WO2022101648A1 - Dispositif ophtalmologique et instrument - Google Patents

Dispositif ophtalmologique et instrument Download PDF

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Publication number
WO2022101648A1
WO2022101648A1 PCT/GB2021/052963 GB2021052963W WO2022101648A1 WO 2022101648 A1 WO2022101648 A1 WO 2022101648A1 GB 2021052963 W GB2021052963 W GB 2021052963W WO 2022101648 A1 WO2022101648 A1 WO 2022101648A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
cannula
eye
surgery
annular space
Prior art date
Application number
PCT/GB2021/052963
Other languages
English (en)
Inventor
Anant Sharma
Original Assignee
Anant Sharma
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 Anant Sharma filed Critical Anant Sharma
Priority to CN202180090825.5A priority Critical patent/CN116801848A/zh
Priority to EP21814851.8A priority patent/EP4243747A1/fr
Publication of WO2022101648A1 publication Critical patent/WO2022101648A1/fr

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
    • 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

Definitions

  • the present application relates to devices, optionally including instruments such as cannulas, for performing intraocular surgery including hydro-dissection and/or hydro-dilation, particularly during cataract surgery.
  • a cataract is a clouding of the lens inside the eye causing vision loss, which cannot be corrected without surgery since lens replacement is required (with an artificial lens).
  • Hydrodissection is an essential step during "phacoemulsification" procedure where the lens is broken with an ultrasonic instrument and sucked out), because it allows separation of the cortex from the capsule of the eye.
  • the spatial separation facilitates easier and more complete cortical removal with less stress on the zonules; the rings of fibrous strands that connect the ciliary body with the crystalline lens of the eye.
  • Hydrodissection also allows nuclear mobility to aid fragmentation of the cataract. This surgical step gives much cause for concern to surgeons as it routinely involves an uncontrolled risk factor resulting in one or more surgical complications. It is of particular importance that fluid is drained from the eye when the intraocular pressure increases due to the hydrodissection wave, in order to prevent iris prolapse (where the iris pushes itself through the incision).
  • IOP Intraocular pressure
  • This device has a cannula which is surrounded by a sleeve, so that an annular space is created between the cannula and the sleeve. This annular space allows fluid that is injected into the eye through the cannula to escape from the eye via the sleeve via openings formed along the sleeve.
  • the invention relates to an ophthalmological device for performing eye surgery, particularly cataract surgery including hydro-dissection and / or hydro-dilation.
  • the invention concerns an ophthalmological device for use with a normal hydrodissection cannula or lens injector i.e. the device can be fitted over the instrument when desired or the invention can incorporate the instrument itself i.e. an ophthalmological device including an integrated cannula and/or injector.
  • the device disclosed herein comprises an elongate flexible sleeve for making a peripheral seal with ocular layer(s), the sleeve being adapted to surround a majority of a cannula, optionally integrated therewith, to define an elongate annular space between the sleeve and the cannula, wherein the sleeve comprises at least one distally located fluidic entry point and at least one proximally located fluidic exit point, spatially distanced along a length of the sleeve from the entry point.
  • the invention therefore effectively permits intraocular pressure to be managed since intraocular fluid in the eye can access the annular space of the device at the distal end, pass through the device via the length of the annular space and be emitted therefrom.
  • the distal end of the device maybe arranged to facilitate penetration through the layer(s) of the eye.
  • the cannula will typically extend a short distance beyond the distal end of the sleeve.
  • the term "cannula” is to be understood in the broadest sense. This can be a tubular element of almost any shape, through which liquid can be introduced into the eye. The cannula can be pointed and / or sharp at its distal end.
  • Such a device may be safely placed and/or secured past the pupil margin, for example, during cataract surgery.
  • Techniques/ manoeuvres such as hydro-dissection, as described during cataract removal, can be carried then out by the surgeon with reduced risk of complication.
  • any excess fluid in the eye may safely move from an internal chamber, at the working surgical site of the cataract, through the entry aperture towards a distal end of the device and will flow via the internal channel of the core structure and out the proximal end via the exit aperture.
  • the device of the invention allows the surgeon to continue to undertake a surgical procedure in the eye with reduced concern about uncontrolled change in IOP.
  • the invention provides the function of introducing the fluid necessary for hydrodissection via the cannula but uses that structure together with other features to effectively permit excess fluid or build up at the surgical site, which can be drained away from the eye, thereby managing the intraocular pressure.
  • the sleeve structure is elongate and hence shaped like a tube.
  • the sleeve maybe compressible, deformable or otherwise malleable to ensure the device can be inserted easily through an incision but remain fitted to the ocular layer(s) through which it passes.
  • the core structure of the device typically comprises a proximal end (proximal to the user/surgeon) and a distal end.
  • the entry apertures are at the distal end to the surgeon and the exit apertures are at the proximal end such that excess fluid moves away from the surgical site and out of the eye.
  • the material of the sleeve can be selected and the dimensions adapted in such a way that the sleeve is flexibly pressed against the cannula by the surrounding ocular tissue, in particular by the sclera, so that the annular space is temporarily pushed "closed".
  • the liquid moves toward the entry points and into the sleeve to push against outer wall (of the sleeve) with sufficient pressure so that the annular space is opened.
