WO2004010876A1

WO2004010876A1 - Pupil dilating device and apparatus for use therewith

Info

Publication number: WO2004010876A1
Application number: PCT/CA2002/000991
Authority: WO
Inventors: Daniel Guerin
Original assignee: 3062696 Nova Scotia Limited
Priority date: 2002-06-28
Filing date: 2002-06-28
Publication date: 2004-02-05
Also published as: AU2002317086A1

Abstract

A device for insertion through a single incision in an eye is used to mechanically dilate the pupil in a substantially circular fashion in order to facilitate certain eye surgeries. An apparatus is also provided to house, insert, manipulate and remove the device from the eye. Methods of using the device and the apparatus are also provided.

Description

PUPIL DILATING DEVICE AND APPARATUS FOR USE THEREWITH

BACKGROUND OF THE INVENTION

The present invention relates to a means of mechanically dilating the pupil of an eye and more specifically to a partial ring-shaped flexible device adapted to be inserted through a single incision in the eye. The device serves to mechanically dilate a pupil in a substantially circular fashion in order to facilitate certain eye surgeries including cataract surgeries and surgeries necessitating a vision of the ocular elements situated behind the iris. An apparatus adapted for use with the dilating device is also provided to house, insert, position and remove the device from the eye.

Devices have been proposed in the art which are purposed to mechanically dilate a pupil of an eye. One such device is described in United States Patent No. 5,374,272 (Arpa et al.) entitled "Apparatus and method for mechanically dilating the pupil of an eye". Arpa et al. teach an elastomeric ring used to mechanically dilate and protect a pupil during eye surgery. The ring is inserted, positioned and removed using forceps or a similar instrument. The ring is inserted in a compressed state through a single incision in the cornea or sclera and is then allowed to expand, thereby applying an outward force to the pupillary rim of the iris thus dilating the pupil. In cross-section, the ring is C-shaped and an inferior portion of the ring has a larger diameter than a superior portion. This device is not adapted to be stored, inserted, positioned or removed by an apparatus for use with a dilating device and it comprises a complete ring shape and does not exist in elongated form.

Another such device for mechanically dilating a pupil is disclosed in United States Patent No. 5,267,553 (Graether) entitled "Pupil Expander and Method of Using the Same". Graether describes a partial ring, C-shaped in cross-section, used to mechanically dilate a pupil. The ends of the ring are connected by a strap. The device is inserted in an elongated form using forceps through an incision in the eye. The forceps are gradually removed causing the elongated ring to become circujar thereby pushing against the pupillary rim and thus dilating the pupil. The device is removed by cutting the strap connecting the ends of the ring and pulling the device out through the incision. A second incision is made in order to insert a lens manipulator tool which is used to hold the device in place while the forceps are withdrawn. The necessity for the second incision and the strap which must be cut for removal represent shortcomings of this prior device.

In United States Patent No. 5,427,088 (Graether) (continuation in part of U.S. Patent 5,267,553 above) entitled "Apparatus for Inserting a Pupil Expander", Graether teaches a device for inserting a pupil expander, as described in his previous patent (U.S. Patent No. 5,267,553), into position. This device is designed only to insert and position the pupil expander and is not used in the removal process. Structurally, the device has two leg portions which fit inside the pupil expander and the device is controlled by sliding a button on the handle of the insertion device.

The expressions "mechanically dilate", "dilate", "dilating" and variations thereof as used in the description and claims with reference to the present invention are defined herein to include each of the following: to mechanically dilate causing a pupil to be changed from a less dilated state to a more dilated state, to maintain an approximately constant degree of dilation of a pupil, and to impede dilation from decreasing below a set value. The implication being made hereby, when taken with the specification in its entirety, is that the device of the present invention is capable of not only increase the dilation of a pupil, but also maintaining the dilation of a pupil once the increased dilation has been achieved or if, the degree of dilation is sufficient at the time of insertion of the device but may otherwise decrease to an insufficient degree if the device were not inserted.

SUMMARY AND DESCRIPTION OF THE EMBODIMENTS OF THE INVENTION

Dilation of a pupil is often desired in a surgical context such as cataract or retina operations or other operations necessitating a vision of ocular elements situated behind the iris in order to facilitate and/or permit surgery to be performed.

