Device for pupil expansion

The present description is directed to devices, systems and methods for use in an ophthalmic procedure and, more particularly, to devices, systems, and methods for pupillary expansion as a part of an ophthalmic surgery.

BACKGROUND

Several ophthalmic surgeries and procedures require dilation of the pupil to allow adequate visualization of the inside of the eye and, in particular, the portions of the posterior chamber and the posterior segment of the eye. For example, proper dilation of the eye is generally essential during cataract and posterior segment surgery. Pupil dilation may also be necessary to remove foreign bodies lodged behind the iris.

In some cases, a patient's pupil can resist dilation efforts. For example, previous surgery, recent trauma, and exfoliation syndrome can prevent the pupil from dilating properly.

Various approaches have been adopted to obtain and / or improve pupil dilation. Some approaches are primarily pharmacological, while other approaches involve surgery (i.e. eye incisions) or mechanical manipulation of the iris. Pharmaceutical approaches are generally less preferred because, in a significant number of patients, pharmaceutical products do not effectively dilate the pupil. Surgical approaches, including sphincterotomies and iridectomies in the sector, also generally find opposition due to the possibility of surgical complications and cosmetic consequences. Another surgical approach uses sutures to fix the retracted iris through the scleral wall, but this approach requires surgery.

<img file="AR090584A1_D0001.tif" />

delicate and time consuming. A hybrid surgical-mechanical approach involves the use of infraocular tacks that fix the iris to the sclera in a retracted position, but this approach requires the insertion of a surgical instrument behind the iris without proper visualization, and can lead to inadvertent puncture of the Iris already pigment release in the eye. A mechanical approach to dilate or expand the pupil includes retracting the iris with translimbal iris hooks, which can cause damage to the iris tissue. Also, both infraocular tacks and iris hooks occasionally move or slide from one place, which can cause significant complications during surgery or another ophthalmic procedure.

The devices, systems and methods disclosed herein resolve one or more of the deficiencies of the prior art.

SYNTHESIS

The disclosure generally refers to, and encompasses, devices, systems, and methods for use in ophthalmic surgery and, more specifically, to ophthalmic devices, systems, and methods to retract the iris to expand the pupil and keep the pupil in a state. expanded during ophthalmic surgery or other procedure, thus facilitating the diagnosis and / or treatment of various eye conditions.

In an exemplary embodiment, the present disclosure describes a pupil expander comprising a support element and a plurality of coupling portions. The support element is sized to expand a pupil. The coupling portions are coupled to, and separated around the support element. Each of the coupling portions has a shaped and dlmensloned recess to receive an internal margin of an iris.

In some embodiments, the plurality of coupling portions extends radially from the support member.

In some embodiments, each of the coupling portions has a contact surface that has a curvature that substantially corresponds to the curvature of the inner margin of the iris.

In another exemplary embodiment, the present disclosure describes a pupil expander to dilate a pupil and keep the pupil in a dilated state during an ophthalmic procedure. The pupil expander comprises a support element and a plurality of coupling portions coupled to the support element. The support element is capable of self-expanding in a configuration by default and sized to dilate the pupil. Each of the coupling portions includes an anterior flange and a posterior flange that extend radially from the support member, and a contact surface that is formed between them that is configured to seat an inner margin of an iris.

In another exemplary embodiment, the present disclosure describes a method for stretching an iris to dilate a pupil of one eye. The method comprises forming an incision in the eye, inserting a pupil expander comprising coupling portions coupled to a support element that has an unexpanded state and an expanded state in the pupil through the incision, while the element support is in an unexpanded state, and expand the support element in the pupil until the coupling portions receive an inner margin of the iris and stretch the iris.

In another exemplary embodiment, the present disclosure describes a method of locating a pupil expander with respect to an eye. The method comprises inserting the pupil expander in an unexpanded state into a lumen of the administration / extraction apparatus sized to receive the pupil expander, wherein the administration / extraction apparatus comprises a plunger located longitudinally within a tubular housing and a drive mechanism configured to cause longitudinal translation of the plunger along a longitudinal axis of the housing. The method also comprises activating the drive mechanism to move the plunger along the longitudinal axis of the housing toward a distal end of the administration / extraction apparatus to move the pupil expander from the lumen of the administration / extraction apparatus in the eye.

It should be noted that both the above general description and the following detailed description are exemplary and explanatory and are intended to provide an explanation of the present disclosure without limiting the scope thereof. In this regard, the aspects, characteristics and advantages of the present disclosure will be apparent to a person with experience in the art from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate embodiments of the devices and methods disclosed herein and, together with the description, serve to explain the principles of the present disclosure.

