CN109692072A - A kind of epichoroidal space pressurization hydrogel sphere bag apparatus for rhegmatogenous detachment of retina - Google Patents
A kind of epichoroidal space pressurization hydrogel sphere bag apparatus for rhegmatogenous detachment of retina Download PDFInfo
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- CN109692072A CN109692072A CN201910018023.8A CN201910018023A CN109692072A CN 109692072 A CN109692072 A CN 109692072A CN 201910018023 A CN201910018023 A CN 201910018023A CN 109692072 A CN109692072 A CN 109692072A
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- sacculus
- hydrogel
- injection needle
- epichoroidal space
- retina
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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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00727—Apparatus for retinal reattachment
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
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- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention discloses a kind of epichoroidal space pressurization hydrogel sphere bag apparatus for rhegmatogenous detachment of retina, by hydrogel sacculus, injection needle and filler composition, hydrogel sacculus is by balloon body, head side cecum sheath and tail end self-closing valve are constituted, shape is the oblate capsule of unilateral blind pipe sample when not full, the cecum sheath tube wall of sacculus head side is than balloon body wall thickness, form the set sheath at tight injection needle tip, there is unidirectional self-closing diaphragm in balloon body, sacculus major diameter is divided into multiple compartments, sacculus caudal is connected with the dual self-closing valve of hydrogel, its internal diameter of the pipeline can be put into epichoroidal space puncture needle core, after injection needle exits, lumen is because of the elastical retraction of tube wall itself and the double action tight closing of corresponding external elastic beam ring, so that sacculus content will not leak out；There is scale on injection needle.The length, width and height of sacculus pressurization ridge of the present invention are stably and controllable adjustable, and the soak time of balloon wall determines the retention time of ridge, and inter-individual difference is small, and the success rate of operation can be improved.
Description
Technical field
The present invention relates to a kind of surgical instruments that ophthalmology retinal disease in clinical medicine uses, and are especially used for hole source property
The epichoroidal space pressurization hydrogel sphere bag apparatus of detachment of retina.
Background technique
Rhegmatogenous detachment of retina is a kind of most common blinding retinal disease, which is due to retina neural
There is ceasma in epithelium, and liquid enters the separation under retina and leading to neuroepithelium of retina and pigment epithelium in vitreum.Suffer from
Person male is about 3: 2 more than women, and majority is 30 years old or more adult, and difference between right and left eyes, eyes disease incidence is about patient
The 15% of sum.It is apt to occur in myopia, especially high myopia.
The basic principle for treating rhegmatogenous detachment of retina is close the break, promotes absorption and the retina of subretinal fluid
Calm down, can be generally divided into sclera external pressure and operation on vitreous.
Segmental scleral buckling is the most classical and common art formula of rhegmatogenous detachment of retina, basic operation are as follows: overturning eye
The corresponding eyeball surface of ball exposure retinal hole, the external pressurized object of silica gel or silicon sponge material is sutured through sqclerotal layer, makes office
Portion's wall of eyeball invagination, choroid are bonded with retina, and form adhesion around ceasma using freezing or laser reactive to reach
To the purpose of close the break.Since wall of eyeball keeps complete, eye inner tissue is disturbed it is small, few intercurrent disease and some patientss still
For one of preferred embodiment.But the operation overturns eyeball due to that need to pull muscle, and feeling of pain is obvious in art, is likely to occur eyeball compression reflex
Cause heartbeat slow down even all standing；Myotasis damage or postoperative cicatricial adhesion can influence eye movement and lead to diplopia in art；
It is postoperative due to can lead to astigmatism, metamorphopsia to cornea and retinal morphology influence, influence chorioretinal blood fortune and outer
Object infection of pressurizeing is discharged, and needs complication and the adverse reaction such as operation wound clearing taking-up again.
Operation on vitreous be after the proliferation drawing for removing vitreum and retina within filler press promote ceasma
The method for being closed reattachment of retina, currently used intraocular long-acting filler have expanding gas, silicone oil, are that specific gravity is lighter than water
Substance, it is bad for the press healing ability of lower section retinal hole, become the difficult point of such operation.
