SCLERAL FIXATION DEVICE FOR INTRAOCULAR LENS SUPPORT AND SURGICAL METHODS FOR THE INSERTION OF THE DEVICE

Abstract

A scleral fixation device for intraocular lens support (Arrieta's Holder) including: a receptacle and a plurality of Arrieta's Supports from the receptacle to the sclera, and surgical methods of inserting the device.

Claims

1. A scleral fixation device for an intraocular lens support comprising: a receptacle, and a plurality of clamping arms the receptacle to the sclera.

2. The device of claim 1, wherein the receptacle includes: an anterior part shaped as a circumference, a posterior part shaped as a circumference, and an equatorial ring located between the anterior part and the posterior part, the anterior part is placed on the front side of the device and posterior part is placed on the back side of the device, the anterior and the posterior parts act as covers to the equatorial ring: wherein the anterior part and the posterior part include a perforation on a center point; an intraocular lens housed in adefined space between the anterior and posterior parts.

3. The device of claim 2, wherein the equatorial ring has, radially on its edges, a plurality of holes in which the damping arms are inserted.

4. The device of claim 3, wherein the clamping arms have an elongated shape with a widening of its section at the proximal end for the purposes of insertion and retention in the equatorial ring, and another widening in its section at the distal end, to be fixed in the sclera preventing radial or axial displacement of the intraocular device.

5. The device of claim 4, characterized in that the Arrieta's Supports have their ends with a flattened disk shape, conical shape or other shape that allows their fixation to the eye tissue.

6. (canceled)

7. The device of claim 16, wherein the intraocular lens (IOL) is a monofocal, a multifocal, or a toric multifocal lens.

8. A surgical method of inserting the device of claim 1, the method is performed by an internal ab route according tothe following steps: a placeinge 30 G valved trocars to perform a vitrectomy of the entire vitreous base and then leave the irrigation on so that the intraocular pressure is maintained at an optimal value; b. performing 3 paracentesis of 1 mm at hours 1, 4, and 8; c. makinge a 2 mm corneal incision between 10 and 11 hours, through which the intraocular device will be injected; d. placnning viscoelastic in the anterior chamber to protect the endothelium; e. injecting the intraocular device through the 2.2 mm corneal incision, through which the injector of the intraocular device is introduced to be positioned at the level of the iris plane and then temporarily hold it at its distal end with forceps through the 1-hour 1-mm paracentesis; f. inserting the injector of the internal Arrieta's Supports with them placed at its distal end, through the 2.2 mm corneal incision and thread the most distal hole of the intraocular support with the internal Arrieta's Support made of PMMA (polymethacrylate) and then insert it in the scleral thickness, crossing the ciliary body in the valleys of its folds, g. once the internal Arrieta's Supports have reached a depth of 90% of the scleral thickness, release the internal Arrieta's Support so that it is fixed to the sclera at its widened or umbrella-shaped distal end that prevents recoil and where its proximal end is holding the intraocular device at the level of the injection hole because its base is wider than its body and wider than the holes of the intraocular device, h. repeating the procedure to place at least two more Arrieta's Supports, all at the same depth and each one, preferably 120 degrees from the previous one with the same maneuver; to place the internal Arrieta's Support at hour 2, the forceps are inserted through the paracentesis at hour 8, and to place the internal Arrieta's Support for hour 10, the paracentesis at hour 4 is extended to 2.2 mm to introduce the injector of the internal Arrieta's Support and the forceps is held through the 1 hour paracentesis, with which the intraocular device is fixed to the sclera in three equidistant areas and fixed to the sclera by internal ab route, without communicating with the outside, to avoid being a gateway to germs and not cause erosion of the conjunctiva by decubitus.

