EP1924229A1 - Dispositif destine au traitement d'un glaucome - Google Patents

Dispositif destine au traitement d'un glaucome

Info

Publication number
EP1924229A1
EP1924229A1 EP06762418A EP06762418A EP1924229A1 EP 1924229 A1 EP1924229 A1 EP 1924229A1 EP 06762418 A EP06762418 A EP 06762418A EP 06762418 A EP06762418 A EP 06762418A EP 1924229 A1 EP1924229 A1 EP 1924229A1
Authority
EP
European Patent Office
Prior art keywords
cannula
aspiration
eye
infusion
distal end
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.)
Withdrawn
Application number
EP06762418A
Other languages
German (de)
English (en)
Inventor
Demetrio Romeo
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.)
Dutch Ophthalmic Research Center International BV DORC
Original Assignee
Dutch Ophthalmic Research Center International BV DORC
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
Priority claimed from ITRC20050010 external-priority patent/ITRC20050010A1/it
Priority claimed from ITRC20060004 external-priority patent/ITRC20060004A1/it
Application filed by Dutch Ophthalmic Research Center International BV DORC filed Critical Dutch Ophthalmic Research Center International BV DORC
Publication of EP1924229A1 publication Critical patent/EP1924229A1/fr
Withdrawn legal-status Critical Current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
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants

