CN116801848A - Ophthalmic apparatus and instrument - Google Patents

Abstract

The present application relates to an ophthalmic device for performing eye surgery, in particular cataract surgery comprising water separation and/or water expansion. The present application relates to an ophthalmic device optionally integrated with a water separation cannula or lens injector, i.e. the device may be mounted on the instrument if desired, or the present application may be combined with the instrument itself, i.e. an ophthalmic device comprising an integrated cannula and/or injector. The ophthalmic devices disclosed herein include an elongated flexible sleeve for forming a peripheral seal with one or more ocular layers, the sleeve being adapted to enclose a substantial portion of the cannula, optionally the sleeve being integrated with the cannula to define an elongated annular space between the sleeve and the cannula, wherein the sleeve includes at least one distally located fluid entry point and at least one proximally located fluid exit point spatially spaced apart from the entry point along a length of the sleeve. Thus, the present application effectively allows for management of intraocular pressure, as intraocular fluid in the eye can enter the annular space of the device distally, pass through the device via the length of the annular space, and be expelled from the device.

Description

Ophthalmic apparatus and instrument

Introduction to the application

The present application relates to a device for performing intraocular surgery including water separation (hydro-separation) and/or water expansion (hydro-displacement), in particular during cataract surgery, optionally comprising an instrument such as a cannula.

Background

Cataracts are clouding of the lens inside the eye, resulting in vision loss, and cannot be corrected without surgery because of the need to replace the lens (using an artificial lens).

Eliminating the risk of cataract removal procedures and other techniques performed in delicate eye surgery is critical to advance the art of surgery. Improvements, particularly in cataract surgery, are both technically challenging and commercially valuable; some serious complications (e.g., central vision loss after cataract surgery) have not been adequately evaluated. Therefore, it remains of great interest to understand and control those factors that play a role in this type of surgical complications.

During this procedure, the surgeon must separate the lens from the capsular bag (capsular bag) during "water separation" or "water dilation", where a cannula is inserted between the lens and capsular bag and a liquid saline solution is introduced.

Water separation is an essential step during "phacoemulsification" surgery, in which the lens is broken up and aspirated with ultrasonic instrumentation. As it allows the separation of the cortex from the ocular capsule. Spatial separation helps to more easily and more completely remove the cortex and less stress on the zonules (zonules); the annulus fibrosis connects the ciliary body with the lens of the eye. Water separation also allows nuclear mobility to aid in breaking cataracts. This surgical procedure is of great concern to the surgeon because it typically involves uncontrolled risk factors leading to one or more surgical complications. It is particularly important that when intraocular pressure increases due to the water separation wave, fluid is drained from the eye in order to prevent prolapse of the iris (where the iris pushes itself through the incision).

Intraocular pressure (IOP) elevation is common even after a water separation step, remains problematic for some patients, and thus reducing this risk is challenging for the surgeon.

Techniques to reduce complications have been proposed in the art (e.g. in WO 2018/178658). The device has a cannula surrounded by a sleeve such that an annular space is created between the cannula and the sleeve. The annular space allows fluid injected into the eye through the cannula to escape from the eye through the sleeve via an opening formed along the sleeve.

However, changes in IOP during cataract surgery remain an important and common problem, as elevated IOP can exacerbate/lead to postoperative complications and vision loss. Devices that help manage or reduce the risks associated with ophthalmic surgery (e.g., cataract surgery) remain desirable.

Summary of The Invention

The present application relates to an ophthalmic device for performing eye surgery, in particular cataract surgery comprising water separation and/or water expansion.

The present application relates to an ophthalmic device for use with a conventional water separation cannula or lens injector, i.e. the device may be mounted on the instrument if desired, or the application may be incorporated into the instrument itself, i.e. an ophthalmic device comprising an integrated cannula and/or injector.

The apparatus disclosed herein includes an elongated flexible sleeve (elongate flexible sleeve) for forming a peripheral seal with one or more ocular layers, the sleeve being adapted to enclose a majority of a cannula (optionally, the sleeve being integrated with the cannula) to define an elongated annular space between the sleeve and the cannula, wherein the sleeve includes at least one distally located fluid entry point and at least one proximally located fluid exit point spatially spaced from the entry point along a length of the sleeve. Thus, the present application effectively allows for management of intraocular pressure, as intraocular fluid in the eye can enter the annular space of the device distally, pass through the device via the length of the annular space, and be expelled from the device.

In embodiments, the distal end of the device may be arranged to facilitate penetration of one or more layers 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 may be a tubular element of almost any shape through which liquid may be introduced into the eye. The cannula may be sharp and/or sharpened at its distal end.