9. A surgical method of inserting the device of claim 1, the method is performed by an external ab route according to the following steps: a. making opening of the conjunctiva 3 mm wide at 2 mm from the limbus at 10, 2, and 6 hours; b. creating 3 scleral pockets at 2 mm from the limbus, 2 mm wide by 2 mm long and at a depth of 400 um at hours 10, 2, and 6; c. placing 30 G valved trocars to perform a vitrectomy of the entire vitreous base and then leave the irrigation on so that the intraocular pressure is maintained at an optimal value; d. performing 3 paracentesis of 1 mm at hours 1, 4, and 8; e. making a a 2.2 mm corneal incision between 10 and 11 hours, through which the intraocular device will be injected; f. place viscoelastic in the anterior chamber to protect the endothelium; g. injecting the intraocular device through the 2.2 mm corneal incision, with the intraocular device injector to be positioned at the level of the iris plane and then transiently hold its distal end with a forceps through the 1 mm paracentesis at hour 1; h. inserting the injector of the external Arrieta's Supports with it placed at its distal end, through the 6 hour scleral pocket, drilling the sclera into the vitreous cavity with the injector that has a 30 G metal shaft with a sharp point for drilling the sclera and then introduce the external Arrieta's Support into the 6-hour hole of the intraocular device, which is held by the 1-hour forceps, with which the external Arrieta's Support is fixed to the intraocular device by the umbrella shape that prevents it from recoiling; i. releasnge the external Arrieta's Support, which remains fixed to the sclera by its wider base that prevents it from deepening, leaving this base in the scleral pocket that was previously constructed; j. repeating the procedure to place at least two more arms, all at the same depth and each one, preferably 120 degrees from the previous one with the same maneuver, k. placing the external Arrieta's Support at hour 2, the forceps are inserted through the paracentesis at hour 8 and to place the external Arrieta's Support at hour 10, the paracentesis of hour 4 is used, with which the intraocular device is fixed to the sclera in three areas and equidistantly fixed to the sclera via the external ab route and then the conjunctiva is closed with 8.0 silk.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0066] These Figures are included by way of illustration and do not limit the present invention in any way.

[0067] FIG. 1: Perspective view of the human eye with the Arrieta's Holder in place.

[0068] FIG. 2: Right side view of the human eye with the Arrieta's Holder in place.

[0069] FIG. 3: Perspective view of the Arrieta's Holder with its Arrieta's Support deployed.

[0070] FIG. 4: Front, side T-T view of the Arrieta's Holder, Section T-T of the Arrieta's Holder with its Arrieta's Internal Supports deployed and Detail U scale 10:1.

[0071] FIG. 5: Front, side and bottom view of the Arrieta's Support of the Arrieta's Holder with sectional view L-L.

[0072] FIG. 6: Perspective view of the Arrieta's Support of the Arrieta's Holder.

[0073] FIG. 7: Perspective view of the Arrieta's Support of the Arrieta's Holder.

[0074] FIG. 8: Front, side and bottom view of the Arrieta's Support positioning device of the Arrieta's Holder.

[0075] FIG. 9: Perspective view of the positioning device of the Arrieta's Support of the Arrieta's Holder.

[0076] FIG. 10: Additional perspective view of the positioning device of the Arrieta's Support of the Arrieta's Holder.

[0077] FIG. 11: Front view and I-I section and bottom view with J-J section of the Arrieta's.

DETAILED DESCRIPTION OF THE INVENTION

[0078] The scleral fixation device for intraocular lens support (Arrieta's Holder) of the present invention comprises:

[0079] an Arrieta's Holder receptacle itself and

[0080] a plurality of Arrieta's Supports from receptacle to sclera.

[0081] Said Arrieta's Holder is characterized by being a receptacle where the IOL (intraocular lens) is contained, where said receptacle (1) consists of two faces facing each other, the anterior face (2) and posterior face (2bis) which are joined by an equatorial ring (10). See FIGS. 3 and 4.

[0082] The faces (2) and (2bis) are joined in the ring (10) in such a way as to define a cavity (4), which will contain the IOL. See FIGS. 3 and 4.

[0083] The faces (2) and (2bis) will have an anterior central hole (8) and a posterior central hole (8bis) in such a way as to allow the passage of light so that the IOL can fulfill its function.

[0084] For construction purposes, faces (2) and (2bis) in the space occupied between their outer perimeter and the central hole, have anterior connecting bridges (11) and posterior connecting bridges (11bis), such as those seen in FIGS. 3, 4.

[0085] In the equatorial ring (10) there are at least twelve perforations (7), which allow the fixation of the Internal Arrieta's Supports (3) and External Arrieta's Support (3bis). See FIGS. 3 and 4.

[0086] The Internal Arrieta's Supports (3) and External Arrieta's Support (3bis) have a widened disk-shaped shape at one end (5) and an arrow-shaped shape at the other end (6). See FIGS. 5 and 6.