Emerging epichoroidal space pressurization art formula is the epichoroidal space around ceasma by the positioning to retinal hole
The pressurization ridge that the long-acting viscoelastic agent such as cross-linked-hyaluronic acid (Hai Lefu) forms protuberance is injected, retina is caused at retinal hole
Choroidal abutting, closing, American-European clinical application have proven to this method can provide enough pressure on top surface and success rate and
Smaller to ocular nerve, myotasis, wound is small, and after-operation response is smaller, smaller to intraocular disturbance；And hyaluronic acid human body
Affinity is strong, and rejection is smaller, and variety classes filler can be by dividing 1 week-June according to different crosslinking methods within the eye
Solution.The method can avoid above-mentioned all complication caused by sclera external pressure object, and postoperative edema pain is considerably less than conventional method；
Epichoroidal space pressurization joint operation on vitreous can then carry out satisfied supplement press to lower section ceasma, improve its success rate.
But pressurization ridge will be formed after current epichoroidal space hydrogel injection in a manner of free disperse, shape and
Height be difficult to control, the selling at exorbitant prices of medical cross-linked hyaluronic acid and can injected slurry volume it is limited, be formed by pressurization ridge filler
The problems such as absorption rate individual difference is big.It requires further improvement to improve controllability and success rate of operation.
Fig. 1 is figure compared with epichoroidal space pressurization art presses Surgical Operation with traditional sclera external, separates sclera with blunt nosed needle
Potential lacuna -- epichoroidal space between choroid injects long-acting hyaluronic acid sodium gel and causes arteries and veins after reaching ceasma position
The protuberance of network film forms pressurization ridge, wherein (a) are as follows: silicon sponge is sutured in eyeball surface figure by traditional sclera external pressure, (b) are as follows:
Epichoroidal space pressurizes sacculus between sclera and choroid layer, (c) are as follows: clinical application epichoroidal space Pressurized pinhead.This
The controllability of separation process and final form is poor, and once pressurization ridge position deviates, and will be unable to effectively adjust.It is long-acting
Sodium Hyaluronate is expensive at present, and soak time is partially short, and soak time difference is big between individual, therefore epichoroidal space pressurizes
Art requires further improvement, to improve its controllability and stability.
Summary of the invention
The object of the present invention is to provide a kind of epichoroidal space pressurization hydrogel sphere capsules for rhegmatogenous detachment of retina
Device, sacculus are in normal eyes in eyeball using good biocompatibility, absorbable and adjustable absorption rate hydrogel material
It is implanted into epichoroidal space in the case where position, and inject filler to make balloon inflation, is pressed using the volume mechanical after balloon dilation
Retinal hole, so that scar packet outside the eyeball caused by the excessive drawing of eyeball muscle, pressurization object be reduced or avoided in operation
It wraps up in and deviates from caused by infecting or rejecting, to the amount of eyeball extruding, good control padding and the height for the ridge that pressurizes, reach micro-
Wound, the safe and effective effect for pressing ceasma, calming down retina.
A kind of epichoroidal space pressurization hydrogel sphere bag apparatus for rhegmatogenous detachment of retina of the present invention, by hydrogel
Sacculus, injection needle and filler composition.
Hydrogel balloon structure: it is made of balloon body, head side cecum sheath and tail end self-closing valve.It is conventional when not full
Monnolithic case is the unilateral oblate capsule of blind pipe sample, caliber 0.8-1.0mm, when completely full, long 10-60mm, wide 8-12mm high 4-
8mm, wall thickness are 100-1000 microns.
The form of above-mentioned numerical value and the object that pressurizes in practical applications can by it is full completely whether adjust, can also basis
Individuation customization, 3D printing is embodied.When carrying out pad pressure to posterior scleral staphyloma, it is made into the circle of fitting eyeball staphyloma radian
Plate-like water pocket；When carrying out cerclage, it is made into 360 DEG C of shape rings.
The cecum sheath tube wall of hydrogel sacculus head side compared with balloon body wall thickness, cecum sheath tube wall with a thickness of 0.3-0.5mm,
The set sheath spline structure at tight injection needle tip is formed, it is olivary casing that a head end is formed when wrapping up injection needle
The smooth passivity tissue separated structure of needle-like can effectively protect cyst wall and epichoroidal space week during epichoroidal space separation
Tissue is enclosed, it is safely controllable；After after injection fillers object, sheath head with balloon expandable, loosen the package of syringe needle by expansion naturally, will not hinder
Injection needle after the completion of injection is hindered to exit.
There is unidirectional self-closing diaphragm in balloon body, is divided into multiple compartments for sacculus major diameter is equidistant, is injected with injection needle
Filler is full of one of them or several compartments, keeps sacculus pressurization length segmentation adjustable.