Fig. 1 illustrates a top plan view of an exemplary pupil expander in accordance with an embodiment of the present disclosure.

Fig. 2 illustrates a perspective view of a portion of the pupil expander illustrated in Fig. 1, illustrating an iris cup in accordance with an embodiment of the present disclosure.

Fig. 3 illustrates a side view of the iris cup illustrated in Fig. 2.

Fig. 4 illustrates a cross-sectional side view of the pupil expander illustrated in Fig. 1.

€

Fig. 5 illustrates a cross-sectional side view of a pupil expander according to another exemplary embodiment of the present disclosure.

Fig. 6 illustrates a cross-sectional side view of an iris cup according to another exemplary embodiment of the present disclosure.

Fig. 7 illustrates a side view of an iris cup according to another exemplary embodiment of the present disclosure.

Fig. 8 illustrates a side view of an iris cup according to another exemplary embodiment of the present disclosure.

Figs. 9a and 9b illustrate top plan views of the pupil expander illustrated in Fig. 1 inserted into an eye according to an exemplary embodiment of the present disclosure.

Fig. 10 illustrates a top plan view of the pupil expander illustrated in Fig. 1, located within an eye according to an embodiment of the present disclosure.

Fig. 11 illustrates a cross-sectional side view of the pupil expander illustrated in Fig. 1, located within an eye according to an embodiment of the present disclosure.

Fig. 12 illustrates a schematic view of an exemplary pupil expander delivery instrument that includes an exemplary plunger tip in accordance with an embodiment of the present disclosure.

Fig. 13a illustrates a schematic view of the exemplary plunger tip illustrated in Fig. 12.

Fig. 13b illustrates a perspective view of an exemplary connector according to an embodiment of the present disclosure.

Fig. 14 illustrates a perspective view of an exemplary pupil expander injection apparatus according to an embodiment of the present disclosure.

Fig. 15 illustrates an enlarged perspective view of a distal portion 5 of the exemplary pupil expander injection apparatus illustrated in Fig. 14.

Fig. 16 illustrates a partially cropped perspective view of an exemplary drive mechanism of the exemplary pupil expander injection apparatus illustrated in Fig. 14.

DETAILED DESCRIPTION

In order to promote the understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and a specific vocabulary will be used to describe them. However, it will be understood that no limitation of the scope of the disclosure is anticipated. Any alteration and further modification of the devices, instruments and methods described, and any other application of the principles of the present disclosure are fully contemplated as would normally be understood by one skilled in the art to which the disclosure refers. In particular, it is fully contemplated that the features, components and / or steps described with respect to one embodiment may be combined with the features, components and / or steps described with respect to other embodiments of the present disclosure. For simplicity, in some cases the same reference numbers are used in all drawings to refer to equal or similar parts.

The present disclosure relates, in general, to ophthalmic pupil expanders and associated systems and methods of administration and used in ophthalmic surgeries and procedures that require adequate visualization of the inside of the eye, such as, by way of non-exclusive example, surgeries of cataracts,

Ί c

vitreoretinal surgeries, and other surgeries of the posterior segment. In some cases, the embodiments of the present disclosure may be configured to be part of an ophthalmic surgical system.

The present disclosure provides a pupil expander that uses a shape memory ring with iris cups to dilate a pupil and keep the pupil in a dilated state while maintaining the stability of the chamber during an ophthalmic surgery or procedure. The pupil expander can assume an unexpanded state to facilitate its nontraumatic insertion and removal of an eye through a primary incision, and can assume a predetermined expanded state within the eye. In its expanded state, the pupil expander comprises a substantially circular ring with substantially flexible iris coupling portions referred to herein as iris cups that hold the pupil expander against an iris, allowing the expander Pupil self-stabilize and self-retain in the eye during the entire surgery (that is, without the use of sutures, tacks, or a manually held instrument). Therefore, the pupil expander disclosed herein improves pupil dilation and maintenance of pupil dilation throughout surgery or other ophthalmic procedure, thus facilitating the diagnosis and / or treatment of various eye conditions The present disclosure also provides an insertion device that can be used to insert and remove the pupil expander.

