WO2024103105A1 - Instrument chirurgical ophtalmique et procédé d'utilisation - Google Patents

Instrument chirurgical ophtalmique et procédé d'utilisation Download PDF

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Publication number
WO2024103105A1
WO2024103105A1 PCT/AU2023/051147 AU2023051147W WO2024103105A1 WO 2024103105 A1 WO2024103105 A1 WO 2024103105A1 AU 2023051147 W AU2023051147 W AU 2023051147W WO 2024103105 A1 WO2024103105 A1 WO 2024103105A1
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WO
WIPO (PCT)
Prior art keywords
elongate
rupturing device
eye
rupturing
ophthalmic surgical
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.)
Ceased
Application number
PCT/AU2023/051147
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English (en)
Inventor
Jordan Green
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.)
Nova Eye Inc
Original Assignee
Nova Eye Inc
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 AU2022903468A external-priority patent/AU2022903468A0/en
Application filed by Nova Eye Inc filed Critical Nova Eye Inc
Publication of WO2024103105A1 publication Critical patent/WO2024103105A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/306—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/117—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for examining the anterior chamber or the anterior chamber angle, e.g. gonioscopes
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/006—Catheters; Hollow probes characterised by structural features having a special surface topography or special surface properties, e.g. roughened or knurled surface
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0293—Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube

Definitions

  • the present invention relates broadly to improved methodsand apparatusfor the reduction of elevated pressure in the human eye.
  • the present invention relates to an improved ophthalmic surgical instrument and a method of use of said instrument for performing trabeculotomy in patients suffering from glaucoma.
  • Glaucoma encompasses a group of eye diseases characterised by pathological changes in the optic disc and damage to the optic nerve of the eye, which, if left untreated, leads to irreversible vision loss.
  • the primary etiological factor in all forms of glaucoma is increased fluid pressure, or intraocular pressure, of the eye. Increased intraocular pressure is usually due to a resistance to the outflow of aqueous humour within the eye.
  • aqueous humour occurs in the trabecular meshwork located adjacent to the canal of Schlemm, or more specifically, the juxtacanalicular meshwork.
  • Trabecular meshwork tissue allows aqueous humour to enter the canal of Schlemm , interchangeably referred to as Schlemm ’s canal, which then drains into aqueous collector channels located in the posterior wall of the canal, eventually leading to aqueous veins.
  • Schlemm Schlemm ’s canal
  • the intraocular pressure of the eye is determined through balance between the production of aqueous humour and its exit through the trabecular meshwork (the major route) or through uveoscleral outflow (the minor route).
  • Trabeculotomy is a commonly performed procedure to reduce resistance in the outflow pathway of the eye and therefore reduce intraocular pressure in individualssuffering from glaucoma.
  • Transluminal trabeculotomy also referred to as circumferential trabeculotomy, involves disrupting or removing part or all of the trabecular meshwork along the circumference of Sehlem m’s canal by tearing, excising, cutting, or other techniques.
  • Gonioscopy Assisted Transluminal Trabeculotomy is a minimally invasive glaucoma treatment procedure involving visualising the eye through a gonioscope, also known as a gonioprism , and making one or more incisions in the cornea. These incisions, which are typically 1 mm in size, are made in the periphery of the cornea to access the anterior chamber of the eye. In some cases, an existing corneal incision from concurrent cataract surgery is utilised. After entering the eye, the procedure involves creating an incision or opening in the trabecular meshwork, cannulating Schlemm’s canal between 30 and 360 degrees, and unroofing the canal. GATT works by restoring the trabeculocanalicular outflow pathway, allowing increased flow of aqueous hum our from the anterior chamber directly into and around Schlemm’s canal, ultimately exiting through the collector channels. This effectively works to reduce intraocular pressure.
