GB2601298A

GB2601298A - Ophthalmological device and instrument

Info

Publication number: GB2601298A
Application number: GB2018011.3A
Authority: GB
Inventors: Sharma Anant
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-11-16
Filing date: 2020-11-16
Publication date: 2022-06-01
Also published as: WO2022101648A1; CN116801848A; GB202018011D0; EP4243747A1

Abstract

An ophthalmological device for eye surgery, comprising an elongate flexible sleeve 29 for making a peripheral seal with ocular layer(s), the sleeve adapted to surround an optionally integrated cannula 21 and define an elongate annular space between the sleeve and the cannula, wherein the sleeve comprises spatially distanced distally 23 located fluidic entry point(s) and proximally 25 located fluidic exit point(s). The cannula may extend a short distance beyond the distal end of the sleeve. The sleeve may comprise a retaining feature to prevent it being displaced during use. The sleeve may comprise a biocompatible material. The device may comprise a base section 33 at the proximal end that may comprise internal channels 30b connected to the fluid exit apertures. Methods of using the claimed device to control pressure in the eye during phacoemulsification surgery for the treatment of cataracts. A method of surgical cataract removal.

Description

Intellectual Property Office Application No G1320180113 RTM Date:25 March 2022 The following terms are registered trade marks and should be read as such wherever they occur in this document: Teflon Intellectual Property Office is an operating name of the Patent Office www.gov.uk/ipo Ophthalmological device and instrument

Introduction

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.

Background of the invention

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).

De-risking the steps in cataract removal and techniques performed in other delicate eye surgeries are crucial to advancing this surgical field. Improvements, in cataract surgery particularly, are both technically challenging and commercially valuable; some severe complications, such as central visual loss following cataract surgery are not yet fully evaluated. Thus, understanding and controlling those factors which play a part in complications of this type of surgery remain of considerable interest.

During this procedure the surgeon must detach the lens from the capsular bag during "hydro-dissection" or "hydro-dilation" where a cannula is inserted between the lens and the capsular bag and a liquid saline solution is introduced.

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).

Rises in Intraocular pressure (10P) are common, even after the hydrodissection step, continue to present a problem for some patients and therefore mitigating such a risk is challenging for surgeons.

Techniques to reduce complications have been suggested in the art, for example, in WO 2018/178658. 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.

However, change in 10P during cataract surgery is remains an important and common problem since 10P rise can exacerbate/cause post-surgical complication and result in vision loss. Devices which help manage or reduce the risk associated with ophthalmic surgery, such as cataract surgery, remain desirable.

Summary of the invention

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.

In embodiments the distal end of the device maybe arranged to facilitate penetration through the layer(s) of the eye. For example, 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. For example, after placing the device and initiating hydrodissection, 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. In particular, 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 10P. 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". When intraocular pressure rises, 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. In this way, an inherent valve may operate by virtue of the pressure differential. There may additionally be protrusions in the direction of the cannula or a change in the material properties in order to prevent in these areas the sleeve from being pressed against the cannula by surrounding tissue in such a way that the annular channel is biased closed. Alternatively or additionally 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). In other embodiments 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.

In some embodiments 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. Such materials include but are not limited to medical grade silicone, silicone polymer, silicone rubber, rubber, latex, Teflon, polypropylene, nylon, plastic and thermoplastic polyurethanes.

In embodiments, the device further comprises a base section at a proximal end. In some embodiments 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 10P 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.

In a further aspect 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.

In another aspect the invention relates to use of the device in a method of controlling intraocular pressure during ophthalmological surgery to the eye.

In a further aspect 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.

In particular, 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.

In another aspect the invention relates to use of the device or any embodiment thereof, in ocular surgery and in particular in cataract surgery including phacoemulsification surgery.

Description

Various features, embodiments and examples of the presently disclosed invention including the device, methods will now be described herein with reference to the accompanying figures wherein: 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; and 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.

It should be noted that the same elements are provided with the same reference symbols in the figures. In order to improve clarity, not every element is necessarily provided with a reference symbol.

As shown in Figure 1, whether integrated with an instrument such as a cannula, or wherein the sleeve 29 is to be integrated with the cannula of a hydrodissection device (shown before integration in Figure 2), 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. In such embodiments 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. Such 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 10P build up.

In such embodiments 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. During use of the surgical apparatus during hydro-dissection, 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 10P from rising. The fluid travels back up within the annular space of the device and can exit via one or more exit aperture 30b in the proximal end 23 of the device.

In other embodiments the excess fluid/gas may include more than one physiological/nonphysiological fluid or gas. For example, 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. However, 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.

The above-described embodiments of the device according to the invention serve only to explain the teaching but do not restrict the scope claimed.

Claims

Claims: 1. An ophthalmological device comprising 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.
2. The device according to claim 1, wherein the cannula extend a short distance beyond a distal end of the sleeve.
3. The device according to any preceding claim, wherein the sleeve is flexible and comprises a proximal end and a distal end.
4. The device according to any preceding claim, wherein the sleeve further comprises a retaining feature to help prevent the device from becoming displaced during use.
S. The device according to any preceding claim, wherein at least the sleeve comprises material biocompatible with ocular tissue such as plastics or silicone, including grade a silicone.
6. The device according to any preceding claim, wherein the further comprises a base section at a proximal end.
7. The device according to claim 6, wherein 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.
8. Use of the device in accordance with any previous claim, in phacoemulsification surgery for the treatment of cataracts.
9. Use of the device in accordance with any previous claim, in a method of controlling intraocular pressure during ophthalmological surgery to the eye.
10. Use of the device in accordance with any previous claim, in a method of maintaining an intraocular pressure in the range of 3 to<38mmHg during surgery to the eye.
11. 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 according to any previous claim used to control intraocular pressure throughout the removal.