For example, such devices may be safely placed and/or secured across the pupil edge during cataract surgery. Techniques/operations as described during cataract removal (such as water separation) may then be performed by the surgeon with reduced risk of complications. For example, after placement of the device and initiation of water separation, any excess fluid in the eye may safely move from the interior chamber through the inlet aperture toward the distal end of the device at the working surgical site of the cataract, and will flow through the interior passage of the core structure and out the proximal end through the outlet aperture. In particular, the apparatus of the present application allows a surgeon to continue surgery in the eye with reduced attention to uncontrolled changes in IOP. The present application provides the function of introducing the fluid necessary for water separation via the cannula, but uses this structure in conjunction with other features to effectively allow excess fluid or accumulation at the surgical site, which can be drained from the eye to manage intraocular pressure.

The sleeve structure is elongated and thus shaped like a tube. The sleeve may be compressible, deformable, or otherwise malleable to ensure that the device can be easily inserted through the incision, but remain fitted (fit) with the one or more layers of the eye through which the device passes. The core structure of the device typically includes a proximal end (near the user/surgeon) and a distal end. The inlet aperture is located at the distal end of the surgeon and the outlet aperture is located at the proximal end so that the excess fluid moves away from the surgical site and out of the eye.

The material of the sleeve may be selected and the dimensions may be adjusted in such a way that the sleeve is flexibly pressed against the cannula by the surrounding ocular tissue, in particular the sclera, so that the annular space is temporarily pushed "closed". When the intraocular pressure increases, the liquid moves towards the entry point and into the sleeve so as to push against the outer wall (of the sleeve) with sufficient pressure so as to open the annular space. In this way, the inherent valve can be operated by means of a pressure difference. There may additionally be a protrusion in the direction of the cannula or a change in the material properties in order to prevent the sleeve from being pressed against the cannula in such a way that the circumferential tissue is biased closed by the annular channel in these areas. Alternatively or additionally, the sleeve may incorporate an internal one-way valve within the annular space.

The sleeve of the device may also include a retention feature to help prevent the device from being dislodged. The retention feature may be a corrugated outer surface for enhancing adherence (clip) to one or more ocular layers. In other embodiments, the elongated structure may have a threaded configuration to allow the device to be more securely fixed in the eye. The sleeve may additionally or alternatively have a retaining structure having an outer surface comprising angled projections or a single angled annular fin in the form of a plurality of feet, fins (flaps) or fins (wings) evenly spaced apart in a circumferential manner, which may allow insertion of the device through the cornea or other structure of the eye, and which may thereafter temporarily retain the device in an inserted position by abutting an inner dome surface of the structure, such as the cornea.

In some embodiments, the structure of the device includes walls ranging in thickness from 0.0001mm to 5 mm.

The device may preferably be formed of a material that is biocompatible with ocular tissue, such as plastic or silicone, including class a silicone. Such materials include, but are not limited to, medical grade silicone, silicone polymers, silicone rubber, latex, teflon (Teflon), polypropylene, nylon, plastics, and thermoplastic polyurethane.

In an embodiment, the device further comprises a proximal base section. In some embodiments, the base section further comprises one or more internal channels connected with the outlet aperture to improve fluid flow from the annular space at the proximal end of the device. The multiple channels may be used to provide a balance of optimal lavage and IOP functions to promote effective drainage (drainage). The one or more additional internal channels may provide different functions, so that the device is adapted to allow for the efficient release of gases or fluids of different viscosities in addition to removing excess physiological fluid such as balanced salt solution, isotonic saline or viscoelastic fluid such as sodium hyaluronate, hypromellose.

In another aspect, the application relates to the use of the device in the separation of water or other steps of a phacoemulsification procedure, an angle surgery (schlemm's canal) or a trabecular surgery (including stent, implant or vitreoretinal surgery).

In another aspect, the application relates to the use of the device in a method of controlling intraocular pressure during an ophthalmic procedure for an eye.

In another aspect, the application relates to a method of maintaining intraocular pressure in the range of 3mmHg to <30mmHg during surgery on an eye, the method comprising using the device of the application.

In particular, the present application also relates to a surgical cataract extraction method comprising the steps of: viscoelastic insertion, capsulorhexis and water separation; intraocular lens insertion; phacoemulsification; lavage; lens aspiration and viscoelastic fluid removal, wherein the apparatus as previously described is used to balance intraocular pressure throughout the removal process during one or more of the above steps.

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

Description of the application

Various features, embodiments and examples of the presently disclosed application including apparatus, methods will now be described herein with reference to the drawings, in which:

FIG. 1 shows a first aspect of the application, wherein the device comprises a sleeve and an integrated cannula and is positioned relative to the structure of the eye; and

fig. 2 is a schematic representation of the present application according to another aspect thereof, wherein the cannula does not have to be inherently integrated with the sleeve during use, but is combined with the sleeve.