  • the other commonly practised technique involves inserting an elongated and flexible device, such as a catheter, suture, probe, or sim ilar member, into Schlemm’s canal. Once inside the canal, tension is applied to the device, or the device itself is used to exert a radial force, similar to a garrotte, within Schlemm’s canal. The radial force ruptures the trabecular meshwork that lines the section of Schlemm’s canal where the device is inserted.
  • One advantage of this method is that is allows the surgeon to titrate the size or angle of tear of the goniotomy performed, catering the procedure to the clinical requirements of the patient. Further, if a handpiece-propelled device is used, the technique may be performed using only one hand.
  • a shortcoming of the aforementioned method is that during the application of the radial force, a distal tip of the device may proximally shift within the canal, causing the device to partially exit the canal and reducing the size of the intended transluminal goniotomy. Furthermore, both methods do not present a simple way for the surgeon to visualise the extent of the transluminal trabeculotomy, with the surgeon requiring additional assistance or relying on experience.
  • the invention comprises an ophthalmic surgical instrument comprising a handpiece held by a user having a proximal and a distal end; the handpiece comprising a hollow shaft extending from the distal end of the handpiece; a flexible elongate rupturing device extending from the hollow shaft, wherein the elongate rupturing device is adapted to be advanced through tissue spaceswithin an eye.
  • the elongate rupturing device comprises a plurality of rearwardly and outwardly extending barbs; wherein the barbs are adapted to engage surrounding tissue within the tissue spaces of the eye.
  • the barbs are unidirectional.
  • the barbs are bidirectional.
  • the elongate rupturing device comprises a central hollow tube adapted to deliver a payload to the eye.
  • the elongate rupturing device is an optical fibre, the optical fibre being slidably engaged with the hollow shaft and having an outer diameter between 50 pm and 350 pm.
  • the invention comprises a method for performing trabeculotomy ab interno, the method comprising the steps of : making an incision in the trabecular meshwork of the eye to access the lumen of Sehlem m ’s canal; placing a distal end of an elongate rupturing device through the incision and into Sehlem m ’s canal ; advancing the elongate rupturing device through Sehlem m’s canal between an angle of 0 and 360 degrees; applying tension to the optical fibre within the canal thereby rupturing the surrounding tissue thereby creating a trabeculotomy; and withdrawing the device through the incision.
  • the elongate rupturing device comprises barbs located along the device, and wherein prior to applying tension to the optical fibre, the elongate rupturing device is slightly retreated proximally or tangentially to engage the barbs with the surrounding tissue.
  • the elongate rupturing device is advanced along the full circumference of Schlemm’s canal.
  • the elongate rupturing device is initially advanced 180 degrees, then repeating the procedure to then advance the remaining 180 degrees of the canal thereby creating a 360 degree trabeculotomy.
  • any one of the aspects mentioned above may include any of the features of any of the other aspects mentioned above and may include any of the features of any of the embodiments described below as appropriate.
  • Figure 1 is a side view of the ophthalmic surgical instrument
  • Figure 2 is a close-up side view of the barbed elongate rupturing device
  • Figure 3 is a close-up side view of the elongate rupturing device adapted to deliver a payload
  • Figure 4 is a close-up side view of the elongate rupturing device adapted to transmit light
  • Figure 5 illustrates several embodiments of the elongate rupturing device
  • Figure 6 illustrates a cross-sectional view of the structure of an eye
  • Figure 7 illustrates the creation of an incision in the trabecular meshwork of the eye
  • Figure 8 illustrates the advancement of the optical fibre within Sehlem m’s canal in the eye.
  • Figure 9 illustrates the completion of the trabeculotomy.
  • the ophthalmic surgical instrument 10 comprises a handpiece 12 with a grip 14 adapted to be held with one hand.
  • the handpiece 12 comprises aproximal and adistal end, wherein the distal end features a conical connector 16 from which a hollow shaft 18 extends.