Fig. 1 illustrates a pupil expander 100 in an expanded state in accordance with an embodiment of the present disclosure. While the pupil expander 100 illustrated in Fig. 1 is configured for use in ophthalmic surgeries, such as vitreoretinal surgery, the pupil expander can be used in any ophthalmic context, including diagnosis, treatment, ex-evaluation. alive, and the post mortem evaluation. The pupil expander 100, which is capable of self-retention in a patient's eye during an entire surgical procedure, can improve visualization and access to structures inside an eye, such as within the posterior segment during a procedure. vitreoretinal Some embodiments of the pupil expander 100 may be configured as a disposable single-use device, which allows the use of a new pupil expander for each patient.

The pupil expander 100 comprises a support element 110 has a central opening 115 and a plurality of iris cups 120, 125 located circumferentially on the support element 110. In the illustrated embodiment, the pupil expander 100 includes five cups of iris 120 and two glasses of iris 125 fixedly arranged in a symmetrical pattern in the support element 110. The iris cups 120, 125 are separated along the support element 110 to form a plurality of recesses 130 and a recess 140. The iris cups 120, 125 extend radially from the support member 110 such that if The pupil expander 100 is centrally located in an expanded state within the pupil of one eye, the cups of the iris would contact and extend the iris of the eye.

In other embodiments, the pupil expander may include any number and arrangement of iris cups that allow adequate pupil dilation and self-stabilization within the eye. The number and arrangement of iris cups 120, 125 can be selected considering, among other factors, the type of procedure to be performed, the surgeon's preferred surgical technique, or locations in which surgical instruments are usually placed ( for example, trocar cannulas) for ophthalmologic surgical procedures (for example, a surgical procedure that involves the posterior segment or the posterior chamber of the eye).

The support element 110 is shaped and configured to allow sufficient dilation of the pupil to allow visualization or access to the interior regions of the eye. The support element 110 is expanded from an unexpanded state to an expanded state that has a configuration by default. For example, in the embodiment illustrated in Fig. 1, the support element 110, in an expanded state, comprises a continuous, closed, annular ring with a predetermined circular shape that substantially corresponds to the shape of an average human pupil. In other embodiments, the support element comprises an open ring or a C-shaped ring. In other embodiments, the support element may have any of a variety of predetermined forms in the expanded state including, by way of non-exclusive example, an oval, a horseshoe, or an elliptical shape.

The support element 110 is constructed from a structurally deformable biocompatible material that can be elastically or plastically deformed without compromising its integrity. The support element 110 may be made of a self-expanding biocompatible material such as Nitinol or a flexible polymer, or a spring-loaded biocompatible elastically compressed spring material. Other materials having shape memory characteristics, such as alloys of particular metals, can also be used. Shape memory materials allow the support element to be restricted in a low profile configuration during administration in the eye and resume and maintain its expanded form in vivo after the administration process. The material composition of the support element 110 elastically predisposes the support element towards the expanded state. In particular, in the present example, the support element is formed from an elastic material that allows the support element to elastically deform into an unexpanded state to facilitate administration through a small incision (for example, a through a tubular administration instrument), and a spring into an expanded state when it enters the eye. In other embodiments, the support element may be made of a memory alloy so that it has a shape memory in the expanded configuration. The support element 110 may be coated with any of a variety of biocompatible materials including, by way of non-exclusive example, polytetrafluoroethylene (PTFE).

The support element 110 may be sized to have an external diameter D1 ranging from, for example, only about 6.0 to 8.0 mm in an expanded state to provide adequate viewing or access to the inside of the eye while remaining sufficiently Small enough to limit interference with other surgical instruments and / or a surgeon's hand during an ophthalmologic procedure. Other ranges of diameter are contemplated. In the embodiment illustrated in Figs. 1 and 2, the support element 110 has a substantially circular cross-section and a cross-sectional diameter D2 ranging from about 0.05 to 0.15 mm, although other sizes are contemplated. In other embodiments, the support element 110 may have any of a variety of transverse shapes including, without limitation, the rectangular, oval, square, rhomboidal, and half-moon shape.

As illustrated in Fig. 1, any of the recesses 130, 140 are shaped and defined by the support element 110 and a periphery 145 of the iris cups 120 and / or a periphery 150 of the iris cups 125. By For example, the recess 140 is shaped and defined by the support element 110, the periphery 145, and the periphery 150. In the illustrated embodiment, the iris cups 120, 125 are substantially equally spaced from each other, thereby forming recesses 130 of a substantially equal size. In other embodiments, the iris cups are unevenly separated from each other, thereby creating unevenly sized recesses. The recess 140 has a wider dimension than the recesses 130 to allow the passage of surgical instruments such as, by way of non-exclusive example, a phaco tip. The number and arrangement of the recesses 130, 140 corresponds to the number and arrangement of the iris cups 120, 125. For example, in the illustrated embodiment, the pupil expander 100 includes seven iris cups 120,125 in total and seven recesses 130, 140 in total. Alternative embodiments may include any number and arrangement of recesses 130, 140. Some embodiments may include an open support element that has a space or separation instead of the wide recess 140.

