CA2468444A1

CA2468444A1 - Eye speculum

Info

Publication number: CA2468444A1
Application number: CA002468444A
Authority: CA
Inventors: Paul Sinding
Original assignee: Fulcrum Medical Devices Ltd
Current assignee: Individual
Priority date: 2001-12-10
Filing date: 2002-12-10
Publication date: 2003-07-03
Also published as: WO2003053229A2; GB2382779A; AU2002352363A1; AU2002352363A8; GB2382779B; WO2003053229A3; EP1453421A2; GB0129521D0; JP2005512662A

Abstract

An eye speculum comprising a moulded flexible shell (2,5) configured for insertion into an eye socket so as to contact and envelop part of an eyeball , the shell (2,5) having an opening (3) therein to provide access to the eyeba ll for ocular surgery or examination.

Description

Eye Speculum Description The present invention relates to an eye speculum used by ophthalmologists during micxosurgical procedures to retract and retain the eyelids away from the surface of the eyeball.
In the field of ocular surgery, one of the most common operations is the removal of cataracts, and currently around 179,000 are performed each year in the UK.
During 70 these and other eye operations, the patient's eyelids are held apart using an eye speculum to expose the surface of the eye in the region of the pupil and iris to enable the required surgical procedure to be performed.
The majority of conventional eye speculums have a pair of metal blades each of which is mounted on the end of a wire arm. Alternatively, the speculum is formed entirely of wire, the blades being replaced with integrally formed wire loops at the end of each arm. A blade ox wire loop on each arm is hooked around or otherwise engages the upper and lower eyelid respectively to retract the eyelids. The opposite ends of each arm are connected together so that spring tension between the arms holds the blades or loops apart. The surgeon squeezes the arms together against the biasing force during insertion of the blades or loops and then releases them so that the spring tension forces the eyelids open. Alternatively, the angular relationship of the arms can be controlled via a complicated mechanical linkage.
A disadvantage with conventional eye speculums, such as those described above, is that they provide little or no stability to the eyeball, they exert excessive pressure to the eyelids in the region of contact of the speculum, they axe difficult to insert and axe uncomfortable for the patient. Furthermore, due to the materials from which conventional speculums are made, they can cause abrasion and injury to the eye socket and surrounding tissue during insertion or after prolonged use. They also tend to be expensive to manufacture so there is a reluctance to dispose of them after each use, the majority of speculums being sterilised and used again for this reason.

It is an object of the invention to provide an eye speculum that overcomes or substantially alleviates the disadvantages with conventional speculums described above.
According to the present invention, there is provided an eye speculum comprising a moulded flexible shell configured for insertion into an eye socket so as to contact and envelop part of an eyeball, the shell having an opening therein to provide access to the eyeball for ocular surgery or examination.
Preferably, the shell comprises a waist region forming the periphery of the opening and a flared skirt depending from the waist region.
The flared skirt is preferably part spherical in shape. The skirt and eyeball together form a "ball and socket" type joint that provides stability to the eyeball.
Conveniently, at least one aperture is formed in the flared skirt. This allows fluids to pass through the skirt and around the eyeball to prevent it from drying out.
20 In one embodiment, the waist portion and the flared skirt are C-shaped.
This makes the speculum even more flexible for ease of insertion.
The waist region and flared skirt may be integrally formed.
25 Preferably, the waist region comprises an annular strengthening ring.
In one embodiment, the annular strengthening ring is separable from the flared skirt and may advantageously carry graphical markings indicating angular degree increments around the periphery of the opening.
In an alternative embodiment, a strengthening ring may be concealed within the waist region.

Preferably, at least one conduit extends from the waist region to the inner surface of the flared skirt for the passage of fluid to the eyeball through the speculum.
Advantageously, the inner surface of the skirt includes at least one capillary channel extending from the conduit to draw fluid away from the conduit.
In any of the preferred embodiments, eyelid retaining members upstand from the waist member and may comprise a pair of arcuate flanges or wings, or two groups of spaced fingers.
The conduit may extend through the eyelid retaining members.
In another embodiment, the waist region includes at least one arcuate sleeve that extends partially around the periphery of the opening, an end of the or each sleeve being open to receive and mount a removable handle to the speculum.
Preferably, the or each sleeve is partially open along its length to form a channel.
The speculum may additionally comprise a handle member having a portion 20 configured for insertion into the or each sleeve to removably mount the handle thereto and a body portion for holding the speculum.
The body portion of the handle preferably extends laterally from the speculum in the plane of the waist region.
In a preferred embodiment, the waist region includes a pair of sleeves and the handle is two forked arms, the end of each arm being inserted into a respective sleeve to mount the handle to the speculum, said arms being flexible to allow the speculum to be deformed during insertion by squeezing said arms together.
The speculum is preferably moulded from plastic or silicon rubber.