  • An elongate rupturing device 20 emerges from the hollow shaft, adapted to be advanced into tissue spaces for use in ophthalmic surgery and used to cannulate spaces within the eye such as, but not limited to, the canal of Schlemm, aqueous humour collector channels, aqueous veins, retinal veins, and the suprachoroidal space.
  • the elongate rupturing device 20 is made from a flexible material, which enables the device 20 to be advanced through and follow the curvature of desired tissue spaces without damaging the surrounding tissue structure.
  • the distal end of the rupturing device 20 is appropriately shaped, for example with a curved distal end, for advancement along tissue spaces without rupturing the surrounding tissue.
  • the elongate rupturing device 20 comprises barbs 22 which allow the device 20 to be hooked to surrounding tissue during transluminal goniotomy, avoiding slippage of the device 20.
  • the barbs 22 may be structured to allow for retraction when the device is distally pushed and advanced along tissue spaces, while protruding when the device is retracted proximally.
  • the angle of the barbs 22 allowing for different ease of hooking with the surrounding tissue; the barbs 22 more likely to latch onto surrounding tissue as their angle of protrusion approaches 90°.
  • the barbs 22 may be arranged in any manner allowing for the elongate rupturing device 20 to remain anchored astension is applied to the device 20 or as the device is retracted proximally. Barbs 22 may extend partially or completely along the length and circumference of the device 20 and arranged in any suitable manner. Of importance is the presence of barbs 22 near the distal end of the device 20 to prevent any movement or slippage of the distal end of the device 20 when rupturing the surrounding tissue.
  • the barb orientation is unidirectional, but the invention also allows for bi-directional barbs 22 with varying sizes. This arrangement significantly enhances resistance to catheter migration. It accomplishes this by requiring the barbs, which oppose movement in a specific direction, to traverse a longer section of tissue before being withdrawn or displaced from it.
  • the barbs may also be of varying shapes, widths and sizes, for example, the barbs located at the distal end of the device 20 may be longer or shorter than barbs located at a proximal end of the device 20.
  • the barbs may be a single ring extending around the device 20 providing a wall that extends outwardly and proximally with an edge adapted to latch onto tissue.
  • Yet other types of anchoring devices may also be used.
  • the elongate rupturing device is a flexible hollow tube, such as a catheter.
  • the flexible hollow tube features an inner hollow section 25 suitable for and delivering a solid or fluid payload into desired tissue spaces.
  • payloads may be located within a payload storage unit 26 containing a hollow volume 28 adapted to hold the payload.
  • the payload storage unit 26 may be located within the handpiece 12, however, it is not limited to such aconfiguration and may very well be located external of the surgical instrument.
  • Payloads may comprise a fluid and/or solid object such as a stent or drug.
  • fluid payloads include, but are not limited to, viscoelastic fluids, saline solutions, and aqueous solutions.
  • Solid payloads include, but are not limited to, microsurgical instruments such as forceps, instruments for penetrating tissue, instruments for cutting tissue, stents, light guides, and wires.
  • the elongate rupturing device 20 may comprise a light source (not illustrated) for illuminating the distal end of the device.
  • the light source may be coupled to the device, directing light through said device and providing illumination.
  • the light source may also be coupled to a light guide to illuminate the distal end of the catheter, wherein a light guide refers to optical elements capable of transmitting electromagnetic radiation through the guide.
  • Such light guides may include, but are not limited to, mirrors arranged to direct light from a source to a destination, a flexible optical fibre, and a bundle of optical fibres.
  • the elongate rupturing device 20 may comprise a connector located at the proximal end of the handpiece.
  • the connector may facilitate, without limitation, an illumination source, or an external payload to be coupled to the device 20.
  • the illumination source coupled to the device may be used to illuminate itsdistal end.
  • the elongate rupturing device 20 is slidably engaged with the handpiece 12, allowing for extension or retraction of the rupturing device 20 to a desired length.