Definitions

  • the present invention relates to a medical device for the treatment of open angle glaucoma through direct surgery on trabecular meshwork.
  • Glaucoma is a group of eye diseases that can damage the eye's optic nerve and can cause corresponding visual field loss resulting in blindness if left untreated.
  • the eyeball is basically a rigid sphere filled with fluids.
  • the first two chambers are filled with a clear fluid called aqueous humour whereas the vitreous chamber is filled with a more viscous fluid, the vitreous humour.
  • the aqueous humour or "aqueous" carries nutrients to the lens and cornea, both of which have no blood supply.
  • aqueous is constantly secreted by the ciliary body (which is located behind the iris and around the lens) and flows from the posterior chamber through the pupil into the anterior chamber and drains out of the eye through a spongy tissue called trabecular meshwork (TM).
  • TM trabecular meshwork
  • TM is located in the drainage angle of the anterior chamber, between the internal periphery of the cornea and the outer rim of the iris at the location where the iris meets the external wall of the eye (sclera).
  • the fluid drains from the TM into a small canal (the Schlemm canal), then into aqueous collector channels and into aqueous veins.
  • Glaucoma is roughly classified into two categories: closed angle glaucoma and open angle glaucoma.
  • the closed angle glaucoma is caused by closure of angle of the anterior chamber by contact between the iris and the inner surface of the TM. Closure of this anatomical angle prevents normal drainage of aqueous from the anterior chamber. In open angle glaucoma the angle of the anterior chamber remains open, but the exit of aqueous through the TM is diminished. The source of resistance to outflow is in the TM.
  • Surgical therapy for open angle glaucoma consists of the following methods:
  • Neodymium YAG laser has been investigated as an optically invasive technique for creating a hole through the total thickness of the TM.
  • the relatively small hole created by this trabeculopuncture technique is subject to a filling in effect, eventually . causing treatment failure.
  • Argon laser can be used to form scar tissue that contracts and pulls on the TM to improve outflow of aqueous. In many cases this technique fails and very often the treatment needs to be repeated after a period of time.
  • Goniotomy/trabeculotomy are simple and direct microsurgical dissection techniques with mechanical destruction of the TM. Initially this surgery provided favourable responses, however long term results showed only limited success in adults. These procedures probably failed later following repair mechanisms and "filling" processes. The "filling in” effect is the result of the healing process forming scars, which have the detrimental effect of collapsing and closing the opening that has been created in the TM. Once this opening is closed the pressure builds up inside once more and the surgery fails.
  • Goniocurettage This is an ab-interno (performed from the inside) mechanical destructive technique. An instrument similar to a cyclodialysis spatula is used with a microcurette on the tip. Initial results are similar to trabeculotomy with subsequential failure following repair mechanisms and the filling in process.
  • Trabeculectomy This is the most commonly performed filtering surgery. It involves creating a tiny filtering valve in the sclera. This procedure controls pressure by creating a new drainage channel through the angle structures to the extracellular space beneath the conjunctiva.
  • Trabeculectomy is a major surgery and is aided with locally applied anticancer drugs such as 5-flurouracil or mitomycin-c to reduce scarring and increase surgical success.
  • Current mortality associated with trabeculectomy consists of failure (10-15%), infections (a life long risk about 2-5%), choroidal haemorrhage (1%, a severe internal haemorrhage from insufficient pressure resulting in visual loss), cataract formation, and hypotony maculopathy (potentially reversible visual loss from insufficient pressure).
  • Another disadvantage of this procedure is that the body's natural healing process may gradually close the filter, causing the pressure to rise again.
  • Viscocanulostomy (VC) and Non Penetrating Trabeculectomy (NPT) are two new variations of filtering surgery. These are both major surgery procedures in which the Schlemm canal is surgically exposed by making a large and very deep scleral flap.
  • the Schlemm canal is canulated and a viscoelastic substance injected (which dilates the Schlemm canal and aqueous collector channels).
  • the inner wall of the Schlemm canal is stripped away after the canal has been surgically exposed.
  • Trabeculectomy, VC and NPT are performed under a conjunctival and scleral flap so that the aqueous is drained onto the surface of the eye or into the tissues located near the lateral wall of the eye. Normal physiological outflows are not used.
  • Drainage devices When Trabeculectomy, VC and NPT are not considered to have good probabilities of success, a number of implantable drainage devices are used to ensure that the desired filtration and outflow of aqueous through the surgical opening can continue. Placing glaucoma drainage implants also increases the risk of haemorrhage, infection and postoperative double vision that is a complication unique to drainage implants.
  • the treatment procedures and variations described above have numerous disadvantages and are generally only moderately successful. They involve considerable trauma to the eye and require great surgical skill to create a hole in the total thickness of the sclera/cornea in the sub-conjunctival space. Furthermore, normal physiological outflow pathways are not used. Procedure is lengthy and requires an operating theatre and the presence of an anaesthesiologist with all the costs involved, and the vision recovery time is also a long process.
  • TM and juxtacanalicular tissues both create the main resistance to aqueous outflow and for this reason they are the logical targets for surgical treatment of open angle glaucoma.
  • Trabecular surgery has a much lower potential risk of choroidal haemorrhage, infections and furthermore, it aims at restoring physiologic outflow mechanisms. This surgery can be performed under local anaesthesia with rapid visual recovery.
  • the aim of the present invention is to eliminate the disadvantages of the prior art by providing a device for the treatment of open angle glaucoma which is efficacious, easily used by the surgeon, while at the same time, being specifically created for operating in the seat of the diseased area.
  • the Applicant has created a device according to the invention based on a simple logical process: a) In order to maintain the normal anatomy of the eye and to prevent the complications induced by trauma to the tissue, it is essential to restore the natural outflow canals rather than destroy them, open new canals or create a by-pass system. b) The outflow canals do not function because they are blocked by matter deposited in the TM over a period of time. c) The delicate removal of this matter restores the natural outflow without damaging the filtering structure.
  • step 1) can be performed using a very small scalpel, commonly used in ophthalmic surgery
  • steps 2) and 3) are carried out using the device according to the invention which comprises:
  • an infusion cannula associated with said aspiration cannula, to infuse a poly-saline solution into the anterior chamber of the eye, in order to maintain the original open spaces and to compensate the aspiration action on the TM.
  • the tip of these instruments generally has an external diameter of approximately 1.2 mm and tapers to 0.8 mm only at the very end of the tip for a length of about 2 mm.
  • the special two-way cannula according to the present invention is composed of an associated system of infusion and aspiration, able to penetrate the eye through a very small temporary and self-closing incision in the cornea, made by a small scalpel, (of the type commonly used in ophthalmic surgery).
