INTRAOCULAR DEVICES AND METHODS

Abstract

The present application relates to novel intraocular devices and their use in surgical techniques, as well as the novel surgical methodology achieved from their use.

Claims

1-20. (canceled)

21. A device for use in cataract surgery and post-operative surgical care comprising: a solid core structure adapted to form a peripheral seal with one or more ocular layers about the device in-situ, the structure comprising a proximal end and a distal end and at least one internal channel connecting the ends, permitting at least one of a fluid or gas to pass through the device and balance intraocular pressure, and the device further comprises at least one valve positioned within the internal channel of the core structure which enhances or promotes movement of physiological fluid out of the eye when the intraocular pressure is raised.

22. The device of claim 21, wherein the core structure is compressible, deformable or flexible.

23. The device of claim 21, wherein the device has a length in the range of 0.01 mm to 50 mm and the structure is elongate.

24. The device of claim 21, wherein the core structure further comprises a retaining feature selected from: a corrugated outer surface, a screw thread configuration, angled protrusions, in the form of a plurality of feet, flaps or wings evenly spaced in a circumferential manner or an angled annular flap.

25. The device of claim 21, wherein the core structure of the device is circular or ellipsoid in cross-section, and/or wherein the device has an average cross-section ranging from 0.001 mm to 15 mm in size.

26. The device of claim 21, wherein the diameter of the cross-section has a sliding gradient and tapers toward the distal end of the structure.

27. The device of claim 21, wherein an edge of the distal end is bevelled, chiseled or sharpened.

28. The device of claim 21, wherein the device is formed from one or more materials biocompatible with ocular tissue, comprising to medical grade silicone, silicone polymer, silicone rubber, rubber, latex, Teflon, polypropylene, nylon, plastic, thermoplastic polyurethanes and biodegradable dissolvable material.

29. The device of claim 21, wherein the structure of the device comprises an annular flange at the proximal end of the core structure.

30. The device of claim 21, wherein the structure of the device comprises a plurality of internal channels.

31. The device of claim 21, wherein the internal channel or channels of the device further comprises one or more grooves or a plurality of valves comprising as one-way, pre-set and/or pressure valves.

32. The device of claim 21, configured to be a removable attachment with a shaft of an ocular surgical apparatus, wherein the internal channel of the device is adapted to form a seal with the shaft and the core structure further comprises a plurality of apertures there-along.

33. The device of claim 21, wherein it is configured for use in cataract surgery to control intraocular pressure.

34. The device of claim 21, wherein intraocular pressure is maintained in the range of 3<30 mmHg during surgery.

35. A method of surgical cataract removal comprising the steps of: 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 claim 21 is inserted and used to continually balance intraocular pressure throughout the removal.

36. The method of claim 35, wherein the device is temporarily retained in the eye, post cataract removal.

Description

BRIEF DESCRIPTION

[0052] 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:

[0053] FIG. 1 illustrates a first aspect of the device of invention positioned relative to the structure of the eye;

[0054] FIG. 2 illustrates an embodiment of the invention;

[0055] FIG. 3 illustrates a further embodiment of the device of the invention;

[0056] FIG. 3a illustrates a number of further embodiments of the device;

[0057] FIG. 4; illustrates a further aspect of the invention in which a surgical apparatus such as a hydrodissector incorporates a device; and

[0058] FIG. 5; illustrates embodiments in which device of the invention when used in combination with an instrument of surgery is either removable or integrated with an instrument used in ocular surgery.

DETAILED DESCRIPTION

[0059] As used herein, the term proximal refers to the end of the apparatus or feature which is closer to the user or clinician and the term distal refers to the end of the apparatus which is relatively speaking distanced from the user as compared to the proximal end.

[0060] Variations of the presently disclosed device are possible and within the scope of the present disclosure provided the major features of the invention are present, as defined by the claims.

[0061] In FIG. 1 the device of the invention is shown in-vivo as would be seen according to a rough cross-section of the structure of the eye. In this embodiment the device is positioned during ocular surgery, in particular during a cataract removal procedure, for example. However, the device in any of the examples described, wherein it is not permanently part of a larger surgical device such as a hydro-dissector or lens injector, could equally remain in place postoperatively. Alternatively, the device shown could be inserted purely for IOP care or maintenance, in order to obtain the effect, without having been directly used during formal surgery, per se.

