering blebs of drops and anterior chamber slightly shoals, you can stop massage.

There are the problem of --- if the healing of filtration internal orifice or scleral flap and sclera bed heal, massage be difficult gather effect, and Massage method and dynamics patient are difficult to grasp, and massage is improper to cause obliteratio camerae anterior, hyphema, filtration follicular rupture, iris embedding It fills in incision, the complication such as cut-out of limbus corneae splits.

Invention content

It is an object of the invention to for overcome the prior art be difficult to it is long-term, persistently maintain good postoperative aqueous humor filtering function Deficiency, provide a kind of new tool so that the aqueous humor of glaucoma filtration surgery filtration effect is more lasting, avoids patient's green light Eye multiple relapse, the pain performed the operation repeatedly.

To achieve the above object, the technical solution used in the present invention is：One kind is provided in glaucoma filtration operation The tool of implantation, which can be by carrying, and is sustained various anti-post-surgical scarring drugs, and after drug is finished, Injection of medicine can be repeatedly supplemented, while can be acted by patient's nature blink, promotes simultaneously maintenance function avascular filtering bleb from dynamic auxiliary Formation, and it is more convenient that postoperative avascular filtering bleb is safeguarded, so that the aqueous humor filtration effect of glaucoma filtration surgery is more Persistently, the permanently effective healing for avoiding aqueous humor filtration channel, ensures the long-term effect of glaucoma filtration surgery.

The structural scheme of the tool is as follows：

The tool is mainly made of 3 parts：1, shell：For loading and protecting the sustained release pouch in it, edge to have aperture, just Entire delayed release device is fixed in eyeball surface in suture；2, medicament slow release pouch：It, can be slow, micro with medicament slow release effect The drug carried in it is discharged, is located in shell.3, drug：The various drugs installed in medicament slow release pouch（Such as MMC, 5FU Deng, but not limited to this 2 kinds of drugs）, for preventing avascular filtering bleb from limiting to or increment package, prevent the healing of filtration channel.

Shell described in the tool is oval, flat, is about 16mm, wide about 13mm, central thickness thickness about 3mm, There are intensive small sircle hole, roundlet bore dia about 1mm, pitch of holes about 1mm, as sustained release in wall thickness about 0.5mm, outer wall major part region The drug outflow channel gone out【See Fig. 1, Fig. 2】, inner wall has appropriate radian without aperture, can well be attached at scleral surface【See figure 4, Fig. 5】.According to patient's eyeball size, corresponding radian, such as interior arc radius 12mm, 10mm different model are designed【See Fig. 5, Fig. 7】.Shell edge width about 2.0mm, inside there is 3 pairs（6）Symmetrical aperture, hole diameter about 1mm, is fixed for suture Delayed release device is in eyeball surface【See Fig. 1, Fig. 2, Fig. 4】.

Enclosure cavity described in the tool is divided into front and back two parts, is divided with a diaphragm plate with central cleft, preceding Cavity space is small, is about 4mm, rear cavity space is big, is about 8mm.The diaphragm plate is divided into front and back two layers, and there is 1 long and narrow crack in center, greatly Small about 0.7mm*3mm.Sustained release pouch mouth is penetrated by rear layer diaphragm plate crack, and is turned down outward, is pressed by front layer diaphragm plate, tabula It combines together with three layers of the sustained release cyst membrane for the fold being clamped among it for 2 layers before and after plate.Sustained release pouch is close to shell back cavity cavity wall, And through tabula crack and ante-chamber traffic【See Fig. 1, Fig. 3, Fig. 6, Fig. 7】.

The outer wall of shell described in the tool, back cavity has intensive small sircle hole, and roundlet bore dia about 1mm, pitch of holes is about 1mm, as the drug outflow channel being sustained out【See Fig. 1, Fig. 2】；Preceding cavity outer wall has 2 small sircle holes, diameter about 2mm, in hole The extraordinary rubber material filling of flexible and dereism, is inserted into superfine injection needle convenient for the later stage, supplements drug, and After syringe needle is extracted, pinprick perfection is self-closing【See Fig. 1, Fig. 2】.Ante-chamber space-closed is handed over except diaphragm plate crack is passed through with sustained release pouch It is logical outer, not with extraneous traffic【See Fig. 3, Fig. 6】.