As the speculum of the present invention is cheap to manufacture in comparison with conventional speculums, it may be thrown away after a single use thus avoiding the requirement to sterilise them. This is a particularly significant advantage as known sterilisation processes are not 100% effective and is even more important with the occurrence of vCJD (the human form of mad cow disease) and the possibility of cross-tool contamination widely acknowledged as a problem with the sterilisation of non-disposable surgical tools.
Embodiments of the present invention will now be described, by way of example 70 only, with reference to the accompanying drawings, in which:-FIGURE 1 shows an eye speculum according to a first embodiment of the present invention;
FIGURE 2 shows a modified version of the eye speculum of the first embodiment incorporating irrigation or anaesthetic conduits;
FIGURES 3 and 4 show two further modifications of the first embodiment;
FIGURE 5a show two cross-sectional views through the eye speculum of Figure 1;
FIGURE 5b shows two cross-sectional views through the eye speculum of Figure 2;
FIGURE 5c shows two cross-sectional views through an eye speculum according to a second embodiment;
FIGURE 5d shows two cross-sectional views through an eye speculum according to a third embodiment;
FIGURE 6 shows an eye speculum according to a fourth embodiment;
FIGURE 7 shows the eye speculum of Figure 1 mounted on an eyeball;
FIGURE 8 shows an eye speculum according to a fifth embodiment;
FIGURE 9 shows the wire handle shown in Figure 8;
FIGURE 10 shows a modified version of the fifth embodiment illustrated in Figure 8;
FIGURE 11 shows a C-shaped speculum with an integral eye drape, and FIGURE 12 shows a non C-shaped or closed type speculum with an integral eye drape.
Referring now to the drawings, there is shown in Figure 1, an eye speculum 1 according to a first embodiment of the present invention in the form of a moulded flexible shell comprising a waist portion 2 forming the periphery of an opening 3 and incorporating a stiffening or rigidifying ring 4 only the upper surface 4a of which is visible, and a flared skirt portion 5 which is part spherical in shape and has a concave inner wall 6. Optional flanges 7 to assist in retaining the eyelids and/or 5 eyelashes away from the eye upstand from the waist portion 2. The skirt 5, waist portion 2 and the flanges 7 are integrally formed from a resilient moulded flexible material such as silicon rubber.
A modified version of the first embodiment is illustrated in Figure 2. The eye 70 speculum 1 of this version is additionally provided with an irrigation tube or conduit 9 extending through each of the flanges 7 to an outlet 8 in the inner wall 6 of the skirt 5. A capillary channel 10 extends away from the outlet 8 to draw fluid away from the outlet 8 and over the surface of the eyeball beneath the skirt 5.
Alternatively, the conduit 9 can be used for the insertion of a curved needle often 75 used by surgeons during ocular surgery to apply anaesthetic to a region toward the rear of the eyeball.
Two further modified versions of the eye speculum 1 shown in Figure 1 are illustrated in Figures 3 and 4. In Figure 3, the flanges 7 have been replaced by a pair 20 of open loops or frames 11, and in Figure 4, the flanges 7 have been replaced with two sets of fingers 12.
Figure 5a shows two cross-sections through the eye speculum 1 shown in Figure 1.
The position of the stiffening ring 4 embedded within the mould can be seen in the 25 waist region 2. In Figure 5b, which shows two cross-sectional views of the speculum 1 shown in Figure 2, the path of the irrigation conduits 9 are clearly visible and it will be appreciated that the conduit 9 passes through the stiffening ring 4, an aperture being provided in the stiffening ring 4 for this purpose.
In the embodiment of Figure 5c, the stiffening ring 4 and the flanges 7 are integrally 3o formed, the ring 4 and flanges 7 being co-moulded with the skirt 5. The skirt 5 may be formed from a different, softer or more flexible material than the ring 4 and flange 7 so that it flexes and conforms more easily to the shape of the eyeball.
Figure 5d' shows a speculum Which is similar to the speculum illustrated in Figure 5c, except that the integrally formed ring 3 and flanges 6 axe a snap fit with the skirt formed as an entirely separate component. Lugs or bosses 13 are formed on one part, which engage with corresponding recesses in the mating part.
5 Figure 6 illustrates another embodiment in which an opening 14 extends through each flange so that irrigation tubes 15 can be connected thereto and irrigating fluid, indicated by "A" on the figure, fed through the tubes and openings 14 onto the front face of the eyeball to prevent it from drying out during surgery.
70 Figure 7 shows the eye speculum according to the invention mounted on an eyeball 16. The surgeon may work on the iris or pupil through the opening 2a whilst the eyelids and eyelashes are held in a retracted position by the speculum 1.
Another embodiment of speculum according to the invention is shown in Figure 8.
75 In this embodiment, the speculum 18 is C-shaped to enable it to be flexed more easily during insertion. As it does not completely surround the eyeball 16, it also may cause less trauma or discomfort to the patient. It will be appreciated that any of the embodiments described above may also be C-shaped.
20 The speculum 18 is provided with a pair of arcuate sleeves 19 around the periphery of the opening 3 which are integrally formed on the waist region 2. Each sleeve has a central closed section 20 between two open channels 21. One end 22 of each channel 21 is open to enable insertion of the ends of a bent wire handle 23 to mount the handle 23 to the speculum 18. The speculum 18 may be used with or 25 without the handle 23 and can be easily removed. This is important as a handle 23 can often obstruct the surgeon when performing intricate eye surgery.
The handle 23 can be seen more clearly from Figure 9. It comprises a length of wire or rod bent to form a pair of identical forked arms 24. The free ends of each arm 24 30 are curved to correspond to the curvature of the arcuate sleeves 19 in the speculum 18 and have a depression 25 thereon in which the central closed section 20 of a sleeve 19 locates to mount the handle 23 to the speculum 18. It will be appreciated that the arms 24 may be squeezed together to partially squash the speculum 18 to enable insertion into the eye socket, the arms 24 returning to their normal configuration, as shown in Figures 8 and 9, when pressure applied to them is released. The ends of each arm 24 received in the sleeves 19 act as a stiffening member for the waist region 2 so the stiffening member 4 is not required in this embodiment but may still be included so that the speculum can be used without the handle 23.
Figure 10 shows another type of C-shaped eye speculum according to an embodiment of the invention which is similar to the non C-shaped ox closed version 70 illustrated in Figure 1 although a portion of the flanges 7 fox retaining the eyelids and holding the eyelashes out of the way are partially cut away to form two flange portions 7a, 7b. The embodiment of Figure 10 may be provided with means to enable the wire handle of Figure 8 to be attached and/or have irrigation tubes or conduits such as the embodiment of Figure 2.
Figure 11 illustrates another C-shaped speculum which incorporates an integral eye drape 30 that extends angulaxly away from the waist region 2 or stiffening ring 4.
This omits the need for the surgeon to mask the eye with a secondary drape during a surgical procedure.
Figures 12 and 13 show a top and bottom perspective view respectively, of how an integral eye drape 31 may be incorporated into one of the non-C shaped or closed ring eye-speculums such as those described in more detail above.
The present invention provides an eye speculum that is cheap to manufacture and easier to use than those currently available. It is also more comfortable for the patient and provides stability to the eyeball.
Many modifications and variations to the invention falling within the terms of the following claims will be apparent to those skilled in the art and the foregoing description should be regarded as a description of the preferred embodiments only.