  • an inherent valve may operate by virtue of the pressure differential.
  • the sleeve may incorporate an internal one way valve within the annular space.
  • the sleeve of the device may further comprise a retaining feature to help prevent the device from becoming displaced.
  • the retaining feature may be a corrugated outer surface for enhanced grip with the ocular layer(s).
  • the elongate structure may have a screw thread configuration to allow to the device to be more securely fixed in the eye.
  • the sleeve may additionally or alternatively have a retaining structure with an outer surface comprising angled protrusions, in the form of a plurality of feet, flaps or wings, evenly spaced in a circumferential manner or a single angled annular flap which may permit the device to be inserted though the cornea, or other structure of the eye, and which may temporarily retain the device in the inserted position thereafter by resting against an inner domed surface of that structure, such as the cornea.
  • the structure of the device comprises walls which range from 0.0001mm to 5mm in thickness.
  • the device may preferably be formed from a material biocompatible with ocular tissue such as plastics or silicone, including grade a silicone.
  • materials include but are not limited to medical grade silicone, silicone polymer, silicone rubber, rubber, latex, Teflon, polypropylene, nylon, plastic and thermoplastic polyurethanes.
  • the device further comprises a base section at a proximal end.
  • the base section further comprises one or a plurality of internal channels connected with the exit apertures to improve fluid flow from the annular space at the proximal end of the device. Said multiplicity of channels can serve to provide optimal irrigation and balancing of IOP functioning to promote effective drainage.
  • the one or more further internal channels may provide different functionality, so the device is adapted to permit efficient release of gas or fluids of differing viscosity, in addition to the removal of excess physiological fluid, such as balanced salt solution, isotonic saline or viscoelastic fluid such as sodium hyaluronate, hypromellose.
  • the invention relates to use of the device, in a hydro-dissection or other step of phacoemulsification surgery, angle surgery such as schlemm canal or trabecular surgery including stents, implants or vitreoretinal surgery.
  • the invention relates to use of the device in a method of controlling intraocular pressure during ophthalmological surgery to the eye.
  • the invention concerns a method of maintaining an intraocular pressure in the range of 3 to ⁇ 30mmHg during surgery to the eye comprising use of the device of the invention.
  • the present invention further concerns a method of surgical cataract removal comprising the steps of: viscoelastic insertion, capsulorhexis, hydrodissection; intraocular lens insertion; phacoemulsification; irrigation; lens aspiration and viscoelastic fluid removal, wherein during one or more of the above steps the device as previously described, is used to balance intraocular pressure throughout the removal.
  • the invention relates to use of the device or any embodiment thereof, in ocular surgery and in particular in cataract surgery including phacoemulsification surgery.
  • Figure 1 illustrates a first aspect of the invention in which the device includes a sleeve and integrated cannula and is positioned relative to the structure of the eye;
  • Figure 2 is a schematic representation of invention according a further aspect of the invention wherein the cannula is not necessarily inherently integrated but combined with the sleeve during use.
  • the advantages is still obtained.
  • the invention of the applicant also covers the embodiment in which a basic compressible device in accordance with the many embodiments hereinbefore described as 1 may be utilised with a cannula, for example, as a flexible sleeve surround 29 as shown in Figure 2.
  • the sleeve/basic device may be selected to retro-fit the desired cannula to create a hydrodissection device in situ.
  • the hydrodissection sleeve cannula can be attached / detached to the syringe.
  • Figure 1 shows device 1 or 20 with proximal and distal ends, 23 and 25 in accordance with a further aspect of the present invention.
  • a device comprises a central shaft 21.
  • the device typically comprises a fluid injection means or apparatus 27 at the proximal end 23 of the device for inserting fluid into the ocular space during surgery.
  • the device further includes a flexible sleeve surround 29, wherein the sleeve comprises at least one entry aperture(s) 30s at the distal end to permit excess fluid or liquid in the ocular space to enter the annular space 40 in the device to exit therefrom via exit aperture 30b at a base 33 of the device.
  • a simplistic illustration of the movement of fluid F is shown by arrows when the device is utilised in surgery of the eye E.
  • the device in combination therefore usefully provides both the function of introducing the fluid necessary for hydrodissection step of surgery and still solves the technical problem relating to IOP build up.
  • the cannula end permits ease of entry when inserting the device into the eye.
  • Such a configuration may in particular allow the surgeon to make a micro incision with the device itself, hence dispensing for the need of an additionally pre-made incision with a different tool.
  • the liquid can be introduced via a syringe 27, but another injection device, for example, a hose connection, is conceivable.
  • the fluid F flows down the shaft 21 of the cannula and into the eye, where after, any excess fluid Fl is enabled to return from under the iris back into the device via the aperture 30a in the removable device escaping the ocular space, avoiding IOP from rising.
  • the excess fluid/gas may include more than one physiological/non- physiological fluid or gas.
  • viscoelastic fluid is needed in the procedure during introduction of a new lens into the eye.
  • a lens injector filled with such fluid and a lens and injected in a closed system necessarily raises the pressure in the eye further.
  • the invention is equally useful here; this additional fluid may also be safely removed by the same mechanism but this time different channels in the base of the device are effectively used to balance pressure.