[0062] During hydrodissection step of cataract removal, the surgeon must insert a hydrodissection cannula HDC through the cornea, as shown in the figure. After capsulorhexis, the device 1 of the invention will be inserted at different location.

[0063] The device 1 has a deformable core, or central structure, shown as section 3. When inserted in to the eye, the core compresses and its external surface adapts with the ocular structure surface such as the cornea C, through which it is passed, forming a peripheral seal therewith. The core structure has a distal end 5 and a proximal end 7, with an internal channel 8 extending there through. The device is a compressible or deformable material to enable a very small incision in the eye and yet permit the peripheral seal to be tight. The device may be formed from one or more functional material biocompatible with ocular tissue such as flexible plastic or silicone. In preferred examples, such as this, the device is formed from any material, or materials in combination, conforming to European and International regulatory requirements for surgical devices and implants.

[0064] The surgeon may make a micro incision (currently 0.5-3 mm in cataract surgery) in order to apply the device to the position shown in FIG. 1. However, the device may have features to allow for self-insertion without the need for a pre-incision. For example, in some examples or embodiments the distal end 5 may be bevelled or pointed such that the device facilitates self-insertion. In some examples, the distal end 5 may alternatively or additionally be made of a slightly harder material 5a to enable insertion with the device alone.

[0065] In the example shown, the core structure 3 with a substantially circular cross-section and the device is generally elongate with a tube or sleeve-like shape. Importantly, the selection of a particular measurement combination may be made such that the device is suitable in view of a patient's eye shape and dimension. The width or cross-section dimension of the device is typically in the range of 0.001 mm to 15 mm in size, whereas the length may range from 0.01 mm to 50 mm. The surgeon may therefore select an embodiment of the device, corresponding to a combination of the ranges, herein described, to provide a suitable patient match, especially if the device is intended to remain in the patient's eye post-surgery or inserted independently into the eye. In this regard, an embodiment of the invention concerns a provision of a device kit in which a selection of the most common combination is provided for in one useful pack.

[0066] In the example shown, the diameter of the core structure is generally constant. In this example, the core structure also comprises a corrugated section 10 (but it may be corrugated throughout). The corrugated outer surface of the structure of the device enhances grip with the corneal layer(s) and after insertion helps prevent the device from becoming displaced (during the rest of the procedure) since the structure (due to the internal pressures) may be liable to slip from the original position in a proximal direction.

[0067] Once the device is safely placed and/or secured past the pupil margin hydro-dissection may proceed. On initiating hydrodissection, any excess fluid introduced into the eye by the in the eye may safely move from the internally closed chamber at the working surgical site of the cataract towards the distal end of the device and flows (shown by the directional arrows and F) via the internal channel out the proximal end. The device therefore prevents the build-up of unwanted IOP and the full procedure of cataract removal can be carried out with reduced risk of complication that is associated with unbalanced IOP. Furthermore, since the device provides a secure seal, the eye remains expanded and does not collapse even once excess fluid has escaped from the surgical site.

[0068] As shown herein, the device enhances or promotes movement of physiological fluid out of the eye when IOP is raised. This movement is further promoted by at least one valve 9 positioned within the internal channel of the core structure; here two valves 9a, 9b are shown to regulate the movement of fluid more precisely. Such valves include one-way valves, for example. In particular, the movement of the fluid is able to be controlled and the IOP balanced even more precisely when multiple valves within the internal channel 8, in this example two, are positioned either side of the corneal wall.

[0069] A further embodiment of the device is provided in FIG. 2. Here the device of the invention is similarly constructed in its main elements as before described in FIG. 1. However, the retaining structure which secures the core structure in this example is a stabiliser 11 comprising an outer surface angled protrusion or protrusions, for example in the form of a plurality of feet, flaps or wings evenly spaced in a circumferential manner or a single angled annular flap. The stabiliser permits the device to be inserted though the cornea in the manner previously described but will act to temporarily retain the device in the inserted position specifically by resting against an inner concaved surface CSI of the cornea incision layer. The device may be retained against other layers of the eye, e.g. sclera, choroid, parsplana.

