GB2505518A

GB2505518A - Face mounted eye light for surgery

Info

Publication number: GB2505518A
Application number: GB1215763.2A
Authority: GB
Inventors: John Greenwood
Original assignee: Individual
Current assignee: Individual
Priority date: 2012-09-04
Filing date: 2012-09-04
Publication date: 2014-03-05
Also published as: GB201215763D0; GB2519923B; GB201504374D0; GB2519923A; WO2014037708A1

Abstract

A surgical assistance device comprising 2 a frame 6 carrying a light source (12, Fig 4), the frame 6 being adapted to be attached to a human or animal patients head such that light from the light source 12 is directed in use towards an eye of said patient. The device may be attached to the patients face with adhesive 8 and the frame 6 may comprise a tripod arrangement. The device enables to patient to focus on the light 12 to fix the patients gaze whilst the surgeon operates on the other eye.

Description

OPHTHALMIC SURGERY

This invention relates to devices for assistance in carrying out ophthalmic surgery and to improved surgical methods.

Ophthalmic surgery is commonly performed for a variety of indications. Cataract surgery is the most frequently performed intraocular surgical procedure, whereby the affected lens of the patient's eye is surgically removed and replaced with an artificial lens. Cataract surgery has become routine, with some surgeons carrying out many operations every day. There has also been a vast increase in the number of refractive surgical procedures performed in recent years (i.e. surgery to correct short sight, long sight, astigmatism and presbyopia). There has been a particularly significant increase in laser refractive surgery procedures. This device has application in cataract and other intraocular surgery performed under topical anaesthesia. It also has application in laser refractive surgery and other forms of refractive surgery performed under topical anaesthesia. In the developed world, laser refractive surgery is as commonly performed as cataract surgery.

Traditionally, prior to carrying out surgery, a peribulbar or retrobulbar injection would be administered to prevent the patient suffering pain -i.e. to provide analgesia -during the procedure and also, importantly, to provide motor paralysis of the eye -known as akinesia -so that the eye would not move while the surgeon was carrying out the procedure. It has been recognised however that pen-and retrobulbar injections have been associated with rare but significant complications.

An alternative used for some time was sub-Tendons anaesthesia. This was an improvement on peribulbar injection but still with drawbacks and complications.

More recently, the employment of topical anaesthesia has been preferred since this is generally considered to be safer. It also offers a significant efficiency advantage since it is not necessary for an anaesthetist to be present during the procedure. However, the disadvantage of the topical anaesthesia approach is that it does not provide complete akinesia and thus it is necessary for the patient to maintain his or her eye in a fixed position while the procedure is carried out. The surgeon normally seeks to achieve this by asking the patient to fix the gaze of the eye being operated on on the light emitted by the operating microscope. This light is not primarily intended as a fixation source; its primary purpose is in fact to correctly illuminate the surgical field. However, this is not always easy for the patient to do and some find it more difficult than others. It is made more difficult by the fact that surgical manoeuvres can cause apparent movement of the surgical operating light to the patient and consequently involuntary movement of the patient's eye.

Any movement of the eye makes the surgical procedure more difficult for the surgeon and may increase the risk of complications. Some surgeons are discouraged from using topical anaesthesia as a result and prefer to continue with earlier techniques, such as sub-Tenons and peribulbar methods. These earlier methods can offer a greater degree of akinesia than standard topical anaesthesia, although they have a less favourable safety profile than topical anaesthetic and do not enjoy the other clinical advantages which topical anaesthesia provides.

The present invention aims to address the problems mentioned above and when viewed from a first aspect provides a surgical assistance device comprising a frame carrying a light source, the frame being adapted to be attached to a human or animal patient's head such that light from the light source is directed in use towards an eye of said patient.

The inventor has recognised that instead of asking the patient to try to keep the eye which is being operated on still, stability of the eye can instead be much more effectively achieved by providing a fixation source for the contra-lateral eye which would normally have been covered during cataract surgery. By providing a device which is directly in front of. and which provides light just into, the patient's contra-lateral eye, fixation is easily achieved. This allows all of the benefits of a topical anaesthesia to be achieved without the difficulties introduced by the mobility of the eye which is being operated on. Thus this allows greater use of topical anaesthesia and greater akinesia of the operated eye for surgeons already using the topical anaesthetic technique. The device may be covered with a surgical drape once put in place.