  • the said two-way cannula is able to attain the TM situated in the angle of the anterior chamber and remove any matter that blocks the TM, by means of aspiration.
  • the device according to the invention can be extracted from the eye.
  • An expert surgeon is capable of performing this procedure in less than a minute.
  • FIG. 1 is a cross section illustrating the general anatomy of the eye
  • FIG. 2 is a view in perspective, showing an enlarged cross section of the angle between the iris and the cornea;
  • FIG. 3 is a view in axial cross section, showing the device for treating glaucoma according to the invention
  • FIG. 4 is a cross section showing the device shown in Fig 3 inserted in the anterior chamber of the eye to aspirate the TM.
  • FIG. 1 shows certain anatomic details of the eye: cornea 1, conjunctiva 2, extrinsic ocular muscle 3, ciliary body 4, lens 5, iris 6, choroid 7, sclera 8, retina 9, optic nerve 10, macula 11, optic papilla 12, anterior chamber 13, posterior chamber 14, and vitreous chamber 15.
  • FIG. 2 shows in greater detail the trabecular meshwork 16, and the Schlemm canal 17.
  • the device according to the invention comprises two components: an infusion cannula and an aspiration cannula which can be easily connected to each other in parallel mode, overlaid, or placed in coaxial mode.
  • FIG. 3 shows the solution where the two cannulae are associated in a coaxial manner.
  • the device according to the invention comprises an external cannula 18 and an internal cannula 19 positioned co-axially inside the external cannula 18.
  • the external cannula 18 is used for infusion and also acts as a handle, while the internal cannula 19 is used for aspiration.
  • the infusion cannula 18 extends from a proximal end (destined to be held by the surgeon) and a distal end (destined to penetrate inside the anterior chamber of the patient's eye). Beginning from the proximal end, the infusion cannula 18 presents a first section having a larger diameter, and a second section 21 with a narrower diameter. The second section with the lesser diameter 21 can be either formed in a single part or be separated from the first section.
  • the first section of the external cannula 18 extends for a length that can vary within a range from a minimum of 20 mm as far as a maximum of 150 mm and even more, and has an external diameter ranging between 5 and 12 mm so that it can be easily held in the surgeon's hand.
  • the first section of the external cannula 18 has an internal diameter that can vary (within a minimum between 1.4 and 0.65 mm) so that it can define an adequate infusion canal. Therefore the thickness of the wall in this first section of the external cannula 18 can vary considerably.
  • a standard female type connection 20 for syringes is foreseen close to the proximal end of the first section of the internal cannula 18.
  • the axis of the female connection 20 is on a slant at an approximate angle of 45°, in relation to the axis of the first section of the external cannula 18, for easy fluid injection.
  • the axis of the female connection 20 can also be set at a different angle in relation to the axis of the external cannula 18.
  • the second section 21 which has a narrower diameter than the external cannula 18 is destined to penetrate inside the anterior chamber 13 of the eye, and therefore it is approximately 2.5 cm long with an external diameter ranging from a maximum of 1.6 mm to a minimum of 0.65 mm, preferably less than 1.2 mm.
  • the second section 21 of the external cannula terminates with an opening similar to a truncated needle.
  • the aspiration cannula 19 is inserted in an axial manner inside the infusion cannula 18.
  • Sealing means 22, such as O-ring seals, can be placed between the two cannulae 18 and 19, preferably close to the proximal end, so that no air or liquid is able to exit from the proximal end.
  • the external diameter of the aspiration cannula 19 is narrower than the internal diameter of the infusion cannula, in order to generate a toroidal space between the two cannulae through which a fluid can be infused.
  • the external diameter of the aspiration cannula 19 can vary between 0.20 and 0.70 mm.
  • the proximal end of the internal cannula 19 presents a standard male type conical connection which protrudes from the proximal end of the external cannula 18.
  • the internal cannula 19 presents a distal portion 24 that protrudes from the distal end of the second section 21 of the external cannula for a distance of about 2-3 mm.
  • the distal end 24 of the aspiration cannula 19 can continue with a segment of tubing 25 made from a pliable material (silicone, teflon, polyamide, etc.) that extends from the internal cannula 19 by about a further 2 - 5 mm. In this manner, the distal end 24 of the aspiration cannula 19 protrudes outside the distal end of the section with the narrower diameter 21 of the external cannula, for a distance of about 4 - 8 mm.
  • the tube 25 must be as small as possible (with a maximum external diameter equal to or less than 0.65 mm, preferably ranging between 0.12 mm and 0.5 mm, and an internal diameter equal to or less than 0.30 mm).
  • the segment of tube 25 in pliable material can be welded or glued to the distal end 24 of the aspiration cannula 19, and can also be inserted either on the outside or inside of the distal end.
  • FIG. 3 shows the first possibility where the tube 25 is welded or glued to the distal end 24 of the aspiration cannula 19.
  • it is possible to obtain good results by inserting the pliable tube 25 hermetically for a short distance into the terminal section 24 of the aspiration cannula 19, or, on the contrary, by inserting the terminal end 24 of the aspiration cannula hermetically inside the pliable tube 25 for a distance of 1-2 millimetres. In this manner, the distal end of the pliable tube 25 is the only part of the instrument which is in contact with the TM 16.
  • the whole aspiration cannula 19, or the last distal section of the cannula 19 can be made in a semirigid or flexible material, or at least in a material that causes no trauma, while maintaining the same overall length, the same diameters and the same proportions, but eliminating the need for the pliable tube 25.
  • the diameter of the infusion cannula 18 and the aspiration cannula 19, are connected proportionally so that the infused liquid flow which passes through the space between the two cannulae is equal to or more than the liquid aspirated through the canal of the aspiration cannula 19.
  • the female 20 and male 23 connections mounted on the device permit easy assembly to both manual infusion-aspiration systems as well as the automatic systems used in ophthalmic surgery.
  • the flow of the fluids into the device according to the invention are shown in Fig. 3 by the arrows.
  • the fine arrows show the direction of the infusion liquid, and the thick arrows show the direction of the aspirated liquid.
  • the two cannulae 18 and 19 can be made from materials that can be re-sterilized (steel, silicone, and similar materials), or in non-resterilizable disposable material (plastic and similar materials) or partly in metal and partly in synthetic material.
  • the disposable infusion-aspiration systems currently on the market are mounted with female connections for both infusion and for aspiration, and this can cause connection error, making the use of a double male adaptor necessary.
  • the automatic aspiration systems used in ophthalmic surgery have been equipped for several years with non-invertible ends which are designed for male-female connection on the aspiration line and female-male connection on the infusion line.
  • the re-sterilizable systems on the market have non-invertible connections
  • the disposable systems sold by the main manufacturers like Becton Dickinson, Oasis Medical, Eagle Laboratories, etc. are equipped with female connections for both lines.