Shell manufacture material described in the tool also requires to have certain other than having required good biocompatibility Hardness, pressure are not easy to collapse, will not more rupture, preferably to protect the medicament slow release pouch in it.And there is surface light It is sliding, hydrophobic, be not easy to be organized the characteristic of adhesion.Color of shell can be set according to the pharmaceutical properties installed in sustained release pouch as difference It sets.If drug need to be kept in dark place, then may be designed as dark-brown or black etc. can then design compared with dark colour if drug is without being protected from light For Transparent color or white etc. and sclera color-match.

Medicament slow release pouch described in the tool, pouch mouth combine together with shell diaphragm plate, and by diaphragm plate crack With shell ante-chamber traffic【See Fig. 6】, pouch volume is slightly larger than shell back cavity volume, and pouch outer surface is close to cavity wall after shell, After ensuring that shell slightly collapses, sustained release pouch will not rupture.

Medicament slow release pouch described in the tool is made of the cyst membrane with medicament slow release effect, it is desirable that drug release is extremely Slowly, ensure only micro sustained drug release, all release finishes when needing some months or even several years drug in pouch Between.Before coming into operation, it need to be tested, calculate its interior drug and take release required time entirely, with reference to this time, help to face Bed determines when to need to supplement drug again.Material requirements good toughness, is not easily broken.

Drug described in the tool is installed in medicament slow release pouch and shell ante-chamber, for preventing avascular filtering bleb limitation, group Adhesion package is knitted, is healed prevented also from scleral flap and sclera bed, to prevent the healing in entire filtration channel.Its drug can be MMC, All drugs that can inhibit cell division, prevent hyperblastosis, adhesion and package such as 5FU（But not limited to this 2 kinds of drugs）.Its Concentration, dosage form and dose must be debugged accurately before input, and be matched with the drug release efficiency of sustained release pouch, and calculate and mark Its interior drug all release required times are outpoured, so that when clinical judgment requires supplementation with drug.

All parameters such as all sizes, thickness, drug described in this specification can be adjusted in a certain range, no Absolute limit is parameter described above.

This tool also has the simple version to be：It is itself hardness, thickness, tough if a kind of medicament slow release cyst membrane can be researched and developed Property etc. can make following simplification close to sheathing material described in this tool, then this tool --- cancel medicament slow release capsule described in this tool Film, diaphragm plate and the intensive small sircle hole of rear cavity outer wall, other includes size, shape, drug etc. all parameter constants【See figure 9】, installation, application method are constant.

Description of the drawings

Fig. 1：Front perspective view；Fig. 2：Front appearance figure；Fig. 3：Front profile in plan；Fig. 4：Back appearance figure；Fig. 5：Outside side See figure；Fig. 6：Side sectional view（Vertical profile）；Fig. 7：Side sectional view（It is cross-sectional）；Fig. 8：Scheme of installation；Fig. 9：Simple version is just Face perspective view.

Specific implementation mode

Embodiments of the present invention are further described in conjunction with attached drawing：According to conventional Coffea arabiea method, fiber crops After liquor-saturated satisfaction, cuts off above temporo or bulbar conjunctiva, exposure top sclera after hemostasis is satisfied, make using corneoscleral junction as base above nose The scleral flap at bottom, size about 4mm*4mm（It, and can under corresponding bulbar conjunctiva between scleral flap and sclera bed according to clinical practice situation Certain time is handled with mitomycin C, then uses physiological saline continual rinsing）, lateral incision is made, scleral flap is overturn, exposure consolidates Film bed, cut-out trabecular meshwork, and the iris root of cut-out corresponding site reset scleral flap, cover cut-out Sclera bed after trabecular tissue sutures scleral flap with appropriate dynamics, and lateral incision injects appropriate physiological saline, maintain appropriate intraocular pressure and Anterior chamber depth.According to eyeball size, appropriate this tool of model is selected, and places this tool in correct position so that its front end （Ante-chamber one end）Close to scleral flap, therebetween apart from about 1.5mm, and body portion is then located at " superior rectus and musculus rectus lateralis "（Sclera Valve is located above temporo）Or " superior rectus and internal rectus muscle "（Scleral flap is located above nose）Between, by shell edge hole, suture is appropriate Needle number is fixedly secured the present apparatus in scleral surface.Bulbar conjunctiva is resetted, this tool and scleral flap are completely covered, is sutured, it is ensured that do not have Leakage.Operation terminates.Corresponding position is seen【Fig. 8】.