  • the elongate rupturing device 20 may be manufactured from a variety of suitable materialsto allow for insertion into the body and for delivering fluid payloads.
  • suitable materials are well known in the art, such as but not limited to polymers such as polyimides, polyamides, polyolefins, polyvinylchlorides, fluoropolymers, polysulfones, polyurethanes and compositions thereof .
  • the elongate rupturing device 20 is a flexible optical fibre adapted to mechanically rupture tissue. Such an optical fibre may be approximately 200 pm in length. Illuminated rupturing devices allow the surgeon to visualise the location of the rupturing device 20 as it is inserted and advanced along desired tissue spaces, allowing for increased accuracy in the location of tearing.
  • the optical fibre as the elongate rupturing device 20 may be distally illuminated 21 or may be longitudinally illuminated 23 along the length of the device, dependent on its material.
  • the optical fibre may be made from material appropriate for simultaneously transmitting light and rupturing tissue.
  • materials may include, but not are not limited to silica, doped silica including germanium-doped or phosphorus-doped silica, plastic including polymethyl methacrylate or polycarbonate, glass including fluoride glass, chalcogenide glass or heavymetal oxide glass, and polymer optical fibres made from perfluorinated polymers or polyethylene.
  • optical fibre as a rupturing tool offers an additional advantage of reduced production costs for the surgical apparatus. Unlike existing prior art devices that include catheters or similar devices that typically consist of a hollow tube for delivering a payload, the optical fibre of the invention does not require such components for payload delivery. Thisdesign simplicity resultsin a more cost -effective manufacturing processthrough the elimination of the hollow tube and payload delivery mechanism.
  • the instrument may include connections for coupling light from light source. The mechanism of directing light through an optical fibre iswell known in the art.
  • Detailed methods for performing transluminal trabeculotomy ab interno utilising the invention is described as follows.
  • the described method allows for the alleviation of intraocular pressure for the treatment of glaucoma.
  • the lumen of Schlemm’s canal is accessed from the anterior chamber without the need or requirement for dissection of the sclera or conjunctiva. This is possible because the inner wall of Schlemm’s canal, the trabecular meshwork, is directly adjacent to the anterior chamber.
  • FIG. 6 a cross-sectional representation of the eye is provided.
  • the lens 32, iris 34, cornea 36, location of the trabecular meshwork 28, and the canal of Sehlem m 40 are visible.
  • a microsurgical instrument is used to create a goniotomy, or incision, of Schlemm ’s canal.
  • the incision is made from within the anterior chamber with the aid of a gonioprism or other imaging device to visualise the anterior chamber angle.
  • an incision 42 is made in the trabecular meshwork 38 using a cutting instrument (not shown) from within the anterior chamber.
  • the rupturing device 20 may then be used to cannulate the goniotomy opening, i.e., the device is inserted into the goniotomy opening and advanced along Schlemm’s canal 30.
  • the device may be advanced within the canal to a desired angle, typically between 0 and 360 degrees.
  • the device 20 may be advanced through the canal by hand, the user applying a force to the handpiece 12 to facilitate advancement along the canal.
  • a gripping instrument 44 may be used to aid in positioning and advancing the device 20 through the canal.
  • the gripping instrument 44 may be but is not limited to a surgical forceps or an ocular micro forceps.
  • the device 20 is advanced through Schlemm’s canal to desired angle between 0 and 360 degrees, before retracting (pulling) the instrument 10 slightly proximally or tangentially allowing the barbs to engage with the surrounding tissue. Traction or tension may then be applied to the device 20, to pull the device into the anterior chamber, thereby rupturing the trabecular meshwork, exposing Schlemm’s canal to alleviate intraocular pressure. The device may then be further advanced along Schlemm’s canal and retrieved using the gripping instrument 44.
  • an incision is made through the cornea 36 for insertion of the elongate rupturing device 20.
  • the elongate rupturing device 20 is advanced within Schlemm’s canal until the distal end of the optical fibre is near the initial goniotomy incision, i.e., 360 degrees.