To simplify the description, only one of the iris cups (120) will be described in detail, and it would be understood that the iris cups 120, 125 are substantially identical, except for the differences described herein.

Fig. 2 illustrates a portion of the pupil expander 100, showing a portion of the support member 110 and an iris cup 120, which is again illustrated in Fig. 3. The iris cup 120 is shaped and configured to surround an inner margin of an iris when the pupil expander 100 is located in an average eye. In the illustrated embodiment, the iris cup 120 extends radially outwardly of the support member 110 to form the farthest periphery of the pupil expander 100.

As illustrated in Figs. 2 and 3, the iris cup 120 includes an anterior flange 160, a posterior flange 170, and a central portion 180. The central portion 180 forms the junction between the iris cup 120 and the support element 110. In the form of Illustrated embodiment of Fig. 3, the central portion 180 includes a hollow tube 200 that receives the support member therethrough. In some embodiments, the anterior flange and the posterior flange are configured to fit around the inner margin of the iris.

The anterior flange 160, the posterior flange 170, and the central portion 180 5 cooperate to form a contact surface 210, which is shaped and configured to contact and engage the Iris tissue in the Internal margin of the Iris and seat a portion of the Internal margin of the Iris. In the illustrated embodiment, the contact surface 210 is shaped as a receiving recess formed between the anterior and posterior flanges. The contact surface 210 has a width W that extends between the anterior flange 160 and the posterior flange 180. The width W forms the height of the recess. In one embodiment, the width W is within the range of approximately 0.30 to 0.70 mm, and preferably within the range of approximately 0.35 to 0.60 mm. The contact surface 210 has a longitudinal length L that extends the entire length of the iris cup. In one embodiment, the length L is within the range of about 0.50 to 1.5 mm, and preferably within the range of about 0.65 to 1.0 mm. This length allows the load on the Iris to be distributed in a greater percentage of the perimeter of the iris, reducing the trauma that can occur with point loads.

Additionally, by using multiple Iris cups that distribute the load, the Iris is further protected, which can increase the recovery rate and produce an improved surgical outcome.

In various embodiments, the contact surface 210 may have any of a variety of shapes designed to couple the Iris

Including, without limitation, a C shape, a more pronounced U shape, a rectangular shape, a V shape, and an elliptical shape. In some embodiments, the contact surface has a curvature that substantially corresponds to the curvature of the inner margin of the iris. In the illustrated embodiment, the contact surface 210 is substantially smooth. In other embodiments, the contact surface can be textured.

In some embodiments, the iris cups are part of the support element, for example, by injection molding. In other embodiments, the pupil expander comprises a multi-component device with the iris cups attached to the support element in the central portion by any of a variety of coupling mechanisms, including one or more of an adhesive, a threaded coupling, a snap fit coupling, a friction coupling, overmolding, heat shrinkage, heat welding, and / or any other mechanism to firmly connect the iris cups with the support element.

In some embodiments, the iris cups 120 are formed from a flexible material that allows some degree of deformation and flexibility.

In alternative embodiments, the iris cups are formed from a rigid or semi-rigid material. Iris cups 120 may be formed from any of a variety of biocompatible materials including, by way of example, not exclusive, silicone, silicone polyamide, polycarbonate, polymethylmethacrylate (PMMA), nylon, prolene, polyurethane, silica, polyamide or a combination thereof, or any other biocompatible material that has the required properties of resilience, flexibility, and suitability for use in ophthalmic procedures. The iris cups 120 may be coated with any of a variety of biocompatible materials including, by way of non-exclusive example, polytetrafluoroethylene (PTFE). In some embodiments, the individual components of the iris cup 120, including the anterior flange 160, the posterior flange 170, and the central portion 180, can be formed from different biocompatible materials of varying degrees of flexibility. For example, in some embodiments, the posterior flange may be formed from a more flexible and elastic material than the anterior flange to minimize damage or trauma from contact with a lens and an eye capsule.

Fig. 4 illustrates a cross-sectional side view along lines 4-4 of the pupil expander 100 illustrated in Fig. 1. In the illustrated embodiment, the iris cups 120 have a symmetrical cross-sectional profile, including the anterior flanges 160 and posterior 170 of substantially equal size and transversely. Also, each iris cup 120 is substantially identical. Therefore, the iris cups 120 of the pupil expander are shaped and configured to engage the anterior and posterior aspects of the iris in substantially the same measure and substantially the same way.