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)

Abstract

L'invention concerne un dispositif ophtalmologique destiné à la réalisation d'une chirurgie oculaire, en particulier une chirurgie de la cataracte, y compris une hydrodissection et/ou une hydrodilatation. L'invention concerne un dispositif ophtalmologique éventuellement intégré à une canule d'hydrodissection ou à un injecteur de lentille, c'est-à-dire que le dispositif peut être monté sur l'instrument si nécessaire ou l'invention peut incorporer l'instrument lui-même, c'est-à-dire un dispositif ophtalmologique comprenant une canule et/ou un injecteur intégrés. Le dispositif ophtalmologique ici divulgué comprend un manchon allongé souple destiné à assurer un joint périphérique avec une ou plusieurs couches oculaires, le manchon étant conçu pour entourer une grande partie d'une canule, éventuellement intégré à cette dernière, pour définir un espace annulaire allongé entre le manchon et la canule, le manchon comprenant au moins un point d'entrée fluidique situé de manière distale et au moins un point de sortie fluidique situé à proximité, éloigné dans l'espace du point d'entrée sur une longueur du manchon. L'invention permet donc de gérer efficacement la pression intraoculaire puisque le fluide intraoculaire dans l'œil peut accéder à l'espace annulaire du dispositif au niveau de l'extrémité distale, traversant le dispositif par la longueur de l'espace annulaire et être émis à partir de ce dernier.
PCT/GB2021/052963 2020-11-16 2021-11-16 Dispositif ophtalmologique et instrument WO2022101648A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202180090825.5A CN116801848A (zh) 2020-11-16 2021-11-16 眼科设备和仪器
EP21814851.8A EP4243747A1 (fr) 2020-11-16 2021-11-16 Dispositif ophtalmologique et instrument

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB2018011.3A GB2601298A (en) 2020-11-16 2020-11-16 Ophthalmological device and instrument
GB2018011.3 2020-11-16

Publications (1)

Publication Number Publication Date
WO2022101648A1 true WO2022101648A1 (fr) 2022-05-19

Family

ID=74046694

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2021/052963 WO2022101648A1 (fr) 2020-11-16 2021-11-16 Dispositif ophtalmologique et instrument

Country Status (4)

Country Link
EP (1) EP4243747A1 (fr)
CN (1) CN116801848A (fr)
GB (1) GB2601298A (fr)
WO (1) WO2022101648A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5562612A (en) * 1995-02-02 1996-10-08 Charles D. Kelman Apparatus and method for reverse flow irrigation and aspiration of interior regions of the human eye
WO2018178658A1 (fr) 2017-03-31 2018-10-04 Anant Sharma Dispositifs intraoculaires et procédés associés
US20200306084A1 (en) * 2019-03-28 2020-10-01 Universidad De Los Andes Device and method for fracturing and removing ocular lenses

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011012637B4 (de) * 2011-02-28 2017-03-09 Geuder Ag Hülle für ein medizinisches Instrument
US10596033B2 (en) * 2012-03-26 2020-03-24 Alex Urich Phacoemulsification ultrasonic device switching between different operational modes
CN206414391U (zh) * 2016-08-31 2017-08-18 南京市鼓楼医院 一种吸附式超声乳化机头及超声乳化设备
KR101945992B1 (ko) * 2017-01-23 2019-02-08 재단법인 아산사회복지재단 초음파 유화 흡입술용 관류 슬리브

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5562612A (en) * 1995-02-02 1996-10-08 Charles D. Kelman Apparatus and method for reverse flow irrigation and aspiration of interior regions of the human eye
WO2018178658A1 (fr) 2017-03-31 2018-10-04 Anant Sharma Dispositifs intraoculaires et procédés associés
US20200306084A1 (en) * 2019-03-28 2020-10-01 Universidad De Los Andes Device and method for fracturing and removing ocular lenses

Also Published As

Publication number Publication date
CN116801848A (zh) 2023-09-22
GB202018011D0 (en) 2020-12-30
EP4243747A1 (fr) 2023-09-20
GB2601298A (en) 2022-06-01

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