EP0515489A1 - Valve anti-glaucome - Google Patents

Valve anti-glaucome

Info

Publication number
EP0515489A1
EP0515489A1 EP19910904448 EP91904448A EP0515489A1 EP 0515489 A1 EP0515489 A1 EP 0515489A1 EP 19910904448 EP19910904448 EP 19910904448 EP 91904448 A EP91904448 A EP 91904448A EP 0515489 A1 EP0515489 A1 EP 0515489A1
Authority
EP
European Patent Office
Prior art keywords
tube
eye
section
plate
glaucoma
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19910904448
Other languages
German (de)
English (en)
Inventor
Jan-Ove Persson
Per-Arne GRANSTRÖM
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Atos Medical AB
Original Assignee
Atos Medical AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Atos Medical AB filed Critical Atos Medical AB
Publication of EP0515489A1 publication Critical patent/EP0515489A1/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment

Definitions

  • the invention relates to a glaucoma valve, comprisin an elongated tube and a curved plate attached to one end the tube for connecting the interior of the eye to the su rounding tissue and draining a fluid from the interior of the eye to the surrounding tissue.
  • Glaucoma is an eye disease which, if not treated, gr dually leads to loss of vision.
  • the loss of vision is cau sed by the death and disappearance of the nerve fibers lo cated in the optical nerve and which normally transmit th information of vision from the retina of the eye to the v sual cortex in the brain.
  • the loss of the optical nerve f bers in connection with glaucoma is in turn caused by an abnormally high intraocular pressure in the eye.
  • aqueous humor In the interior of the eye there is constantly produ ced the so called aqueous humor, a clear liquid mainly co sisting of water.
  • the aqueus humor which is produced in the ciliary body of the eye behind the iris, flows throug the pupill towards the so called anterior chamber of the eye where the aqueous humor leaves the eye partly via a drainage system consisting of a number of fine pores, cal led the trabecular meshwork, partly via Schlemm's channel as well as the aqueous veins.
  • a balance between the production of aqueous humor and the outflow through the drainage system that causes the hy ⁇ drostatic pressure to reach a sufficiently high level in order to expand the tissues of the eye without injuring them. In connection with glaucoma this balance has been disturbed, usually caused by a too high flow resistance through the trabecular meshwork increasing whereby the pressure in the eye.
  • the treatment of glaucoma aims to lower the pressure of the liquid in the eye to a normal level. This can ofte be accomplished by means of different types of medication In several cases, however, medication only is not suffi ⁇ cient and a hole is then made through which aqueous humor can leak from the eye. Thus, there is accomplished an arti ficial drainage with a lowering of the fluid pressure of the eye as a consequense. The hole in the wall of the eye which is accomplished by surgery unfortunately often fills up again increasing the pressure. In order to secure a per manent drainage of aqueous humor from the eye some kind of valve or drainage tube is sometimes used which is inserted (implanted) into the eye by operation. The drainage device which are commercially available today have som disadvanta ges which are the cause of their rather limited use.
  • these drainage devices or so called glaucoma valves consist of a thin tube which is placed with one end in the anterior chamber and the other end on the surface o the sclerotic layer under what is called Tenon's capsule far up under the upper eyelid.
  • a plate or a so called sealant connected which is made of some plastic material.
  • the purpose of the plate is to increase the liquid absorbing surface where the outflo ⁇ wing aqueous humor meats the tissues on the outside of the eye.
  • some kind of pressure regulating valve device is connected to the upper end of the tube in order to accomplish a certain low back pressure in the tube thus preventing the pressure level in the eye from falling to zero.
  • Glaucoma valves available today exhibit among other things the following drawbacks:
  • the flow of aqueous humor often becomes to heavy and the pres ⁇ sure in the eye to low. This results in the bulging of the lense and the iris of the eye towards the back of the cor ⁇ nea and thereby the damaging of both the lense and the cornea. Furthermore, the too low pressure in the eye can cause the loosening of the choroid coat as it is called a the back of the eye with visual impairement as a conse ⁇ quense.
  • the scar tissue which is always formed around the up per end of the drainage tube and around the plate is in many cases so dense that it causes a too high flow resis ⁇ tance for the aqueous humor flowing out at the upper mout of the tube.