  • the gripping instrument 44 may then be used to retrieve the distal end of the end of the device 20 as illustrated in Figure 8. Traction or tension may then be applied to the device 20 to pull the device into the anterior chamber, thereby rupturing the trabecular meshwork, exposing Schlemm’s canal, and creating a 360 degree trabeculotomy 46 ab interno as shown in Figure 9.
  • the trabeculotomy procedure utilising the surgical apparatus is performed on a portion of Schlemm’s canal as a partial trabeculotomy.
  • the device 20 is partially advanced through Schlemm’s canal 30 degrees or more.
  • the distal end of the device 20 may then be retrieved through the trabecular meshwork via a goniotomy. Applying tension to one or both ends of the optical fibre then forms a partial trabeculotomy between the goniotomy and the distal end of the device.
  • the trabeculotomy may continue to be applied to the untreated portion of Schlemm’s canal by cannulating the remaining portion of the canal and repeating the partial trabeculotomy procedure.
  • the entire canal could be treated by two 180 degree procedures, three 120 degree procedures, or other desired combinations.
  • only a portion of Schlemm’s canal may be cannulated and a partial trabeculotomy performed using the technique described.
  • the device 20 that is used to cannulate Schlemm’s canal comprises may be flexible, and is of a suitable size, shape, and thickness to enter and cannulate the circumference of the canal.
  • Schlemm's canal has a meridional diameter typically ranging from 200 to 250
  • the reported length of the canal is approximately 36 m m, although there may be some variation depending on factors such as the size of the eye or existing disease conditions.
  • the device 20 is approximately between 50 pm and 350 pm in diameter, and has a length of at least 36 mm .
  • the device may have a lubricious coating on at least the distal end.
  • Such coatings may be hydrophilic or hydrophobic in nature, and are common knowledge in the art.
  • a hydrophilic coating may be applied to aid in intubation of the device within the eye, whereas hydrophobic coatings may aid in retention of the device within structures of the eye.
  • the device may be straight, or also incorporate a curve at the distal end. The curve may be greater than or approximate the curvature of Schlemm ’s canal.
  • the curved tip has a radius ranging from 2 to 4 mm.
  • the device may have markings along the length of the device or at the tip to help visualisation of the device within the canal.
  • the device 20 may transmit light from a light source, emitting light to allow the location of the device 20 to be visualised through the trabecular meshwork from within the eye as well as through the sclera and conjunctiva from outside the eye to provide guidance for advancement within the canal.
  • An advantage of the presently described ab interno approach is that it does not require a conjunctival or scleral incision. As such, no scleral dissection is required and there is no risk of causing a pulmonary bleb on the surface of the eye. Ibis approach also spares the entire conjunctiva and sclera, which is ideal in the event that traditional glaucoma surgery or other eye surgery is needed in the future. Post-operatively, the recovery time is at least on par with patients who have undergone a 360 degree trabeculotomy ab externo.
  • a lid speculum is placed in the eye and a gonioprism (or other anterior chamber angle imaging device) is placed onto the eye.
  • the surgical microscope is tilted so that the anterior chamber angle at the goniotomy site can be appreciated.
  • the ciliary body structures, the trabecular meshwork, as well as the scleral spur in the anterior chamber angle are identified.
  • a tangential paracentesis incision is made in the cornea, through which an intraocular composition is injected in order to constrict the pupil and facilitate access to the trabecular meshwork from the anterior chamber.
  • the composition that is used comprises acetylcholine. Examples of such compositions include M iochol-E®and M iostat®
  • a surgical viscoelastic such as a solution of sodium hyaluronate is injected into the anterior chamber of the eye to maintain or enlarge the chamber dimensions.
  • the composition may include, but are not limited to Healon® a non-pyrogenic solution of a highly purified high molecular weight fraction of sodium hyaluronate extracted from animal tissue dissolved in a physiological buffer.