Abstract

Cette description concerne un dispositif destiné au traitement d'un glaucome composé de: - une canule d'aspiration (19) conçue de manière à pénétrer la chambre antérieure (13) de l'oeil afin d'aspirer le trabéculum cornéoscléral (16) et - une canule d'infusion (18), associée à la canule d'aspiration (19), afin d'infuser une solution polysaline stérile dans la chambre antérieure (13) de l'oeil, afin de maintenir les espaces ouverts originaux et de compenser l'action d'aspiration sur le trabéculum cornéoscléral (16).
EP06762418A 2005-07-14 2006-07-05 Dispositif destine au traitement d'un glaucome Withdrawn EP1924229A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ITRC20050010 ITRC20050010A1 (it) 2005-07-14 2005-07-14 "cannula di infusione-aspirazione a due vie per la disostruzione del trabecolato oculare nella chirurgia del glaucoma"
ITRC20060004 ITRC20060004A1 (it) 2006-02-16 2006-02-16 Dispositivo dedicato ad un nuovo metodo di trattamento del glaucoma ad angolo retto.
PCT/EP2006/006552 WO2007006466A1 (fr) 2005-07-14 2006-07-05 Dispositif destine au traitement d'un glaucome

Publications (1)

Publication Number Publication Date
EP1924229A1 true EP1924229A1 (fr) 2008-05-28

Family

ID=36997750

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06762418A Withdrawn EP1924229A1 (fr) 2005-07-14 2006-07-05 Dispositif destine au traitement d'un glaucome

Country Status (2)

Country Link
EP (1) EP1924229A1 (fr)
WO (1) WO2007006466A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9351871B2 (en) * 2008-11-12 2016-05-31 Alcon Research, Ltd. Distal plastic end infusion/aspiration tip
US9433725B2 (en) 2011-12-23 2016-09-06 Alcon Research, Ltd. Combined coaxial and bimanual irrigation/aspiration apparatus
KR102240262B1 (ko) 2013-06-06 2021-04-14 알콘 인코포레이티드 변환기 세척/흡인 장치

Family Cites Families (6)

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Publication number Priority date Publication date Assignee Title
US4014333A (en) * 1975-09-22 1977-03-29 Mcintyre David J Instrument for aspirating and irrigating during ophthalmic surgery
US5084012A (en) * 1991-03-22 1992-01-28 Kelman Charles D Apparatus and method for irrigation and aspiration of interior regions of the human eye
US5242449A (en) * 1991-04-23 1993-09-07 Allergan, Inc. Ophthalmic instrument
US5441496A (en) * 1993-04-15 1995-08-15 Infinitech, Inc. Laser delivery system with soft tip
US5718677A (en) * 1997-02-14 1998-02-17 Alcon Laboratories, Inc. Soft aspriation tip
US6800076B2 (en) * 2000-10-18 2004-10-05 Retinalabs, Inc. Soft tip cannula and methods for use thereof

Non-Patent Citations (1)

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Title
See references of WO2007006466A1 *

Also Published As

Publication number Publication date
WO2007006466A1 (fr) 2007-01-18

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