[0087] The fixation of the Internal Arrieta's Supports (3) and External Arrieta's Support (3bis) (see FIGS. 5 and 6) in the Arrieta's Holder device (1) can be done at either of its two ends.

[0088] FIG. 8 refers to the placement device (9) of the Internal Arrieta's Support (3) and External Arrieta's Support (3bis). It is a device that has an internal metal stem (6bis) (see FIGS. 5 and 6), which guides the Arrieta's Support; when the Arrieta's Support is loaded in the injector, the stem is inside the internal conduit of the Arrieta's Support and serves as guide for the injection of the same. Once the Arrieta's Support is placed in the desired position, the stem is withdrawn from the Arrieta's Support through a recoil of the same that occurs when we press on the supports, which are placed on the tips of the index and thumb fingers in the time of injection. Said placement device (9) is outside the scope of the present invention and is mentioned for the purpose of fully understanding the placement procedure.

[0089] The Arrieta's Holder of the present invention is made of polymethacrylate, silicone, acrylic or other material suitable for insertion into the human body and has dimensions that range from 10 to 14 mm in length and 3 to 6 mm in thickness.

[0090] The method for its placement in the patient's eye is as follows:

Placement of the Arrieta's Holder Ab Internal (from Inside to Outside)

[0091] 30 G valved trocars are placed to perform a vitrectomy of the entire vitreous base and then the irrigation is left on to maintain the 10P at an optimal value.

[0092] 3 paracentesis of 1mm are performed at hours 1, 4 and 8.

[0093] A 2 mm corneal incision is made between 10 and 11 hours, through which the Arrieta's Holder of the present invention will be injected.

[0094] Viscoelastic is placed in the Anterior Chamber to protect the endothelium.

[0095] The Arrieta's Holder is injected through the 2.2 mm corneal incision, through which the Arrieta's Holder injector is introduced to be positioned at the level of the plane of the iris and is then temporarily held from its distal end with forceps through of the 1 mm paracentesis at hour 1. The injector of the internal Arrieta's Supports (3) is inserted with the same placed at its distal end, through the 2.2 mm corneal incision and the most distal hole of the Arrieta's Holder is threaded with the internal Arrieta's Support (3) to then enter the scleral thickness, crossing the ciliary body in the valleys of its folds. Once the internal Arrieta's Supports (3) have reached a depth of 90% of the scleral thickness, the internal Arrieta's Support (3) is released so that it is fixed to the sclera by its umbrella shape that prevents recoil and its basal end remains supporting the Arrieta's Holder at the level of the injection hole because its base is wider than its body and wider than the holes of the Arrieta's Holder.

[0096] Then the procedure is repeated to place two more supports, all at the same depth and each preferably at 120 degrees from the previous one with the same maneuver. The quantity and angular arrangement of the Arrieta's Supports is at the discretion of the surgeon.

[0097] To place the internal Arrieta's Support (3) of hour 2, the forceps are introduced through the paracentesis at hour 8 and to place the internal Arrieta's Support (3) of hour 10 the paracentesis of hour 4 is extended to 2.2 mm to insert the internal Arrieta's Support (3) and the forceps is held through the 1-hour paracentesis. With this, the Arrieta's Supports are fixed to the sclera in three equidistant areas and fixed to the sclera by internal ab route, without reaching to have communication with the outside, to avoid being a gateway to germs and not causing erosion of the conjunctiva by decubitus.

[0098] It is sufficient to place only three internal Arrieta's Supports (3) but six or more can be placed as desired by the surgeon. The idea is that these internal Arrieta's Supports (3) are not removed but if it is necessary to remove the Arrieta's Holder, the base of the Arrieta's Supports can be cut off, thereby freeing it to extract the Arrieta's Holder or to place it in another position, if necessary.

Placement of the Arrieta's Holder ab External (from Outside to Inside)

[0099] A 3 mm wide opening of the conjunctiva is made 2 mm from the limbus at 10, 2, and 6 hours. 3 scleral pockets are created 2 mm from the limbus, 2 mm wide by 2 mm long and at a depth of 400 um at hours 10, 2, and 6.