Hydrogel sacculus caudal is connected with tail end self-closing valve, and the internal diameter of the pipeline maximum tension diameter 0.6mm of tail end self-closing valve can
It is put into epichoroidal space puncture needle core (25G caliber), external elastic beam ring covers outside tail end self-closing valve.It is exited in injection needle
Afterwards, the lumen of balloon body is because of the elastical retraction of tube wall itself and the double action tight closing of corresponding external elastic beam ring,
So that the content of balloon body will not leak out.
Sacculus material: for good, soft, lubrication the absorbable hydrogel material (PVA etc.) of biocompatibility, soak time
Can by the molecule of the material of balloon wall constitute and thickness adjust, make its within the eye retention time at 2 months to the several years.Above-mentioned water
Gel ball capsule material matter includes: water-soluble macromolecule (native starch, natural plant gum, animal glue (casein), chitin and sea
Soluble derivative, carboxymethyl starch, acetic starch, hydroxymethyl cellulose, carboxymethyl cellulose, the polyvinylpyrrolidine of alginic acid
Ketone, polyvinyl alcohol, 2- acrylamide-2-methyl propane sulfonic, 2-hydroxyethyl methacry-late, acrylic acid, methacrylic acid, first
Base acrylate, 4- acryloyl morpholine, acrylamide, vinylpyrrolidone, polyethylene acrylate, acrylic acid 3- sulfonic acid propyl ester
Sylvite, polyvinyl alcohol, N,N-DMAA, (3- acrylamide propyl) trimethyl ammonium chloride, 2- acrylyl oxy-ethyl
Trimethyl ammonium chloride one or any of several, or be made of the monomer or cross-linking products of above-mentioned material.
Syringe needle overall length 37mm is penetrated, shape is the arc of identical wall of eyeball radian, and tip is smooth indenting ball, is had on shank
Scale does not need the olive forming head of front end, only needs to determine position of the syringe needle when filler injects in different compartments outside eye
The smooth indenting ball in tip is formed,.
The intracapsular filler of hydrogel sphere is any one in air, physiological saline/BSS or common sodium hyaluronate
Kind, it can according to need selection, the controllability and retention time of Sodium Hyaluronate are best.
In use, filler injection plain head is first passed through tail end self-closing valve and balloon body inner septum, it is inserted into head end set
Then intrathecal tight carries out the separation of epichoroidal space by scleral incision, inject content when reaching the position of quasi- pressurization
Object fills the length of hydrogel sacculus to needs, and adjusts hydrogel balloon position to backed off after random injection needle is satisfied with, and makes
Hydrogel sacculus is retained in epichoroidal space, absorbs after a set time.
The present invention is by a kind of temporary epichoroidal space pressurizing device come more controllable more minimally invasive formation epichoroidal space
Pressurization ridge, the set sheath spline structure at injection needle tip can effective protection cyst wall and train of thought during epichoroidal space separates
Epistege surrounding tissue, it is safely controllable；Balloon body has unidirectional self-closing diaphragm to keep sacculus pressurization length segmentation adjustable, and lumen is because of pipe
The double action tight closing of the elastical retraction of wall itself and corresponding external elastic beam ring, so that the content of hydrogel sacculus
It will not leak out, avoid or reduce the relevant complication of external pressurized object and risk, increase success rate of operation, reduce patients surgery pain
Bitter, shortening operating time, reduces operation cost/expense, improves such disease prognosis.The difference of hydrogel sphere capsule volume and size
Parameter determines that the length, width and height of pressurization ridge are stably and controllable, and the soak time of balloon wall determines the retention time of ridge, poor between individual
It is different small.
Detailed description of the invention
Fig. 1 is figure compared with epichoroidal space pressurization art presses Surgical Operation with traditional sclera external；A is sclera external pressure, often
It is sewn to eyeball surface with silica gel, silicon sponge, makes eyeball deformation invagination, the operation of suture and the external pressurized object of eyeball surface itself
A series of complication can be brought；B is epichoroidal space pressurization, and pressurization level is in eyeball inner face, without overturning eyeball suture,
Avoid traditional sclera external pressure some serious problems of bring；C is the olive shape head end of epichoroidal space Pressurized pinhead upper
When chamber separation and operation safely, effectively.