Drug in pouch, can exudation slow by release membranes, micro, prevent tissue adhesion, package, prevent avascular filtering bleb office Limit prevents scleral flap from healing with sclera bed, prevents the healing of filtration internal orifice, auxiliary aqueous humor from permanently flowing out, auxiliary remains good Avascular filtering bleb form and function.

Drug will not leak in shell ante-chamber, not influence the healing of conjunctival incision.

Housing back wall is non-porous, reduces influence of the drug to its lower sclera eubolism.

During eyeball autokinetic movement, upper eyelid can pass through the Gong of the intermittent slight compressing scleral flap periphery in apparatus body portion Film bed makes it generate micro collapse（Physical action）, be conducive to aqueous humor from the micro outflow of below scleral valve, effectively help to reduce eye Pressure, and prevent the adhesion of scleral flap and sclera bed, healing, be conducive to keep the unobstructed of filtration channel.

When needing ARTIFICIAL EYELID to massage, below oppression eyeball, the tissues such as eyelid, socket of the eye wall above eyeball will produce confrontation Force effect, oppresses the tool body portion, and then oppresses the sclera bed of scleral flap periphery, make its generate it is a certain amount of collapse, convenient for aqueous humor The effect of outflow, raising eyeball massage.

When all sustained release finishes the drug in sustained release pouch, and avascular filtering bleb has limitation, package tendency, eyeball massage can be passed through Auxiliary control intraocular pressure, the formation of promotion functions avascular filtering bleb when necessary can be by syringe needle separation of synechia, and can be used superfine One of in two rubber holes before syringe needle is inserted on cavity outer wall, appropriate amount of drug is re-injected, syringe needle is extracted Pinprick is self-closing afterwards.The filtration surgery for being on the verge of failure can be saved.

Claims

1. a kind of tool for the prevention of postoperative scarring being implanted into glaucoma filtration operation, it is characterised in that it is mainly by 3 Part forms：（1）Shell,（2）Medicament slow release pouch,（3）Drug.

2. shell as claimed in claim 1, which is characterized in that its internal cavities is divided into front and back 2 parts, has band to split by centre The diaphragm plate of gap separates, and ante-chamber closing, only by tabula crack and sustained release pouch traffic, but preceding cavity outer wall has silica gel closed small Hole can be used for supplementing drug, and rear cavity outer wall has a large amount of apertures, and interior to contain medicament slow release pouch, entire inner wall is non-porous, and there have to be appropriate Radian is affixed with sclera, and shell edge has aperture, and entire delayed release device is fixed in eyeball surface convenient for suture.

3. medicament slow release pouch as claimed in claim 1, which is characterized in that there is medicament slow release effect, slow, micro can release The drug carried in it is put, is located in shell back cavity, pouch mouth is merged with shell tabula, passes through tabula crack with shell ante-chamber Communicating.

4. drug as claimed in claim 1, which is characterized in that there is antimetabolic, inhibit cell division, prevent post-surgical scarring Effect（Such as MMC, 5FU, but not limited to this 2 kinds of drugs）, install in medicament slow release pouch, with slow speed and small Amount, release prevents tissue adhesion and the formation of tissue encapsulation to outside pouch, prevents the healing of filtration channel.

5. implanting instrument as claimed in claim 1, which is characterized in that medicament slow release can not only be played the role of, can be mended repeatedly Drug is filled, shell can also safeguard the normal morphology of postoperative avascular filtering bleb automatically with eyeball and eyelid movement（Physical action）, together When postoperative ARTIFICIAL EYELID's massage therapy can be made more efficient（Physical action）.

6. all parameters such as all sizes, thickness, drug described in specification can be adjusted in a certain range, not absolutely It is limited to parameter described above.

7. a tool also has the simple version to be：Select a kind of medicament slow release cyst membrane, itself hardness, thickness, toughness etc. close The sheathing material described in this tool, then this tool can make following simplification --- cancel medicament slow release cyst membrane, tabula described in this tool Plate and the intensive small sircle hole of rear cavity outer wall, other includes size, shape, drug etc. all parameter constants, installation, user Method is constant, also in this scope of patent protection.