[0100] 30 G valved trocars are placed to perform a vitrectomy of the entire vitreous base and then the irrigation is left on to maintain the IOP at an optimal value.

[0101] 3 paracentesis of 1mm are performed at hours 1, 4, and 8.

[0102] A 2.2 mm corneal incision is made between 10 and 11 hours, through which the Arrieta's Holder will be injected.

[0103] Viscoelastic is placed in the anterior chamber to protect the endothelium.

[0104] The Arrieta's Holder is injected through the 2.2 mm corneal incision, with the Arrieta's Support injector to be positioned at the level of the iris plane and then temporarily held from its distal end with a forceps through the paracentesis of 1 mm of hour 1. The injector of the external Arrieta's Supports (3bis) is introduced with the same placed in its distal end, through the scleral pocket of hour 6, the sclera is perforated towards the vitreous cavity with the injector that has a 30 G metal shaft with a sharp tip to pierce the sclera and then the external Arrieta's Support (3bis) is inserted into the 6 hour hole of the Arrieta's Holder, which is held by the 1 hour forceps, with this the external Arrieta's Support (3bis) remains fixed to the Arrieta's Holder by the umbrella shape that prevents its backward movement.

[0105] The external Arrieta's Support (3bis) is released, which remains fixed to the sclera by its wider base that prevents it from deepening, leaving this base in the scleral pocket that was previously constructed.

[0106] Then the procedure is repeated to place two more supports, all at the same depth and each one, preferably at 120 degrees from the previous one with the same maneuver. The quantity and angular arrangement of the Arrieta's Supports are at the discretion of the surgeon.

[0107] To place the external Arrieta's Supports (3bis) at hour 2, the forceps are introduced through the paracentesis at hour 8 and to place the external Arrieta's Supports (3bis) at hour 10, the paracentesis at hour 4 is used. Thus, the Arrieta's Holder is fixed to the sclera in three equidistant areas and fixed to the sclera by external ab via and then the conjunctiva is closed with 8.0 silk.

[0108] It is enough to place only three external Arrieta's Supports (3bis) but six or more can be placed as desired by the surgeon. The idea is that these external Arrieta's Supports (3bis) are not removed but if it is necessary to remove the Arrieta's Holder, the base of the external Arrieta's Supports (3bis) can be cut, which would be released to extract the Arrieta's Holder or to place it in another position, if necessary.

[0109] Among the advantages and solutions provided by the device of the present invention, the following can be mentioned:

[0110] 1. It does not cause a decrease in corneal endothelial cells due to the proximity or contact of the IOL with the endothelium as occurs with the Anterior Chamber IOLs.

[0111] 2. It does not cause iris atrophy in the IOL fixation area, since it is not fixed to iris but to sclera, as occurs with AC IOLs in its Iris-Claw models, either in its versions fixed in the anterior iris face or its version fixed in the posterior iris face.

[0112] 3. It does not cause ovalizations of the pupil (cat's eye), since it is not fixed to iris but to sclera, as occurs in the case of AC IOLs in its Iris-Claw models, either in its versions fixed in the anterior iris face or its version fixed in the posterior iris face.

[0113] 4. In the case of zonular weakness that occurs during cataract surgery or in cases that already existed previously, but the surgeon notices it during cataract surgery, the IOL chosen for that patient should usually be changed for another Anterior Chamber AC IOL. If the surgeon does not have that other AC IOL with the exact measure for that patient at the time of surgery, a second surgical act should be planned at another date when the appropriate 3 AC IOL is obtained for the patient. In the case of having a device of the present invention (Arrieta's Holder), the surgeon can use the same IOL that he had planned to use with that patient and resolve the situation in the same surgical act, and not have to wait for another date to do a second surgery to place the iris fixed AC IOL. In addition, for the surgeon to have a second replacement AC IOL at the time of surgery with the same diopter required by the patient, it implies having a stock of IOLs of many different sizes on hand in the operating room, which in turn implies a very high cost in supplies destined only for those occasional cases in which it is necessary to use these AC IOLs, and it also continues being an alternative IOL, which is not the one that the surgeon chose to use for that patient, due to various particular characteristics of that case.

[0114] 5. IOLs fixed to the sclera have a theoretical advantage over other techniques with respect to complications, especially in eyes with a history of trauma and in young patients.