The present invention provides a device to mechanically dilate a pupil of an eye in a substantially circular fashion, which is adapted for use by way a single opening such as an incision in the cornea. A suitable incision is often required for many operations of the type requiring pupil dilation. The present invention also provides a means for facilitating housing, inserting, positioning and removing the device. The device is so structured to exist in at least a linear form and an incomplete-annular (preferably incomplete-circular) form and all forms therebetween. The device also provides a means to effectively contact a pupillary rim such that an outward force may applied to the pupillary rim thus enabling dilation of the pupil.

The above device may be structurally provided by a flexible device with one or more apertures, preferably two, such that the device is adapted to removably cooperate with an apparatus for housing, inserting, positioning and removing the device.

The present invention also provides a means for housing under sterile conditions, inserting, positioning and removing a pupil dilating device including a means for housing the device in a linear position, means to permit the device to be extracted from the apparatus and means to remove the device from a position against the pupillary rim and a means to cooperate with the device such that the device may be displaced.

The apparatus advantageously comprises an inner tube adapted to receive the device, an outer tube adapted to receive the inner tube and containing a spring, a member such as a right angle hook adapted to fit inside each of the tubes and adapted to engage the device, a control part adapted to fit inside the outer portion and adapted to move the member such that the device, when cooperating with the member, may be manipulated in a desired manner.

The dilating device, when being stored in the apparatus for use with a dilating device, is ready for use.

DEVICE

A flexible device for dilating a pupil of an eye comprising a dilating member capable of assuming an incomplete-annular configuration, the dilating member being adapted for insertion in an eye to cooperate with an inner side of a pupillary rim of an iris of the eye, such that, when the device is in position in contact with the pupillary rim, a degree of dilation of the pupil of the eye may be increased, maintained, or impeded from decreasing below a set value.

For the purpose of clarity the inner side of a pupillary rim is defined herein as the side of the pupillary rim adjacent to the pupil and opposite the side of the pupillary rim adjacent to the iris. Also, for the purpose of clarity, the term incomplete-annular form is defined herein as an annulus having an arc of less than 360 degrees.

Preferably, the dilating member, when in incomplete-annular configuration, comprises an incomplete-annular concave portion adapted to contact the pupillary rim, a first annular lip adjacent to the concave portion adapted to contact an upper portion of the pupillary rim and a second annular lip, adjacent to the concave portion and opposite the first lip and adapted to contact a lower portion of the pupillary rim. The lips may have equal or unequal diameters depending on the circumstances including the anatomy of the eye under treatment.

Preferably, the device comprises an engagement means near one or both ends of the dilating member for facilitating manipulation including insertion of the device into, and removal of the device from, cooperation with the pupillary rim. The aperture(s) is/are preferably in the concave portion and preferably near an/the end(s) of the dilating member.

The device is preferably adapted to enable substantially circular dilation of the pupil and, to this end, the device is preferably capable of assuming an incomplete-annular form and more preferably in an incomplete-circular form wherein the angle of opening is between 30 and 90 degrees, preferably between 50 and 70 degrees and most preferably approximately 60 degrees.

The device is preferably adapted to be inserted, manipulated and removed through an opening in the cornea of the eye and preferably wherein the opening is the sole opening required for inserting, manipulating and removing the device. Forceps or another suitable instrument may additionally be used to manipulate the device, if desired, in order to aid in positioning or otherwise manipulating the device, although, the use of such another suitable instrument is not necessary. The device is adapted to be used in eye surgeries including cataract surgery and surgeries necessitating a vision of the ocular elements situated behind the iris.

In another embodiment, the device is formed with a complete-annular configuration including when the device is in cooperation with the pupillary rim of the eye. METHOD OF INSERTING THE DEVICE

According to another aspect of the present invention there is provided a method of use of a device for dilating a pupil of an eye as described above, comprising the steps of inserting the device into the eye by passing the device through an opening in a cornea of the eye; and causing the device to assume an incomplete-annular form and positioning the device to cooperate with a pupillary rim such that a degree of dilation of the pupil of the eye is increased, maintained, or impeded from decreasing below a set value.

The method may additionally include the steps of contacting an end of the device to the pupillary rim; and thereafter causing the device to follow a contour of the pupillary rim i thereby increasing an area of contact between the device and the pupillary rim until the device exists in an incomplete-annular form. The method may also include the step of transforming the device from an incomplete-annular form to a complete-annular form.

The method may also be such that the device exists in the substantially linear form during the above passing step and wherein the above causing step further includes transforming the device from the linear form to the incomplete-annular form. The method may also include a step, prior to the passing step, of selecting a suitably configured and sized device for use in the method herein based on the anatomy of the eye under treatment in order to achieve a desired dilation of a pupil. An instrument such as forceps may also be used to aid in achieving the cooperation of the device with the pupillary rim.