It should be noted that in the figures, like elements are provided with like reference numerals. Not every component may be necessarily provided with a reference numeral in order to improve clarity.

As shown in fig. 1, advantages are still obtained whether integrated with an instrument such as a cannula or wherein the sleeve 29 is to be integrated with the cannula of the water separation device (before integration is shown in fig. 2). The inventors' application also contemplates embodiments wherein a substantially compressible device according to many of the embodiments previously described as 1 may be used with a cannula, for example, as a flexible sleeve surround 29 as shown in fig. 2. In such embodiments, the sleeve/base device may be selected to modify the cannula as needed to create the water separation device in situ. The water separation sleeve cannula may be attached/detached from the syringe.

Fig. 1 shows a device 1 or 20 according to another aspect of the application having a proximal end 23 and a distal end 25. Such a device comprises a central shaft 21. The device generally includes a fluid injection means or instrument 27 at the proximal end 23 of the device for inserting fluid into the ocular space during surgery. The device further comprises a flexible sleeve surround 29, wherein the sleeve comprises at least one inlet hole 30s at the distal end to allow excess fluid or liquid in the eye space to enter an annular space 40 in the device to be expelled from the device via an outlet hole 30b at the base 33 of the device. When the device is used in the surgery of the eye E, a simplified illustration of the movement of the fluid F is shown by the arrows. Thus, the combined device effectively provides the function of introducing the fluid necessary for the surgical water separation step and also solves the technical problems associated with IOP accumulation.

In such embodiments, the cannula end allows easy access when inserting the device into the eye. Such a configuration may particularly allow the surgeon to make micro-incisions using the device itself, thus obviating the need for additional pre-made incisions using different tools. During use of the surgical instrument during water separation, liquid may be introduced via the syringe 27, but another injection device (e.g., a hose connection) is envisioned. Fluid F flows down the cannula's axis 21 and into the eye, after which any excess fluid F1 can be returned from under the iris into the device via the hole 30a in the removable device, escaping the ocular space, thereby avoiding an elevation of IOP. The fluid flows back up the annular space of the device and may be expelled through one or more outlet holes 30b in the proximal end 23 of the device.

In other embodiments, the excess fluid/gas may include more than one physiological/non-physiological fluid or gas. For example, during the introduction of a new lens into the eye, a viscoelastic fluid is required during surgery. A lens injector filled with such fluid and lens and injected in a closed system will necessarily further increase the pressure in the eye. However, the application is equally useful herein; this additional fluid can also be safely removed by the same mechanism, but a different channel of the base of this time the device is effectively used to balance the pressure.

The above-described embodiments of the apparatus according to the present application are only intended to illustrate the teachings and not to limit the scope of what is claimed.

Claims (11)

1. An ophthalmic device comprising an elongate flexible sleeve for forming a peripheral seal with one or more ocular layers, the sleeve being adapted to enclose a substantial portion of a cannula, optionally the sleeve being integrated with the cannula to define an elongate annular space between the sleeve and the cannula, wherein the sleeve comprises at least one distally located fluid inlet point and at least one proximally located fluid outlet point, the outlet point being spatially spaced apart from the inlet point along the length of the sleeve.

2. The apparatus of claim 1, wherein the cannula extends a short distance beyond the distal end of the sleeve.

3. The apparatus of any preceding claim, wherein the sleeve is flexible and comprises a proximal end and a distal end.

4. The device of any preceding claim, wherein the sleeve further comprises a retaining feature to help prevent the device from being dislodged during use.

5. The device of any preceding claim, wherein at least the sleeve comprises a material that is biocompatible with ocular tissue, such as plastic or silicone comprising a-grade silicone.

6. The device of any preceding claim, wherein the device further comprises a proximal base section.

7. The apparatus of claim 6, wherein the base section further comprises one or more internal channels connected with an outlet aperture to improve fluid flow from the annular space at the proximal end of the apparatus.

8. Use of the device according to any preceding claim in phacoemulsification surgery for treating cataract.

9. Use of the device according to any preceding claim in a method of controlling intraocular pressure during an ophthalmic procedure for an eye.

10. Use of the device of any preceding claim in a method of maintaining intraocular pressure during surgery on an eye in the range 3mmHg to <30 mmHg.

11. A method of surgical cataract extraction comprising the steps of: viscoelastic insertion, capsulorhexis and water separation; intraocular lens insertion; phacoemulsification; lavage; lens aspiration and viscoelastic fluid removal, wherein, during one or more of the above steps, the device according to any preceding claim is used to control intraocular pressure throughout the removal process.