Although the iris cups 120 of the pupil expander 100 are substantially identical in size and transverse shape, other embodiments may include iris cups of different sizes and shapes.

For example, Fig. 5 illustrates a cross-sectional side view of a pupil expander 250 in accordance with another embodiment of the present disclosure. Pupil expander 250 includes iris cups of different cross profiles. In particular, the pupil expander 250 includes an iris cup

260 and an iris cup 270, which are substantially similar to the iris cups

120 except for the differences described herein. The iris cup 260 includes an anterior flange 275 and a posterior flange 280, and the iris cup 270 includes an anterior flange 285 and a posterior flange 290. As illustrated in Fig. 5, the iris cups 260, 270 have opposite transverse profiles, in which the front flange 285 of the iris cup 270 and the rear flange 280 of the iris cup 260 are longer than the rear flange 290 of the cup of iris 270 and anterior flange 275 of iris cup 260, respectively. Also, the distal ends 295, 296 of the anterior flange 285 of the iris cup 270 and the posterior flange 280 of the iris cup 260, respectively, can be tapered. Therefore, the different iris cups 260, 270 of the pupil expander 250 are shaped and configured to couple the anterior and posterior aspects of the iris in different sizes and in different ways. This combination of various flanges may tend to center and stabilize the pupil expander within the eye.

Figs. 6-8 illustrate several examples of iris cups that have different shapes and configurations. For example, Fig. 6 illustrates an iris cup 300 according to another embodiment of the present disclosure. The iris cup 300 is similar to the iris cup 120 except for the differences that can be observed by comparison of Figs. 6 and 3 or indicated herein. The iris cup 300 includes terminal portions 310 configured to grip and / or apply a compression force to the iris tissue. Additionally, the iris cup 300 includes a contact portion 320 partly formed by the terminal portions 310 in a partially closed D-shape.

Fig. 7 illustrates a side view of an iris cup 340 according to another embodiment of the present disclosure. The iris cup 340 is similar to the iris cup 120 except for the differences that can be observed by comparison of Figs. 7 and 3 or which are indicated herein. The iris cup 340 includes terminal portions 350 configured to grip and / or apply a compression force to the iris tissue. Additionally, the iris cup 340 includes elongated and extended flanges 370 cooperating with the terminal portions 350 to form a contact portion in an elongated, partially closed D-shape. The iris cup 340 also includes a central portion 380 that is enlarged, providing the iris cup 340 with a greater cross-sectional profile than, for example, the iris cup 120.

Fig. 8 illustrates a side view of an Iris 400 cup according to Even another embodiment of the present disclosure. The iris cup 400 is similar to iris cup 120 except for the differences that can be observed by comparison of Figs. 8 and 3 or indicated herein. Similar to the Iris cup 260, the Iris cup 400 includes an asymmetric transverse profile in which a posterior flange 410 is longer than an anterior flange 420. Therefore, the anterior flange 420 and the posterior flange 410 are shaped and configured to engage the anterior and posterior aspects of the Iris, respectively, in different sizes. Additionally, the Iris 400 cup includes a U-shaped 430 contact surface that is deeper (and therefore can provide more contact surface area) than the contact surface 210 of the Iris cup 120 illustrated in Fig. 3.

Again with reference to Fig. 1, the Iris cups 120 and the Iris cups 125 are substantially similar, except that each Iris cup 125 includes a tongue 128, which comprises a projection or edge extending towards the central opening 115 which provides the user with a grip surface for the pupil expander 100. Tab 128 allows the user to manipulate (ie, locate, replace, remove and / or move) the pupil expander during an ophthalmic procedure without having to make contact with the Iris. In the illustrated embodiment, the tongue includes an instrument coupling feature 450 in the form of a perforation that is sized to receive an appropriate positioning tool. In other embodiments, the tongue 128 may include any of a variety of instrument coupling features including, by way of non-exclusive example, grooves, projections, loops, and / or hooks. In alternative embodiments, the tongue 128 may be located on the support member 110 within the recess 130. The tabs 128, by providing separate contact surfaces, can also serve to protect the pupil expander 100 from damage while the pupil expander 100 is well contained within a container. In some embodiments, Iris cups 120 as such include instrument coupling characteristics that are substantially similar to instrument coupling characteristic 450. For example, in some embodiments, the iris cups 120 may include instrument coupling characteristics in the central portions 180 (illustrated in Fig. 2).