  • the intended lowering of the pressure in the eye is then not sufficient.
  • the liquid absorbing surface can be increased either by a larger surface of the implant or by a later implantation an additional valve.
  • the ope rating trauma increases more than if only one opertion an a smaller implant would have been enough.
  • the tubes of the now commercially available glaucoma valves have an outer diameter which is comparatively larg and they are also comparatively stiff so as to facilitate the implantation, usually the tube is implanted in such a way that it will for a certain distance run inside the sclerotic layer between its lamellas. If the tube is thic it will exert pressure on the tissue and thereby cause th gradual disapperance of sclerotic tissue. This sometimes results in the tube lying exposed on the surface of the eye.
  • One object of the present invention is to essentially overcome the above described problem with a glaucoma valve which in addition is very simple in its construction.
  • An other object of the invention is to provide a glau coma valve which by its shape is easy to implant and with which the implantation implies a low risk of damage. After the implantation the risk of inflammation, rejection or other damages shall also be low.
  • FIG. la is a cross sectional view of a healthy eye
  • FIG. lb is a cross sectional view of a part of a helthy eye in an enlarged scale
  • FIG. 2 is a cross sectional view of an eye with an im planted valve according to the invention
  • FIG. 3 is a side view of a part of a valve according to the invention.
  • FIG. 4 is a plan view from above of a part of a valve according to the invention.
  • FIG. 5 is a longitudinal section view of a tube accor ding to the invention
  • FIG. 6 is a cross sectional view taken along a line A A of the tube of FIG. 5.
  • FIG. la and lb show a helthy eye.
  • the eye consists of an almost spherical capsule with the cornea 1 in its front and the sclerotic layer 2 in its back. Both the cornea and the sclerotic layer are built up by rather solid tissues which are expanded by the liquid pressure from the interi of the eye. In this way the eye keeps its shape.
  • a short distance behind the cornea is the iris 3 located and behi this the lense 4.
  • the latter is kept in place by very thi fibers, the zonule of Zinn 5, in the ciliary body 6.
  • the musculature in the ciliary body can influence the tension in the zonula fibers and thus the shape of the lense.
  • the c liary body also has another function, that is to produce the aqueous humor, as it is called, which occurs in speci cells on the surface of the ciliary body (in the so calle ciliary epithelium) .
  • the produced aqueous humor moves for ward, bypass the lense and out through the pupil 7 to the anterior chamber 8 which is the liquid containing space s tuated between the back surface of the cornea and the fro surfaces of the iris/lense.
  • the aqueous humor leaves the anterior chamber of the eye via several very fine pores, jointly designated the trabecular meshwork 9, FIG. lb.
  • the vitreous body 1 Behind the lense of the eye lies the vitreous body 1 a clear jelly like liquid. Between the vitreous body and the sclerotic layer lies the retina 13 and the choroid co 14. From the retina emanate those nerve fibers which jointly form the optical nerve 15 and which transmit visu information from the eye to the brain. Within the front part of the eye the sclerotic layer is covered by a rela ⁇ tively thin, loosely constructed opaque film, what is cal ⁇ led conjuctiva 16. The conjuctiva does not cover the scle ⁇ rotic layer on the back of the eye but curves forward at 1 and instead covers the inside 18 of the eyelid.
  • a glaucoma valve From an incision in the surface of the sclerotic layer, at 20, a channel 21 is prepared withi the sclerotic connective tissue opening into the anterior chamber 8 of the eye. Into the channel is introduced a fin tube 22, one end thereof opening in the chamber of the eye The other end of the tube is connected to a plate 23 which in the embodiment shown is constructed of PMMA and in whic the tube ends. The plate will lie on the surface of the ey (the sclerotic layer 2) under Tenon's capsule 19. The plat increases the liquid absorbing surface of the surrounding tissue where the aqueous humor flows out at the upper end of the tube.
  • the plate 23 is more clearly evident.
  • the plate is cir- cular, slightly vaulted and constructed of PMMA.
  • Other em ⁇ bodiments and materials are, however, also possible.
  • both the tube and the plate can be constructed of the same material (silicon rubber) and then in one piece.
  • the plate is preferrably heparinized and coated with layer of titanium.