Claims

1. An eye speculum comprising a moulded flexible shell configured for insertion into an eye socket so as to contact and envelop part of an eyeball, the shell having an opening therein to provide access to the eyeball for ocular surgery or examination.

2. An eye speculum according to claim 1, wherein the shell comprises a waist region forming the periphery of the opening and a flared skirt depending from the waist region.

3. An eye speculum according to claim 2, wherein the flared skirt is part spherical in shape.

4. An eye speculum according to claim 2 or claim 3, wherein at least one aperture is formed in the flared skirt.

5. An eye speculum according to any of claims 2 to 4, wherein the waist portion and the flared skirt are C-shaped.

6. An eye speculum according to any preceding claim, wherein the waist region and flared skirt are integrally formed.

7. An eye speculum according to any of claims 1 to 5, wherein the waist region comprises an annular strengthening ring.

8. An eye speculum according to claim 7, wherein the annular strengthening ring is separable from the flared skirt.

9. An eye speculum according to claim 7 or claim 8, wherein the strengthening ring carries graphical markings indicating angular degree increments around the periphery of the opening.

10. An eye speculum according to claim 6, wherein the waist region includes a strengthening ring concealed within the waist region.

11. An eye speculum according to any preceding claim, wherein at least one conduit extends from the waist region to the inner surface of the flared skirt for the passage of fluid to the eyeball through the speculum.

12. An eye speculum according to claim 11, wherein the inner surface of the skirt includes at least one capillary channel extending from the conduit to draw fluid away from the conduit.

13. An eye speculum according to any preceding claim, wherein eyelid retaining members upstand from the waist member.

14. An eye speculum according to claim 12, wherein the eyelid retaining members comprise a pair of part arcuate flanges.

15. An eye speculum according to claim 13, wherein at least one aperture is formed in and extends through each flange.

16. An eye speculum according to claim 13 when dependent on claim 10 or 11, wherein the conduit extends through the eyelid retaining members.

17. An eye speculum according to claim 13, wherein the eyelid retaining members comprises two groups of spaced fingers.

18. An eye speculum according to any of claims 2 to 17, wherein the waist region includes at least one arcuate sleeve that extends partially around the periphery of the opening, an end of the or each sleeve being open to receive and mount a removable handle to the speculum.

19. An eye speculum according to claim 18, wherein the or each sleeve is partially open along its length to form a channel.

20. An eye speculum according to claim 18 or 19, comprising a handle member having a portion configured for insertion into the or each sleeve to removably mount the handle thereto and a body portion to for holding the speculum.

21. An eye speculum according to claim 20, wherein the body portion extends laterally from the speculum in the plane of the waist region.

22. An eye speculum according to claim 20 or 21, wherein the waist region includes a pair of sleeves and the handle is two forked arms, the end of each arm being inserted into a respective sleeve to mount the handle to the speculum, said arms being flexible to allow the speculum to be deformed during insertion by squeezing said arms together.

23. An eye speculum according to any preceding claim, formed from moulded plastic.

24. An eye speculum according to claim 23, formed from silicon rubber.

25. An eye speculum substantially as hereinbefore described, with reference to the accompanying drawings.