The pupil expander 100 may be shaped and configured to be transparent enough to provide visualization through the support element 110 and the iris cups 120 to observe, by way of non-exclusive example, the underlying tissue, the vessels, the air bubbles, and / or bleeding. In alternative embodiments, the support element 110 and / or the iris cups 120 may be semi-transparent or opaque in order to be clearly visible during ophthalmic procedures.

Figs. 9a-11 illustrate a method of using the pupil expander 100 in an eye 500 to stretch an iris 510 and expand a pupil 520 in accordance with an embodiment of the present disclosure. For simplicity, only two iris cups 120 are illustrated in Fig. 11. With reference to Figs. 9 and 11, after making an Incision of 2-4 mm (without polishing) either in a cornea 530, a sclera 535, or a limbus 540), the anterior chamber 545 is filled in a conventional manner with a viscoelastic fluid for prevent the cornea 530 from collapsing and to provide lubrication and support for the subsequent insertion of surgical instruments.

Referring to Fig. 9a, as the pupil expander 100 passes inwards and through a lumen 550 of an Administration Instrument 555, the support element 110 is in an unexpanded state. In an exemplary method, the user can advance the pupil expander 100 from the administration instrument 555 only to couple a more distal (user's) iris cup 125a against the iris 510. In some cases, the user can use a positioning instrument (without polishing) that is inserted either through the administration instrument 555 or through another incision (not illustrated) to couple the instrument coupling feature 450 of the tongue 128 (marked in Fig. 1) in the iris cup 125a to place the iris cup 125a against the iris 510. In other embodiments, the most distal iris cup may be one of the iris cups 120.

As illustrated in Fig. 9b, after the iris cup 125a is coupled to the iris 510, the user can advance the rest of the pupil expander 100 from the administration instrument 555 into the pupil 520. A As the pupil expander 100 emerges from the administration instrument 555 into the pupil 520, the support member 110 changes from the unexpanded configuration to an expanded configuration having a substantially circular shape. A positioning instrument (not shown) can be used to manipulate iris 510 and / or pupil expander 100 to locate iris cups 120, 125 around an internal margin 560 of iris 510. In some cases, the user may use the positioning instrument to couple the instrument coupling characteristics 450 of the tabs 128 in the iris cups 125a, 125 to relocate the pupil expander 100.

Figs. 10 and 11 illustrate the pupil expander 100 located inside the eye

500 to dilate pupil 520 in a substantially circular shape that mimics the original anatomical shape of the pupil. As illustrated in Fig. 10, all iris cups 120, 125 are located against the iris tissue, such that they stretch iris 510 and expand the pupillary diameter to a diameter D3, which exceeds

<img file="AR090584A1_D0002.tif" />

slightly the outer diameter D1 of the pupil expander as a result of the thickness of the central portions 180 of the iris cups 120, 125. The pupil expander 100 can keep the pupil 520 in a dilated state to provide wide access or viewing field during the ophthalmic procedure.

In some embodiments, as illustrated in Fig. 11, the flexibility of the iris cups 120, 125 allows the contact areas 210 of the iris cups to be in contact and comfortably surround the iris 510 in the margin Internal iris 560. In some embodiments, the iris cups

120, 125 can apply a compression force against the inner margin 560 of the iris 510, thereby stabilizing the pupil expander 100 against the iris tissue.

As illustrated in Fig. 11, the pupil expander 100 is configured to provide excellent self-retention against the eye, which allows the use of the hand-free and instrument-free pupil expander 100 during an ophthalmic procedure. . In other words, independent means to hold the pupil expander in place within the pupil 520 are not necessary. The self-retention nature of the pupil expander 100, provided by the shapes and contours of the iris cups 120,

125, eliminates the need for suture or support of the pupil expander 100 during use that the prior art pupil expansion ophthalmic devices often require.

When the procedures requiring dilation are completed, the inverse action of the insertion procedure depicted in Figs.

9a and 9b. For example, in some cases, the user can use a positioning instrument to grab the pupil expander 100 to couple the instrument coupling feature 450 of at least one of the tabs 128 to retract the pupil expander 100 into a cannula. (not illustrated) inserted into the eye 500. The cannula may be substantially similar to the administration instrument 555. As the pupil expander 100 retracts into the cannula, the pupil expander 100 changes from an expanded state to an unexpanded state. After retracting the entire pupil expander 100 in the cannula, the cannula, which carries the pupil expander 100 in an unexpanded state, can be removed from the eye 500.