Fig. 2 is structure chart when epichoroidal space of the present invention pressurization sacculus is full；Wherein a be front view, b side view, c cut
Face figure；
Fig. 3 is structure chart when epichoroidal space of the present invention pressurization sacculus is not full；
Fig. 4 epichoroidal space pressurization sacculus application method schematic diagram.Its a is sectional view, and b is injection connection signal face figure.
Specific embodiment
The detailed description of a step is done to the present invention with reference to the accompanying drawing.The given examples are served only to explain the present invention, not uses
In limiting the scope of the invention.
Embodiment 1
As shown in Figure 2 and Figure 4, the present invention is made of hydrogel sacculus 1, injection needle 8 and filler 2, hydrogel sacculus 1
It is made of balloon body, head side cecum sheath 3, tail end self-closing valve 5 and external elastic beam ring 6, when not full, monnolithic case is single
The oblate capsule of side blind pipe sample, the tube wall of head side cecum sheath 3 form the tip sleeve of tight injection needle 8 than balloon body wall thickness
Sheath spline structure, effective protection cyst wall and epichoroidal space surrounding tissue during epichoroidal space separation；It is filled in injection
After object 2, the sheath head of head side cecum sheath 3 is expanded with hydrogel sacculus 1, and the package loosened to injection needle 8 is unfolded naturally；Sacculus master
There is unidirectional self-closing diaphragm 4 in vivo, is divided into multiple compartments for balloon body major diameter is equidistant, filler 2 is connected to note by hose 7
Syringe needle 8 is penetrated, filler 2 is full of by one of them or several compartments by injection needle 8, makes the pressurization length point of hydrogel sacculus 1
Section is adjustable；The caudal of hydrogel sacculus 1 is connected with tail end self-closing valve 5, and the internal diameter of the pipeline of tail end self-closing valve 5 can be put into epichoroidal space
Puncture needle core, 6 sets of external elastic beam ring is in 5 outside of tail end self-closing valve, after injection needle 8 exits, the lumen of hydrogel sacculus 1 because
The elastical retraction of tube wall itself and the double action tight closing of external elastic beam ring 6, so that the filler 2 of hydrogel sacculus 1
It will not leak out；8 overall length 37mm of injection needle, shape are the arc of identical wall of eyeball radian, and tip is smooth indenting ball, shank
On have scale, so as to outside eye determine syringe needle different compartments 4 inject filler 2 position, the filler 2 of hydrogel sacculus 1
For air, physiological saline, BSS or sodium hyaluronate.Fig. 3 is structure chart when epichoroidal space pressurization sacculus is not full.
There is unidirectional self-closing diaphragm 4 in balloon body, is divided into multiple compartments for balloon body major diameter is equidistant, uses injection needle
Injection fillers object is full of one of them or several compartments, keeps the pressurization of hydrogel sacculus 1 length segmentation adjustable.Use behaviour of the invention
Make step:
(1) conjunctiva of retinal hole quadrant is cut in art, exposure sclera utilizes indirect ophthalmoscope or surgical operation microscope
It determines ceasma position and marks.
(2) make the 1-1.5mm meridian apart from corneal limbus 4mm to holostrome scleral incision to expose choroid.
(3) one 1-2 millimeters of pocket, and the preset suture of indwelling are created, for introducing conduit on choroid.
(4) by hydrogel sphere cuff on epichoroidal space puncture needle, hydrogel sacculus itself can play Olivary head at this time
Injection needle 8 with casing is placed in epichoroidal space by pocket by effect, and process of passing through tunnel is put into target position.
(5) after reaching target position, shank high scale is observed when moving back, after reaching balloon body target position, through injecting
Syringe needle 8 is squeezed into balloon body tamps object 2, observes pressurization ridge height after making a compartment and whether width is suitable, if not
It is suitable then adjust syringe needle to second compartment, filler is played in compartment, unidirectionally self-closing diaphragm is self-closing for first compartment at this time.
(6) indwelling of hydrogel sacculus determines ceasma closed state in epichoroidal space, such as not repeatable enough 4-5 step, position
Setting undesirable can adjust hydrogel balloon position to satisfaction in epichoroidal space.