  • the thickness of the titanium layer should lay within the interval 200-1000 A (200*10" 10 m- 1000*" 10 m) .
  • the purpose of the surface coating with hepar or titanium is too drastically reduce the tissue reaction around the plate always arising from implantation of fo ⁇ reign material on the surface of the eye and which causes scar formation and thus detoriated absorption of the aqueous humor. By this measure a sufficient amount of aqueous humor flow is secured without the necessity of su a large surface of the plate.
  • the tube has inner diameter i less than that of prior art glaucoma valves.
  • the inner diameter is only 0.20 mm.
  • the inner diameter should lie within the interval 0.15-0. mm and the inner diameter should not exceed 0.25 mm.
  • the length of the glaucoma valve according to the invention will lie within the inte val 15-20 mm. Together with the chosen inner diameter thi length results in a desired restriction effect of the valve. If another length is chosen the inner diameter is adapted in order to keep the desired contracting effect.
  • a length of 10 mm a suitable inner diameter is about 0.18 mm.
  • the restriction effect is available immediately after the implantation. According to the invention only a part the tube has to be constructed with the above specified d mensions in order to obtain the desired restriction effec This part of the tube, at least, has a closed interior en velope surface so that no abduction of aqueous humor will occur there. The remaining parts of the tube are construc ted with greater dimensions in order not to contribute to the restriction.
  • the desired restriction effect correspond to a counter pressure for the flow of aqueous humor of between 1 mm Hg and 15 mm Hg. At a high counter pressure from the tissue which surrounds the plate 23 the counter pressure in that part should be lower.
  • the plate 23 is constructed with an inner channel which in one end recieves the tube and the other end ends in the surface of the plate, for example in the center of the plate.
  • the channel comprises a part with the above men tioned dimensions achieving the desired restricting effect.
  • the channel is spiral shaped and ends in the center of the plate and in another alternative embodi ⁇ ment the channel is constructed as a coil of desired lengt with several parts running parallell.
  • the lower end is bevelled.
  • the tube is implanted with the lower be ⁇ velled edge positioned so that the opening will point obliquely ahead downwards towards the center of the cornea. This will eliminate the risk of obstructing the lower ope ⁇ ning of the tube by the iris, if this should contact the lower end of the tube.
  • FIG.6 which is a cross section along the line A- of FIG. 5 , another feature of the tube is shown. Since the cross section of the tube is elliptic several important characteristics are obtained.
  • the sclerotic layer is con ⁇ structed of several thin lamella which are arranged in pa ⁇ rallell both between themselves and relative to the surfac of the sclerotic layer.
  • the individual lamella have co pa- ratively high strength but are loosely connected with each other.
  • This construction of the sclerotic layer results in an always flat cross section of the channel prepared for implantation.
  • An elliptic tube according to the invention adheres thoroughly against the channel in the sclerotic layer in order to obtain a good sealing between the tube and the channel.
  • a leakage at the side of the tube re sults in an uncontrolled outflow of aqueous humor and thu a too low pressure in the eye with the risk of permanent damages to the eye as a consequense.
  • An additional advantage of a tube elliptic in cross section is that the tube becomes more rigid compared with tube circular in cross section and is thus more easier to introduce in the channel prepared.
  • a good sealing between the tube and the sclerotic layer can also be achieved with a circular tube but in or der to obtain a good sealing the tube will then excert a comparatively high pressure towards the outer and inner surfaces of the sclerotic layer.
  • the increased mechanical pressure which is excerted by a circular tube on the scle rotic tissue leads to a gradual breakdown of the tissue.
  • the result is that until now available circular tubes of glaucoma valves sometimes are forced up and remain naked the front surface of the eye. This risk is considerably lesser with a tube according to the invention.
  • the risk o irritating the surrounding tissue is also considerably re swiped both in connection with the implantation and after ⁇ wards during the life span of the implantate.
  • the inside contoure of the tube is circular in the embodiment shown but this shape can be varied within the scope of the inve tion.