Fig. 12 illustrates a schematic view of an exemplary administration / extraction instrument 6000 for inserting and / or removing the pupil expander in accordance with an embodiment of the present disclosure. As illustrated in Fig. 12, the administration / extraction instrument 600 includes a distal end 605 in communication with a lumen 610. The administration / removal instrument 600 includes an insertion rod or plunger 615 located longitudinally within the lumen 610. The pupil expander 100 is placed distal to a tip of the plunger 620 within the lumen 610 in an unexpanded state. In some embodiments, the administration / extraction instrument 600 is configured so that when the plunger 615 moves toward the distal end 605 of the administration / extraction instrument 600, the tip of the plunger 620 displaces the pupil expander 100 from the lumen 610, through the distal end 605, and into an eye. In some embodiments, as the pupil expander 100 emerges from the distal end 605, the pupil expander changes from an unexpanded state to a more expanded state in the manner described above.

In the embodiment illustrated in Fig. 13a, the plunger 615 includes a connector 630 located adjacent to the tip of the plunger 620. The connector 630 is shaped and configured to couple the pupil expander 100. The connector 630 can comprise any in a variety of ways including, by way of non-exclusive example, a hook, a loop, a projection, a rod, a spiral, a tongue, and a pin. In some embodiments, the connector 630 is shaped and configured to couple the instrument coupling feature 450 of the tongue 128 (marked in Fig. 1) of the pupil expander 100. In some embodiments, the coupling feature of instruments 450 and connector 630 are shaped and configured as a coupling pair of selectively removable fasteners. In other embodiments, the plunger does not include a connector.

In some embodiments, the connector 630 is fixedly attached to the plunger 615. In other embodiments, the connector 630 is selectively removable from the plunger 615, and can be used during only part of the pupil expansion procedure. The connector 630 may be coupled to the plunger 615 by any of a variety of fixing mechanisms including, by way of non-exclusive example, the use of one or more of an adhesive, a threaded coupling, a snap fit coupling, a coupling by friction, overmolding, heat contraction, heat welding, a hook and loop system, a coupling system, and / or any other mechanism that fixedly or selectively couples the connector 630 with the plunger 615.

The 630 connector may be constructed from any suitable biocompatible material. In some embodiments, the connector 630 is constructed from a structurally deformable biocompatible material that can be elastically or plastically deformed without compromising its integrity. For example, in the embodiment illustrated in Fig. 13b, the connector 630 includes a hook 632 extending from an expandable metal ring 634 that can be selectively attached to the plunger 615. Said metal ring can £

stretch to encircle the tip of the plunger 620 and relax to grasp the tip of the plunger 620 and temporarily secure the connector 630 to the plunger 615.

In some embodiments, connector 630 is used during removal of the pupil expander from one eye. The connector 630 can be selectively coupled to the plunger 615 before insertion (or re-insertion) of the administration / removal instrument of the pupil expander 600 into the eye (i.e., before performing the reverse action of the insertion procedure represented in Figs. 9a and 9b). The administration / extraction instrument 600 may be placed within an eye in a manner substantially similar to the placement of the Administration Instrument 555 in Figs. 9a and 9b. For example, in some cases, the user may use the connector 630 to grip the pupil expander 100 by attaching the instrument coupling feature 450 of at least one of the tabs 128 before retracting the pupil expander 100 in the lumen 610 of the administration / extraction instrument 600. After the power-driven extraction of the entire pupil expander 100 from the eye, the administration / extraction instrument 600, which transports the pupil expander 100 in an unexpanded state in lumen 610, can be removed from the eye.

Figs. 14 and 15 illustrate an example of an administration / removal instrument of the pupil expander 650 in accordance with an embodiment of the present disclosure. In some cases, aspects of the pupil expander administration / removal instrument include features disclosed in US Pat. No. 12 / 249,996, entitled Automated Infraocular Lens Injector Devlce, filed October 13, 2008, and US Patent Application. No. 12 / 763,322, entitled Modular Infraocular Lens Injector Device, filed on April 20, 2010, whose references are incorporated herein in its entirety.

In the illustrated embodiment, the administration / extraction instrument 650 includes a cable assembly 655, a housing 660, a distal portion 663, and a distal end 665. The cable assembly 655 carries power and / or control signals. of an independent user console (not illustrated). The administration / extraction instrument 600 includes a plunger 667 that is located longitudinally within a lumen 669 of the housing 660. The plunger 667 is configured to move longitudinally out of and towards the distal end 665. The administration / extraction instrument 650 also comprises a cartridge holder 670 in the distal portion 665, which holds a detachablely mounted Insert cartridge 675.