I METHOD OF REMOVING DEVICE

The method of use of the device described above may also include the following removal steps: engaging the device, when in contact with the pupillary rim, with a removal means; and removing the device from the eye using the removing means.

The removal means may be preferably cooperated with the aperture(s) of the device. A ! gripping means such as, for example, forceps or another suitable instrument may alternatively be used to remove the device.

APPARATUS FOR USE WITH THE DEVICE

According to still another aspect of the present invention there is provided an apparatus for ) use with a device as described above comprising a housing means adapted to house the device under sterile conditions; an engaging member in cooperation with the housing means and capable of engaging, at an engaging end thereof, the device to enable displacement of the device thereby enabling manipulation of the device including enabling insertion of the device into an eye and enabling removal of the device from the eye. The member may comprise a hook element for engagement with an aperture of the device.

The apparatus described above may be such that the housing means comprises an outer tube having a first and a second aperture at opposite ends thereof, wherein the first aperture is adapted to receive the device; an inner tube movable within the outer tube and movable through the first aperture of the outer tube; a control part movable within the outer tube and movable through the second aperture; and a spring within the outer tube, wherein a first end of the control part, residing outside of the outer tube, is adapted to be manipulated by a hand or the like; a connecting end of the engaging member opposite the engaging end is adapted to cooperate with a second end of the control part, opposite the first end, whereby displacement of the member may be enabled by displacement of the control part; the spring is adapted to cooperate with the second end of the control part; the engaging member is movable within the inner tube; the apparatus is adapted to exist in a housing form wherein the engaging member is cooperating with the device, the device is inside the inner tube, and the inner tube is inside the outer tube.

The aperture(s) of the device may be used to engage the member with the device. The > housing means may be adapted to house the device when the device exists in the linear form.

METHOD OF INSERTING THE DEVICE USING THE APPARATUS

According to still yet another aspect of the present invention there is provided a method of use of an apparatus as described above comprising the steps of (a) displacing the device i out of the apparatus and through an opening in a cornea of an eye; and (b) positioning the device into cooperation with the pupillary rim of the eye.

The method may also included, subsequent to step (b), the step of disengaging the engaging member from the device and/or prior to step (a), the steps of: engaging, when the device is outside of the apparatus, the member with the device; displacing the device into ) the apparatus. During steps (a) and (b) the device may be transformed from a linear form to an incomplete-annular form or complete-annular form.

The method may also comprise a step, prior to step a), of selecting a suitably configured and sized device for use in the method herein based on the anatomy of the eye under treatment in order to obtain a desired dilation of the pupil.

Another method of use of an apparatus as described above may comprise the steps of i) positioning the apparatus in a position adapted for insertion of the inner tube, having the device therein, through an opening in a cornea of an eye and ii) displacing the control part in the forward direction relative to the outer tube thereby: compressing the spring, displacing the inner tube, having the device therein, in the forward direction relative to the outer tube i thereby causing the inner portion to pass through the opening in a cornea of an eye and manipulating the device into the cooperation against the pupillary rim of the eye. The method may be such that during step ii) the device is transformed from a linear form to a incomplete-annular form. The method may also comprise, prior to step i), the steps of cooperating the structure with the device; causing the spring to decompress thereby: i displacing the device into the inner tube, displacing the inner tube into the outer tube. The method may also comprise, after step ii), a step of removing the structure from cooperation with the device. The method may also comprise a step, prior to step i), of selecting a suitably configured and sized device for use in the method herein based on the anatomy of the eye under treatment in order to obtain a desired dilation of the pupil.

) METHOD OF REMOVING THE DEVICE USING THE APPARATUS

According to another aspect of the present invention there is provided a method of use as described above further comprising the steps of: engaging the engaging member with the device when the device is in an eye, wherein in an eye includes in cooperation with the pupillary rim; and removing the device through the opening of the cornea. ϊ

The method may comprise the steps of cooperating the structure with the device when the device in an eye, wherein in an eye includes in cooperation with the pupillary rim; and causing the spring to decompress thereby: displacing the device into the inner tube, displacing the inner tube into the outer tube and thereby passing the inner tube through the

) incision in the cornea of the eye. BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of a dilating device having a portion of an apparatus for use with a dilating device cooperating therewith;