  • Healon® a non-pyrogenic solution of a highly purified high molecular weight fraction of sodium hyaluronate extracted from animal tissue dissolved in a physiological buffer.
  • a different microsurgical blade is inserted into the corneal incision and used to form a goniotomy by incising the trabecular meshwork in the region directly across the eye from the corneal incision to create direct access to the lumen of Sehlem m’s canal.
  • the device 20 is inserted into the paracentesis and the gonioprism is placed on the eye to visualise the distal end of the device approaching the angle structures in the incised region of the canal.
  • Surgical forceps are then inserted into the eye through the clear corneal incision. These are used to grasp the device and direct the distal part of the device into the incision of Schlemm’s canal.
  • the gonioprism (or other device used to image the anterior chamber angle) is placed in or on the eye and allows visualisation of this procedure.
  • the device is threaded into Schlemm’s canal through the incision created by the microsurgical blade.
  • the positioning of the device 20 isconfirmed through an external view of the eye.
  • the transillumination of the light of the device 20 in Schlemm ’s canal can be visualised internally or externally.
  • the surgical forceps may be placed back into the eye with a gonioprism on the eye for visualisation and the optical fibre advanced around the canal.
  • the distal end of the device is retrieved with the surgical forceps and removed from the eye through the clear corneal incision, creating a 180 degree trabeculotomy in the inferior quadrant.
  • the 360 degree trabeculotomy may then completed by grasping and applying tension to the proximal end of the optical fibre to finish the trabeculotomy 180 degrees superiorly.
  • the device is then removed from the eye through the paracentesis.
  • an endoscopic camera may be used to visualise the surgical procedure within the anterior chamber to facilitate proper placement and use of the instruments within the anterior chamber.
  • blood reflux is typically noted from the canal.
  • Surgical viscoelastic may be injected into the eye to reform the chamber and maintain adequate pressure with the additional goal of blocking the flow of blood.
  • a single suture such as an interrupted 10-0 nylon suture is placed through the clear corneal incision if needed.
  • the previously injected surgical viscoelastic is irrigated out of the anterior chamber, as is blood that has refluxed into the anterior chamber. The suture is then tied off and the eye pressurised by injection of balanced salt solution to a pressure of at least 10-15 mm Hg by palpation.

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Abstract

Instrument chirurgical ophtalmique comprenant une pièce à main, un système de préhension et une tige creuse avec un dispositif de rupture allongé s'étendant de manière coulissante à partir de la tige creuse. Le dispositif de rupture allongé est conçu pour être inséré dans des espaces tissulaires à l'intérieur de l'œil. Dans des modes de réalisation de l'invention décrits, le dispositif de rupture allongé peut être un cathéter avec barbillons, ou une fibre optique, ou conçu pour administrer une charge utile dans l'œil, ou toute combinaison de ces éléments. L'instrument chirurgical ophtalmique est utilisé dans une trabéculotomie transluminale ou circonférentielle pour rompre le tissu à l'intérieur de l'œil pour réduire la pression intraoculaire chez des patients souffrant d'un glaucome.
PCT/AU2023/051147 2022-11-17 2023-11-13 Instrument chirurgical ophtalmique et procédé d'utilisation Ceased WO2024103105A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
AU2022903468A AU2022903468A0 (en) 2022-11-17 Barbed ophthalmic catheter and a method of use of the catheter
AU2022903468 2022-11-17
AU2023902287 2023-07-18
AU2023902287A AU2023902287A0 (en) 2023-07-18 Opthalmic surgical handpiece with optical fibre

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Publication Number Publication Date
WO2024103105A1 true WO2024103105A1 (fr) 2024-05-23

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JP (1) JP2024073371A (fr)
AU (2) AU2023237150A1 (fr)
WO (1) WO2024103105A1 (fr)

Citations (6)

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