The Insert cartridge 675 is shaped and configured to accommodate a pupil expander 100. In some embodiments, the Insert cartridge 675 Includes an Identifier that allows the injection apparatus 650 to recognize the contents of the Insert cartridge 675. The identification mechanism may comprise any of a variety of identification mechanisms including, without limitation, a radio frequency Identifier tag, an electronic product code, and a barcode. For example, the Identifier may inform the Injection apparatus if the Insertion cartridge carries a pupil expander or a different eye device such as, by way of non-exclusive example, an Infraocular lens. In some cases, the Identifier may inform the Administration / Extraction Instrument what particular type or size of pupil expander is transported in the Insertion cartridge. Such Identification information may allow the administration / extraction instrument to conveniently adapt its insertion and extraction procedures.

Fig. 16 illustrates a partially cropped perspective view of an exemplary drive mechanism 680 of the administration / removal instrument of the pupil expander 650 illustrated in Fig. 14. In addition to the plunger 667, the drive mechanism 680 includes an actuator 685 configured for longitudinal transfer within a tubular coupler 690 and an electric drive system 695. In some embodiments, the electric drive system 695 includes an electric motor. The drive mechanism 680 is configured to linearly move the plunger 667 along a longitudinal axis LA of the housing 660. The drive mechanism 680 allows the power-driven insertion of the pupil expander 100. In some embodiments, the drive mechanism 680 also allows the power-driven extraction of the pupil expander 100.

For example, going back to Figs. 14 and 15, as the plunger 667 moves through the insert cartridge 675, the pupil expander 100 moves toward the distal end 665. As the pupil expander 100 exits the administration / extraction instrument 650 a through the distal end 665, the pupil expander 100 changes from an unexpanded state to an expanded state.

When the procedures requiring dilation are completed, the administration / extraction instrument 650 can be used to remove or remove the pupil expander 100 from the eye.

The drive mechanism 680 allows the plunger 667 to move again through the insert cartridge 675, thereby retracting the pupil expander 100 from the eye into the lumen 610. As the plunger 667 moves backward, pupil expander 100 is removed longitudinally through lumen 610 from distal end 665. As

On / that the pupil expander 100 retracts into the lumen 610, the pupil expander 100 changes from an expanded state to an unexpanded state. In some embodiments, the automatic extraction mechanism of the administration / extraction instrument 650 operates in an inverse manner but similar to the automatic insertion mechanism described in US Pat. No. 12 / 249,996 and U.S. Patent Application No. 12 / 763,322, whose references were incorporated herein in its entirety previously.

After power-driven extraction of the entire pupil expander 100 from the eye, the administration / extraction instrument 650, which transports the pupil expander 100 in an unexpanded state in lumen 610, can be manually removed from the eye.

The various embodiments of the pupil expander of the present disclosure may be configured as single-use pupil expanders that are intended to be discarded after a single use, thereby allowing a new pupil expander for each new patient. Therefore, the pupil expander can be previously sterilized before being sent to an end user and ready to use after it is received by the end user. After a single use, the pupil expander can be discarded. Single-use pupil expanders ensure a sterile pupil expander for each patient without the need for sterilization by the end user (i.e., the surgeon), thus increasing the efficiency and safety of the ophthalmic procedure. In addition, the configuration as a single-use pupil expander allows the manufacture of the surgical pupil expander at a lower cost because the disposable lens can be constructed from a relatively inexpensive biocompatible material.

The various embodiments of the pupil expander described herein can use a shape memory ring with iris cups to dilate a pupil and keep the pupil in a dilated state during an ophthalmic surgery or procedure. The pupil expanders described herein may assume an unexpanded state to facilitate its nontraumatic insertion and removal of an eye through a primary incision, and may assume a predetermined expanded state within the eye. Also, the various embodiments of the pupil expander described herein can stabilize and self-retain its position in one eye and move with the eye as necessary during a surgical or diagnostic procedure. Although the various embodiments of the pupil expander described herein can be used without the aid of a positioning instrument, in some embodiments, the embodiments of the pupil expander can be used in conjunction with an instrument of positioning to provide greater control and / or maneuverability of the pupil expander in the eye.

Persons of ordinary skill in the art will appreciate that the embodiments included in the present disclosure are not limited in particular to the exemplary embodiments described above. In this regard, although the illustrative embodiments have been shown and described, a wide range of modifications, changes, substitutions are contemplated in the previous disclosure. It is understood that said variants of the foregoing may be carried out without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be interpreted broadly and in a manner consistent with the present disclosure.