Figure 2 is a perspective view of a dilating device of Figure 1 and an apparatus for use with ϊ a dilating device in extended form;

Figure 3 is a perspective view of a dilating device of Figure 1 and an apparatus for use with a dilating device in extended form wherein the interior components of the apparatus are illustrated;

Figure 4 is a perspective view of a dilating device of Figure 1 and an apparatus for use with ) a dilating device in partially extended form;

Figure 5 illustrates a dilating device of Figure 1 in cooperation with an apparatus for use with the dilating device wherein the device is in contact with a pupillary rim of an eye;

Figure 6a illustrates a dilating device of Figure 1 in cooperation with an apparatus for use with the dilating device wherein the device is in increased contact with the pupillary rim to i that in Figure 5;

Figure 6b illustrates a dilating device of Figure 1 in cooperation with an apparatus for use with the dilating device wherein the device is in increased contact with the pupillary rim to that in Figure 5 wherein a manipulating instrument is in contact with the device;

Figure 7 illustrates a dilating device of Figure 1 in increased contact with the pupillary rim to ) that of Figures 6a and 6b;

Figure 8a illustrates a dilating device of Figure 1 in position in the eye cooperating with an apparatus for use with a dilating device;

Figure 8b illustrates a dilating device of Figure 1 in position in the eye cooperating with forceps; and Figure 9 illustrates a cross section view of dilating device of Figure 1 in position in the eye.

DETAILED DESCRIPTION OF THE EMBODIMENTS OF THE INVENTION

A dilating device 1 according to an embodiment of the present invention is illustrated in Figure 1 and has a hook portion 5 with hook end 5a at right angles thereto of an apparatus for use in cooperation with the device 1. The dilating device 1 is illustrated in a partially circular or angular form with a U-shaped cross section. The device 1 may be described as having a first lip 3a, a second lip 3b and a concave portion 2 therebetween. Two apertures 4 are provided in the device, on the concave portion 2 and near the ends of the device for receiving a hook end 5a, when required. The device is adapted to be positioned on the surface of a pupil in contact with the pupillary rim and specifically positioned such that the first lip 3a and the second lip 3b are above and below the pupillary rim, respectively, and such that the pupillary rim is seated against the interior portion 4 as seen in Figure 9. The device 1 is symmetrical about the circular plane thereby enabling the devicel to be used such that the first and second lips are interchangeable.

The dimensions of the dilating device are preferably approximately as follows: an inner diameter of 7 to 9mm, an outer diameter (including the lips) of 9 to 11 mm, a height of about 1.3mm and an internal height, which excludes the two lips 3a and 3b, of about 1.0mm, the concave portion being inset by about 1.3mm from the outer edge. In order to select the size of the dilating device 1 to be used, the anatomy of the eye under treatment should be i taken into consideration in order to result in the obtaining of an appropriate degree of dilation. Of particular importance are the inner and outer diameters of the dilating device since the pupil and iris dimensions may vary among patients and between left and right eyes of a single patient. The dilation device 1 is adapted to exist, notably when in position against a pupillary rim, in an incomplete-annular form, preferably an incomplete-circular form with an opening angle of from about 30° to 90°, preferably 50° to 70°, and most preferably approximately 60°, that is, defining an arc of approximately 300°.

An apparatusl 1 is illustrated in Figure 2 in cooperation with the device 1 and in particular where the hook portion 5 is inserted through one of the apertures 4 of the device 1. The apparatus 11 is shown in elongated form, that is, in the form characterized in that the device i 1 is in substantially partially annular form and located outside of an inner tube 6. The inner tube 6 below is adapted to house the device 1 and is, in turn, adapted to be housed by outer tube 7.

The cooperation among the components of the apparatus 11 is illustrated in detail in Figure 3. In Figure 3, the device 1 removably cooperates with hook portion 5, hook portion 5 passes through inner tube 6 and cooperates with control part 9 which is partially inside outer tube 7 and projects therefrom. Control part 9 has a handle portion 10 which facilitates manipulation of the control part 9 and, in turn, the hook portion 5. A spring 12 shown in compressed form is contained within outer tube portion 7. The apparatus 11 has a rectangular end 8 at the end of the outer tube 7 which serves to aid in the manipulation of ' the apparatus 11. The operation of the apparatus 11 will be described below with reference to Figure 5 to 8b.

Figure 4 illustrates an apparatus 11 and device of Figure 2 wherein the apparatus 11 is shown in partially extended form wherein the device 1 is inside the inner tube 6.