The frame could take many different forms and there are many different ways in which it may be attached to the subject's head. It could, for example, comprise a partial mask or hood which is fitted over the patient's head, but in a set of preferred embodiments the frame is adapted to be attached to the patient's face so that it bridges ovei the patient's contra-lateral eye. The fiame could be attached by means of a band around the patient's head or a hook e.g. over a patient's ear, but in a set of embodiments the frame is provided with an adhesive portion which is suitable for attachment to the patient's skin.

The frame could take any convenient shape although in a set of preferred embodiments it comprises a tripod arrangement to allow for stable location on a wide variety of face sizes and shapes. Conveniently, self-adhesive pads or feet are provided at the distal end of the legs of the frame.

The frame and its method of attachment should of course be such that it does not act as an impediment to the surgeon operating on the other eye.

The light source could be provided on the frame in a number of different ways. For example, it could be arranged to direct light into the eye by means of one or more reflectors. However, in a set of preferred embodiments the light source is arranged so that in use it is provided directly in front of the patient's eye. The light source is preferably a substantially point light source (e.g. less than 5 mm or less than 3 mm across) as this provides the best fixation for the eye. The light source may be provided behind an aperture or recessed into a bore in order to narrow the angle over which light is thrown. Most conveniently the light source comprises an LED.

The device may be designed so that all or part of it is reusable with suitable cleaning/sterilisation. However, conveniently, the device is adapted to be disposed after a single use. Thus, for example, it may typically comprise a sealed battery which cannot be recharged or replaced. In a set of embodiments, a pair of contacts in the electrical path between the battery and the light source is separated by a non-conductive, e.g. plastics tab which may be removed by the surgeon or surgeon's assistant immediately prior to use in order to complete the electrical circuit and activate the light source.

When viewed from another aspect the invention provides a method of surgery performed on a human or animal subject comprising directing a light source at a first, open eye of the subject and operating on a second eye of said subject.

An external light source mounted in the theatre could be used, but directed at the contra-lateral eye. In a set of embodiments of the aforementioned method, however, a device in accordance with the first aspect of the invention is used to provide the light source. This would, for example, allow the contra-lateral eye and the device to be covered with a surgical drape.

An embodiment of the invention will now be described, by way of example only, with reference to the accompanying drawings in which: Figs. 1 and 2 are two different perspective views of a surgical assistance device in accordance with the invention; Fig. 3 is a view of the device from beneath; Fig. 4 is a cross-sectional view along the line IV.. IV on Fig. 3; and Fig. 5 is a plan view showing the device in use.

With reference to Figs. ito 3, it will be seen that the surgical assistance device 2 comprises a central boss 4 from which three legs 6 extend in order to form a tripod arrangement. As may be seen particularly in Fig. 3, at the end of each leg 6 is a self-adhesive pad 8 which allows the device to be attached to a patient's skin.

In the centre of the underside of the boss 4 is an opening 10 at the end of a bore in which an LED light source 12 is received. This may be seen more clearly in the cross-section of Fig. 4. The LED i2 may, for example, be a blue LED in order to ensure that it has a distinctive colour. It will also be apparent in Fig. 4, that there is also an opening 14 at the other end of the bore, above the LED 12, which permits the LED 12 to be seen so that it may be easily verified that the device is operating correctly.

Figs. ito 4 also show a plastic tab 16 which extends inside the body of the device 2 to separate a pair of contacts (not shown) in the electrical circuit between the encased battery (also not shown) and the LED light source 12. When the tab 16 is removed, this allows the aforementioned contacts to close, thereby completing the electrical circuit and illuminating the LED 12. This provides a simple method of allowing the device 2 to be transpoited and stoied and then activated immediately prior to use without the complication of providing a switch. It also discourages re-use of the device which would risk cross-infection.