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Devices For Medical Bathing And Washing (AREA)

Abstract

L'invention se rapporte à une valve anti-glaucome, qui comprend un tube allongé (22) et une plaquette incurvée (23) fixée à l'une des extrémités dudit tube (22), en vue de relier l'intérieur de l'oeil aux tissus circonvoisins et de drainer un flux de liquide occulaire de l'intérieur de l'oeil vers ces tissus circonvoisins. Un canal contenu dans le tube et dans la plaquette est conçue avec une section présentant une surface d'enveloppe intérieure fermée, le diamètre interne et la longueur de cette section étant ajustés de façon à obtenir la restriction désirée du flux de liquide occulaire.
EP19910904448 1990-02-12 1991-02-12 Valve anti-glaucome Pending EP0515489A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9000491 1990-02-12
SE9000491A SE9000491L (sv) 1990-02-12 1990-02-12 Glaukomventil

Publications (1)

Publication Number Publication Date
EP0515489A1 true EP0515489A1 (fr) 1992-12-02

Family

ID=20378527

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19910904448 Pending EP0515489A1 (fr) 1990-02-12 1991-02-12 Valve anti-glaucome

Country Status (3)

Country Link
EP (1) EP0515489A1 (fr)
SE (1) SE9000491L (fr)
WO (1) WO1991012046A1 (fr)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5476445A (en) * 1990-05-31 1995-12-19 Iovision, Inc. Glaucoma implant with a temporary flow restricting seal
US5178604A (en) * 1990-05-31 1993-01-12 Iovision, Inc. Glaucoma implant
US5370641A (en) * 1992-05-22 1994-12-06 O'donnell, Jr.; Francis E. Laser trabeculodissection
WO1994013234A1 (fr) * 1992-12-17 1994-06-23 Michael Andrew Coote Dispositif d'implant et procede pour le traitement du glaucome
GB2296663A (en) * 1995-01-03 1996-07-10 Ahmed Salih Mahmud Drainage device for alleviating excess ophthalmic fluid pressure
SE504146C2 (sv) * 1995-03-16 1996-11-18 Lars Ekberg Ultraljudsond
GB9700390D0 (en) * 1997-01-10 1997-02-26 Biocompatibles Ltd Device for use in the eye
US6168575B1 (en) * 1998-01-29 2001-01-02 David Pyam Soltanpour Method and apparatus for controlling intraocular pressure
US20040225250A1 (en) 2003-05-05 2004-11-11 Michael Yablonski Internal shunt and method for treating glaucoma
US7291125B2 (en) 2003-11-14 2007-11-06 Transcend Medical, Inc. Ocular pressure regulation
EP3005996B1 (fr) 2006-01-17 2019-12-04 Novartis Ag Dispositif de traitement du glaucome
CA2637602C (fr) 2006-01-17 2014-09-16 Forsight Labs, Llc Dispositif de traitement d'administration de medicament
EP2173289A4 (fr) 2007-07-17 2010-11-24 Transcend Medical Inc Implant oculaire avec de capacités d'expansion d'hydrogel
EP2334268B1 (fr) 2008-06-25 2017-08-02 Novartis Ag Implant oculaire à capacité de changement de forme
US8353856B2 (en) 2008-11-05 2013-01-15 Abbott Medical Optics Inc. Glaucoma drainage shunts and methods of use
JP5524983B2 (ja) 2009-01-28 2014-06-18 トランセンド・メディカル・インコーポレイテッド インプラントシステム
US8702639B2 (en) 2009-03-26 2014-04-22 Abbott Medical Optics Inc. Glaucoma shunts with flow management and improved surgical performance
US8529492B2 (en) 2009-12-23 2013-09-10 Trascend Medical, Inc. Drug delivery devices and methods
US10085633B2 (en) 2012-04-19 2018-10-02 Novartis Ag Direct visualization system for glaucoma treatment
US9241832B2 (en) 2012-04-24 2016-01-26 Transcend Medical, Inc. Delivery system for ocular implant
EP3228286A1 (fr) 2012-09-17 2017-10-11 Novartis AG Dispositifs d'implant oculaire expansible
US9763829B2 (en) 2012-11-14 2017-09-19 Novartis Ag Flow promoting ocular implant
US9987163B2 (en) 2013-04-16 2018-06-05 Novartis Ag Device for dispensing intraocular substances
US11672701B2 (en) 2018-10-25 2023-06-13 Amo Groningen B.V. Bleb control glaucoma shunts

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* Cited by examiner, † Cited by third party
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US3159161A (en) * 1962-11-14 1964-12-01 Ness Richard Alton Fistulizing canaliculus
US4787885A (en) * 1984-04-06 1988-11-29 Binder Perry S Hydrogel seton
GB2172203B (en) * 1985-03-14 1988-11-09 Univ Manchester A urethral catheter
NZ215409A (en) * 1986-03-07 1989-02-24 Anthony Christopher Be Molteno Implant for drainage of aqueous humour in glaucoma
US4826478A (en) * 1986-06-23 1989-05-02 Stanley Schocket Anterior chamber tube shunt to an encircling band, and related surgical procedure
US4886488A (en) * 1987-08-06 1989-12-12 White Thomas C Glaucoma drainage the lacrimal system and method

Non-Patent Citations (1)

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Title
See references of WO9112046A1 *

Also Published As

Publication number Publication date
SE9000491D0 (sv) 1990-02-12
SE9000491L (sv) 1991-08-13
WO1991012046A1 (fr) 1991-08-22

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