Claims (6)
- The hydrogel sphere bag apparatus 1. a kind of epichoroidal space for rhegmatogenous detachment of retina pressurizes, it is characterised in that: by water Gel sacculus, injection needle and filler composition, hydrogel sacculus is by balloon body, head side cecum sheath, tail end self-closing valve and outer It encloses elastic beam ring to constitute, the cecum sheath tube wall of sacculus head side forms tight injection needle tip than balloon body wall thickness Sheath spline structure is covered, it is the smooth passivity tissue separated structure of olivary casing needle-like that a head end is formed when wrapping up injection needle, Effective protection cyst wall and epichoroidal space adjacent tissue during epichoroidal space separation；After injection fillers object, head side The sheath head of cecum sheath with hydrogel balloon expandable, loosen the package of injection needle by expansion naturally；Have in balloon body unidirectional self-closing Diaphragm is divided into multiple compartments for balloon body major diameter is equidistant, with injection needle injection fillers object full of one of them or it is several Compartment keeps hydrogel sacculus pressurization length segmentation adjustable；Hydrogel sacculus caudal is connected with tail end self-closing valve, the self-closing valve pipeline of tail end Internal diameter can be put into epichoroidal space puncture needle core, and external elastic beam ring covers outside tail end self-closing valve, after injection needle exits, ball The lumen of capsule main body is in the elastical retraction of tube wall itself and the double action tight closing of external elastic beam ring, and sacculus content is not It can leak out；Injection needle shape is the arc of identical wall of eyeball radian, and tip is smooth indenting ball, has scale on shank, really Determine position of the injection needle when filler injects in different compartments, the filler of hydrogel sacculus is air, physiological saline, BSS Or sodium hyaluronate.
- 2. a kind of epichoroidal space pressurization hydrogel sphere capsule dress for rhegmatogenous detachment of retina as described in claim 1 It sets, it is characterised in that: hydrogel sphere capsule material matter is good, soft, lubrication the absorbable hydrogel material of biocompatibility, sacculus The molecule of main body wall material is constituted and thickness is adjustable.
- 3. a kind of epichoroidal space pressurization hydrogel sphere capsule dress for rhegmatogenous detachment of retina as described in claim 1 It sets, it is characterised in that: hydrogel sacculus caliber is 0.8-1.0mm, when completely full, long 10-60mm, wide 8-12mm, high 4- 8mm, balloon body wall thickness are 100-1000 microns.
- 4. a kind of epichoroidal space pressurization hydrogel sphere capsule dress for rhegmatogenous detachment of retina as described in claim 1 It sets, it is characterised in that: cecum sheath pipe thickness is 0.3-0.5mm.
- 5. a kind of epichoroidal space pressurization hydrogel sphere capsule dress for rhegmatogenous detachment of retina as described in claim 1 It sets, it is characterised in that: tail end self-closing valve internal diameter of the pipeline maximum tension diameter is 0.6mm.
- 6. a kind of epichoroidal space pressurization hydrogel sphere capsule dress for rhegmatogenous detachment of retina as described in claim 1 It sets, it is characterised in that: hydrogel sacculus is by when not full, monnolithic case is the oblate capsule of unilateral blind pipe sample, or to posterior scleral When staphyloma carries out pad pressure, hydrogel sacculus is made into the discoid water pocket of fitting eyeball staphyloma radian；Or when carrying out cerclage, Hydrogel sacculus is made into 360 DEG C of shape rings.
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| CN201910018023.8A CN109692072B (en) | 2019-01-09 | 2019-01-09 | A suprachoroidal pressurized hydrogel balloon device for rhegmatogenous retinal detachment |
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| CN201910018023.8A CN109692072B (en) | 2019-01-09 | 2019-01-09 | A suprachoroidal pressurized hydrogel balloon device for rhegmatogenous retinal detachment |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110302005A (en) * | 2019-07-16 | 2019-10-08 | 上海交通大学医学院附属第九人民医院 | A kind of posterior scleral quantifies pressurizing block and its application method |
| CN110859702A (en) * | 2019-11-21 | 2020-03-06 | 广州卫视博生物科技有限公司 | Folding top pressing balloon structure |
| CN111808800A (en) * | 2020-07-20 | 2020-10-23 | 中南大学湘雅二医院 | In vitro induced immunosuppressive myeloid suppressor cell and its preparation and application |
| CN112807149A (en) * | 2021-02-02 | 2021-05-18 | 超目科技(北京)有限公司 | Posterior scleral crosslinking device and use method thereof |
| WO2022127763A1 (en) * | 2020-12-14 | 2022-06-23 | 中国人民解放军总医院 | Nailing type retinal hole sealer and implant |
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