Use of the device 2 will now be described with iefeience to Fig. 5.

Once the patient is ready and in position to commence surgery, topical anaesthetic is applied to the operated eye in the usual way. The surgeon or assistant then removes the device 2 from its packaging. The plastic tab 16 is then removed and so the blue light source 12 is illuminated. Illumination can be verified by the surgeon by observing the LED through the opening 14 in the top of the boss 4. The surgeon then iemoves the protective covers from the self-adhesive feet 6 and attaches the device to the patient's face with the two upper legs attached to his forehead and the lower leg attached to his cheek as shown. The device is aftached to his face with the boss and central light source centred on the unoperated eye. Since the opening lOon the underside of the boss 4 is relatively small, the LED 12 appears as a bright, effectively point source of light to the patient. The suigeon then instructs the patient to look at the blue light continuously during the procedure. The light is sufficiently small to circumvent any focussing issues.

The device 2 is applied to the unopeiated eye plior to skin disinfection. As the device 2 is applied to the contralateral eye, it lies outside the surgical field which is normally subject to disinfection procedures with disinfection solutions. After application of the device to the contralateral side, the surgeon completes the surgical scrub procedure and begins skin disinfection procedures of the surgical field of the operated eye and surrounding tissues as normal. The surgical drapes 18 are applied as normal, and the apeitule in the diape foi the operated eye 20 is created as noimal. The device 2 fulfils a secondary purpose of keeping the suigical drape proud of the unoperated eye, preventing the drapes falling onto the operated eye 20 during surgery.

On the principle that the eyes do not move independently of one another, by maintaining fixation of the contra-lateral eye on the light source 12 visible through the opening 10, the eye 20 which is being operated on will remain stable during surgery. The surgeon can therefore conduct surgery under topical anaesthesia without difficulty since the patient is only required to focus on the clear concise target provided by the device 2. Moreover, as the patient's visualisation is not affected by surgical manoeuvres, clear fixation may be achieved with markedly improved stability of the operated eye during surgery under topical anaesthetic.

At the end of the procedure, the device 2 can simply be removed from the patient's face and discarded, following the removal of the surgical drapes. This avoids any risk of cross-contamination between procedures.

Thus it will be seen that a simple, cost-effective device has been described which can significantly improve the ease with which ophthalmic surgery can be carried out under topical anaesthetic. It will be appreciated, however, that the device described above is merely an example of the implementation of the invention and that it could take many different forms, particularly with regard to its shape and how it is located on the head of the patient.

Moreover, the present application has also described a novel surgical technique in which improved ophthalmic surgery can be conducted by fixating the patient's contra-lateral eye during surgery. It will be appreciated that this could be achieved in other ways than use of the device described above, albeit that the device is particularly convenient and affective for this.

Claims

Claims 1. A surgical assistance device comprising a frame carrying a light source, the frame being adapted to be attached to a human or animal patient's head such that light from the light source is directed in use towards an eye of said patient.
2. A device as claimed in claim 1 wherein the frame is adapted to be attached to the patient's face.
3. A device as claimed in claim 1 or 3 wherein the frame comprises an adhesive portion which is suitable for attachment to the patient's skin.
4. A device as claimed in any preceding claim wherein the frame comprises a tripod arrangement.
5. A device as claimed in any preceding claim wherein the light source is arranged so that in use it is provided directly in front of the patient's eye.
6. A device as claimed in any preceding claim wherein the light source is a substantially point light source.
7. A device as claimed in any preceding claim wherein the light source is provided behind an aperture or recessed into a bore.
8. A device as claimed in any preceding claim wherein the light source comprises an LED.
9. A device as claimed in any preceding claim adapted to be disposed after a single use.
10. A device as claimed in any preceding claim comprising a pair of contacts in an electrical path between a battery and the light source, said contacts being separated by a non-conductive tab.
11. A method of surgery performed on a human or animal subject comprising directing a light source at a first, open eye of the subject and operating on a second eye of said subject.
12. A method as claimed in claim ii wherein a device as claimed in any of claims ito lOis used to provide the light source.