[0070] During glaucoma or combined glaucoma/cataract surgery, the device therefore acts as IOP balance mechanism but also, crucially, postoperatively functions to allow the eye to inflate if over drainage occurs.

[0071] FIG. 3 provides a further embodiment in which different types of valve may be used together to provide enhanced control of fluid movement and ease of use. In this embodiment, the device of the invention comprises an annular flange or lip 13 at the proximal end of the core structure which may sit of the surface of the cornea once the device is inserted. During insertion this feature stops the device (at the proximal end) from penetrating the cornea past beyond a maximum depth (which is pre-determined as the length of the core structure in relation to the flange is known) and lies upon an outer convex surface of the cornea CSO. The flange therefore facilitates both insertion and removal of the device. This configuration helps control and distance the device, when in situ, from the posterior surface of the cornea, especially in eyes with shallow anterior chambers thereby avoiding potential injury. In an additional embodiment the flange maybe adjustable along and temporarily fixed in place on the compressible structure 3 such the proximal end of the device protrudes therefrom (shown in dash).

[0072] The device in another embodiment, shown in FIG. 3a, may instead comprise an internal valve, in this case a spring-based valve 9c, which can be pre-set to function under particular pressure ranges. However, other valves such as more simplistic flap valves and one-way valves, such as 9a, may equally be utilised in this combination. Alternatively, such valves can be electronic and/or magnetic and control valve pressure such that they may be adjusted when device is in situ.

[0073] In addition to that configuration, in other examples, the flange may also function as a pressure valve by temporarily sealing the proximal end of the device. The flange is adapted to deform under pressure from fluid in the internal channel to create a temporary aperture at the proximal end of the device when the IOP rises and fluid moves into the internal channel.

[0074] In any case, a pressure value can pre-set such that when pressure exceeds the setting in the internal channel the valve will open to allow the fluid to escape the proximal end of the structure of the device. In particular, pre-set pressure valves allow a closed system to be retained as far as possible without risking uncontrolled rises in IOP and only one valve need be utilised for this function although they may be used in combination.

[0075] FIG. 4 shows a hydrodissection device 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 hollow annular flexible sleeve surround 29, wherein the sleeve comprises a plurality of apertures 30 spaced there along to permit excess fluid or liquid in the ocular space to re-enter the device to exit the ocular space thereby balancing intraocular pressure during surgery. A simplistic illustration of the movement of fluid F is shown by arrows when the device is utilised in surgery of the eye E.

[0076] 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 central shaft hydrodissector, for example, as the flexible sleeve surround 29 when the compressible device 1 necessarily includes a series of apertures therein (shown as 30 in the present embodiment). In such embodiments the sleeve/basic device may be selected to retro-fit the desired cannula to create a hydrodissection device. The sleeve may therefore be disposable after use with the cannula in this form. The hydrodissection sleeve cannula can be attached/detached to the syringe.

[0077] 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, but does so in a slightly different way since such a device when used with a cannula necessarily requires apertures along, whereas when used alone this feature must not be included.

[0078] In other embodiments, as shown in FIG. 5, the removable/adjustable compressible device 1 is either used with an instrument such as a cannula, or wherein the sleeve 29 is integrated with the cannula of a hydrodissection device for example. In such embodiments, the cross-section of the sleeve surround has a sliding gradient; the device 1/sleeve 29 taper towards the distal end, whereby the cross section of the distal end 25 is narrow as compared to the cross section at the proximal end 23. In such embodiments the tapered 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 edge of the distal end of the device may further be bevelled, chiseled or sharp to enhance the ease of placement. By virtue of the tapering of the sleeve, a peripheral seal with the eye is formed allowing for an improved device.

[0079] During use of the surgical apparatus, the fluid F flows down the shaft 21 of the cannula and into the eye, where after, excess fluid F is enabled to return from under the iris I back into the device via the apertures 30 in the removable device 1 or sleeve 29 thereby escaping the ocular space, avoiding IOP from rising.

[0080] In other embodiments the excess fluid/gas may include more than one physiological/non-physiological 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. In particular, the device can be placed temporarily through paracentesis when lens is being inserted to allow viscoelastic and/or other liquid already present in the ocular space to escape safely via the device 1 or sleeve 29, rather than increase the IOP beyond 30 mmHg, thereby potentially damaging intraocular structures, such as the zonules or capsule.