The dimensions of the apparatus 11 for use with a dilating device 1 are preferably approximately as follows: a length of control part 9 of 50.8 mm, an allowable spring length of 37.5 mm , a combined outer tube 6 and inner tube 7 length, when the device 1 is fully extended, of 75mm.

Having more than one aperture 4 provided on the device 1 allows a user to use the particular aperture which is most convenient.

i The device is preferably made of a non-toxic plastic material, which does not cause irritation to ocular tissue, such as silicone or hydroxyethyl methacrylate (hema) and is adapted to be so structured to achieve the shape modification described herein. The physical properties of the device are such that the device when position in contact with the pupillary rim provides mechanical dilation as described herein.

i Figures 5, 6a/6b and 7 illustrate certain progressive stages of insertion of the device 1 into position in contact with the pupillary rim 14a of the iris 14 surrounding the pupil 13. Explanation of these stages will be complemented by reference to Figures 1 to 4 in order to explain the control of the apparatus 11. In Figure 5, the inner tube 6 of the apparatus 11 of the device 1 is shown passing through a corneal incision 15 and the device 1 is in contact with the pupillary rim 14a. In order to arrive at this stage, the apparatus 11 is positioned for insertion through the corneal incision 15. In particular, the apparatus 11 is in housing form. The inner tube 6 is then passed though the corneal incision 15 by control of the control part » 9, preferably pushing in the forward direction thereby causing compression of the spring 12.

The apparatus 11 is then positioned such that the device 1 , cooperating with the hook portion 5, is slightly out of the inner tube 1 , and the device 1 is contacted to the pupillary rim 14a. At this time, the device 1 is made to follow the contour of the pupillary rim 14a by control of the apparatus 11 and preferably by pushing on the control part 9.

) In Figures 6a, the device is somewhere in between the linear and substantially incomplete- annular forms. The degree of dilation has been increased from that in Figure 5. Figure 6b illustrates an alternative method for inserting the devicel using a manipulation device 17 passed through a second corneal incision 16 to aid in the manipulation of the device 1. Once the device 1 has reached the incomplete-annular form as seen in Figure 7, wherein

5 the degree of dilation is greater than that of Figures 6a and 6b or at a time determined by a user such as once a sufficient degree of dilation has been obtained, the apparatus 11 is detached from the device 1 and removed through the corneal opening 15.

The device 1 may be removed using the apparatus 11 or by forceps 18 or another suitable ) instrument. In order to remove the device 1 using the apparatus 11 , the apparatus 11 , in elongated form, is cooperated with the device 1 in substantially partially annular form, in particular the hook portion 5a is cooperated with an aperture 4. The device 1 is then removed along with the apparatus 11 through the corneal opening 15 by control of the apparatus, preferably by releasing the forward force on the control part 9 and allowing the 5 spring 12 to elongate. Alternatively, in order to remove the device 1 using forceps 18, the forceps 18 are cooperated with the device 1 in incomplete-annular form and the device 1 is then removed along with the forceps 18 through the corneal opening 15.

INDUSTRIAL APPLICABILITY

The pupil dilating device, apparatus for use therewith and methods of using the device and ) apparatus as taught herein generally provide improved means of mechanically dilating a pupil of an eye in order to facilitate certain eye surgeries.

Claims

CLAIMS:

1. A flexible device for dilating a pupil of an eye comprising a dilating member (1 ) capable of assuming an incomplete-annular configuration, the dilating member (1) being adapted for insertion in an eye to cooperate with an inner side of a pupillary rim (14a) of an iris (14) of the eye, such that, when said device is in position in contact with the pupillary rim (14a), a degree of dilation of the pupil (13) of the eye may be increased, maintained, or impeded from decreasing below a set value.

2. A device according to claim 1 characterized in that the dilating member (1), when in incomplete-annular configuration, comprises an incomplete-annular concave portion (2) adapted to contact the pupillary rim (14a), a first annular lip (3a) adjacent to said concave portion (2) adapted to contact an upper portion of the pupillary rim (14a) and a second annular lip (3b), adjacent to said concave portion (2) and on an opposite side of said first lip (3a) and adapted to contact a lower portion of the pupillary rim (14a).

3. A device according to claim 2 characterized in that said first and second annular lips (3a, 3b) have equal diameters.

4. A device according to claim 2 characterized in that said first and second annular lips (3a, 3b) have unequal diameters.

5. A device according to claim 1 characterized in that said device comprises an engagement means near one or both ends of the dilating member (1) for facilitating manipulation including insertion of said device into, and removal of said device from, cooperation with the pupillary rim (14a).

6. A device according to claim 5 characterized in that said engagement means comprises one or two apertures (4).

7. A device according to claim 6 characterized in that said engagement means comprises two apertures (4) located one at each end of said dilating member (1). comprises two apertures (4) located one at each end of said dilating member (1).

8. A device according to claim 1 characterized in that said dilating member (1) is of incomplete-circular configuration.

9. A device according to claim 1 characterized in that said dilating member (1) is capable of assuming an incomplete-annular configuration with an opening angle of between 30 and 90 degrees.

10. A device according to claim 9 characterized in that said dilating member (1) is capable of assuming an incomplete-annular configuration with an opening angle of between 50 and 70 degrees.

11. A device according to claim 1 characterized in that said dilating member (1 ) is further capable of assuming a complete annular configuration for cooperation with the inner side of the pupillary rim (14a).

12. A method of use of a device according to any one of claims 1 to 11 for dilating a pupil (13) of an eye, comprising the steps of: inserting the device into the eye by passing the device through an opening (15) in a cornea (19) of the eye; and causing the device to assume an incomplete-annular form and positioning the device to cooperate with a pupillary rim (14a) such that a degree of dilation of the pupil (13) of the eye is increased, maintained, or impeded from decreasing below a set value.

13. A method according to claim 12 characterized in that the causing step further includes the steps of: contacting an end of the device to the pupillary rim (14a); and thereafter causing the device to follow a contour of the pupillary rim (14a) thereby increasing an area of contact between the device and the pupillary rim (14a) until the device exists in an incomplete-annular form.

14. A method according to claim 12 further comprising the steps of: engaging the device, when in contact with the pupillary rim (14a), with a removal means; and removing the device from the eye using the removing means.

15. An apparatus for use with a device according to any one of claims 1 to 11 comprising: housing means (6, 7) adapted to house said device under sterile conditions; an engaging member (5) in cooperation with the housing means (6, 7) and capable of effecting displacement of said device from said housing means (6, 7) thereby enabling manipulation of said device including insertion of said device into an eye and removal of said device from the eye.

16. An apparatus according to claim 15 characterized in that said engaging member (5) comprises a hook element (5a) for engagement with an aperture (4) of the device.

17. An apparatus according to claim 15 characterized in that said housing means (6, 7) comprises: an outer tube (7) having a first and a second aperture at opposite ends thereof, wherein said first aperture is adapted to receive said device; an inner tube (6) movable within said outer tube (7) and movable through said first aperture of said outer tube (7); a control part (9) movable within said outer tube and movable through said second aperture; and a spring (12) within said outer tube (7), wherein a first end (10) of said control part (9), residing outside of said outer tube (7), is adapted to be manipulated by a hand; a connecting end of said engaging member (5) opposite an engaging end thereof is adapted to cooperate with a second end of said control part (9), opposite said first end, whereby displacement of said engaging member (5) may be enabled by displacement of said control part (9); said spring (12) is adapted to cooperate with said second end of said control part (9); said engaging member (5) is movable within said inner tube (6); said apparatus is adapted to exist in a housing form wherein said engaging member (5) is cooperating with said device, said device is inside said inner tube (6), and said inner tube (6) is inside said outer tube (7).

18. A method of use of an apparatus according to claim 15 comprising the steps of: a) displacing the device out of the apparatus and through an opening in a cornea(15) of an eye; and b) positioning the device into cooperation with the pupillary rim (14a) of the eye.

19. A method according to claim 18 further comprising, subsequent to step b) the step of disengaging the engaging member (5) from the device.

20. A method according to claim 18 further comprising, prior to step a), the steps of: engaging, when the device is outside of the apparatus, the engaging member (5) with the device; and displacing the device into the apparatus.

21. A method according to claim 18 characterized in that the device is transformed from a linear form to an incomplete-annular form during steps a) and b).

22. A method according to claim 18 further comprising the steps of: engaging the engaging member (5) with the device when the device is in an eye, wherein in an eye includes in cooperation with the pupillary rim (14a); removing the device through the opening of the cornea (19).

23. A method according to claim 13 further comprising, after the causing step, the step of causing the device to be transformed from said incomplete-annular form to a complete- annular form.

24. A method according to claim 21 further comprising, after step b), the step of causing the device to be transformed from said incomplete-annular form to a complete-annular form.