MEDICAL DEVICE FOR GLAUCOMA SURGERY WITH CONTROLLED AND MODULABLE FILTRATION

Abstract

A medical device for glaucoma surgery includes a tubular body provided with a through cavity extending from a proximal end to a distal end. The tubular body has a first proximal positioning means at the proximal end, and a second distal positioning means at the distal end. The tubular body has at least one proximal filtration hole, located on the side of the proximal end, and at least one distal filtration hole, located on the side of the distal end, the proximal and distal holes being fluidically connected to each other by the through cavity. The proximal and distal filtration holes are at least partially or completely occluded by a membrane made of resorbable material at least partially removable by selective action, so as to allow selective variation of the amount of aqueous humor flow removable via the through cavity.

Claims

1. A medical device for glaucoma surgery, the medical device comprising: a tubular body comprising a through cavity extending from a proximal or intraocular end to a distal or extraocular end, wherein: at the proximal or intraocular end, the tubular body comprises a first proximal positioning means of the medical device, at the distal or extraocular end, the tubular body comprises a second distal positioning means of the medical device, the tubular body comprises at least one proximal filtration hole, located on a side of the proximal or intraocular end, and at least one distal filtration hole, located on the side of the distal or extraocular end, said at least one proximal and distal filtration holes, being fluidically connected to each other by said through cavity, and said at least one proximal and distal filtration holes are at least partially or completely occluded by a membrane at least partially removable by selective action, so as to allow a selective variation of an amount of aqueous humor flow removable via said through cavity.

2. The medical device of claim 1, wherein said membrane is perforable or removable by a stylet and/or by application of a laser source.

3. The medical device of claim 1, wherein said membrane is a mobile membrane allowing patency of at least one corresponding proximal or distal filtration hole to be varied.

4. The medical device of claim 1, wherein said membrane is resorbable in contact with aqueous humor in a predetermined time range.

5. The medical device of claim 1, wherein the through cavity has a through width or lumen with an internal diameter ranging between 40 and 140 microns.

6. The medical device of claim 1, wherein the at least one proximal filtration hole is located at the proximal or intraocular end and wherein the at least one distal filtration hole is located on an upper and/or upper-rear and/or upper-lateral surface of the tubular body.

7. The medical device of claim 1, wherein the tubular body comprises a plurality of distal filtration holes having increasing diameter moving from the distal or extraocular end towards the proximal or intraocular end.

8. The medical device of claim 1, wherein the tubular body comprises a plurality of distal filtration holes at least partially located on opposite sides with respect to a median plane (M-M) of the tubular body.

9. The medical device of claim 1, wherein the tubular body, with respect to a section plane perpendicular to a prevailing direction of extension of the medical device connecting the proximal or intraocular end to the distal or extraocular end, has an at least partially concave section at a side or lower face suitable for interfacing with an ocular sclera.

10. The medical device of claim 1, wherein the tubular body, with respect to a section plane perpendicular to a prevailing direction of extension of the medical device connecting the proximal or intraocular end to the distal or extraocular end, has a convex, elliptical or parabolic section, at a side or upper face suitable for interfacing with a conjunctiva.

11. The medical device of claim 1, wherein the first proximal positioning means of the tubular body comprises a pair of rings or positioning protuberances arranged in positions diametrically opposite to the tubular body, and wherein said pair of rings or positioning protuberances are axially spaced from each other by a distance of between 0.5 mm and 3 mm, so as to position themselves astride the sclera-cornea junction.

12. The medical device of claim 1, wherein the second distal positioning means comprises a pair of positioning and attachment tabs for positioning and attaching to the ocular sclera, wherein said positioning and attachment tabs are arranged in positions diametrically opposite to the tubular body.

13. The medical device of claim 12, wherein said positioning and attachment tabs are provided with seats for receiving suture threads.

14. The medical device of claim 12, wherein said positioning and attachment tabs are smooth and shaped so as to be inserted into scleral pockets without sutures.

15. The medical device of claim 11, wherein the second distal positioning means comprises a pair of positioning and attachment tabs and wherein the positioning rings or protuberances and the positioning and attachment tabs are aligned angularly with each other with respect to the tubular body.

16. The medical device of claim 1, wherein the tubular body comprises a first proximal tract, provided with the first proximal positioning means, and a second distal tract, provided with the second distal positioning means, said first proximal and second distal tracts being rectilinear, respectively, along a first and second prevailing directions (X-X, Y-Y), said first and second prevailing directions (X-X, Y-Y) being inclined with each other by an angle of deflection ranging between 25 and 45 degrees.

17. The medical device of claim 1, wherein the tubular body comprises a first proximal tract, provided with the first proximal positioning means, and a second distal tract, provided with the second distal positioning means, said first proximal and second distal tracts being directed respectively along a first and a second prevailing directions (X-X, Y-Y), wherein said second distal tract is slightly curved according to curvature radius of the sclera in the second prevailing direction.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Further features and advantages of the present invention will be more comprehensible from the following description of preferred embodiments given by way of non-limiting examples, in which:

[0024] FIG. 1 shows a perspective view of a medical device for glaucoma surgery according to an embodiment of the present invention;

[0025] FIG. 2 shows a lateral view of the device of FIG. 1 from the side of arrow II indicated in FIG. 1;

[0026] FIG. 3 is a lateral view of the medical device of FIG. 1 from the side of arrow III indicated in FIG. 1;

[0027] FIG. 4 is a lateral view of the medical device of FIG. 1 from the side of arrow IV indicated in FIG. 1;

[0028] FIGS. 5-6 show a perspective view and a lateral view, respectively, of a medical device for glaucoma surgery according to a further embodiment of the present invention;

[0029] FIG. 7 shows a front perspective view of a medical device for glaucoma surgery according to a further embodiment of the present invention;

[0030] FIG. 8 shows a perspective view of the front detail VIII of the medical device for glaucoma surgery of FIG. 7;

[0031] FIG. 9 shows a rear perspective view of the medical device for glaucoma surgery of FIG. 7;

[0032] FIG. 10 shows a top view of the medical device for glaucoma surgery of FIG. 7;

[0033] FIG. 11 shows a lateral view of the medical device for glaucoma surgery of FIG. 7; and

[0034] FIGS. 12a-12b show sectional views of a medical device for glaucoma surgery of the prior art and of a medical device for glaucoma surgery according to the present invention applied to a sclera, respectively.

[0035] Elements or parts in common to the embodiments described will be indicated hereafter using the same reference numerals.

DETAILED DESCRIPTION

[0036] With reference to the aforementioned figures, reference numeral 4 globally indicates a medical device for glaucoma surgery.

[0037] The medical device 4 comprises a tubular body 8 provided with a through cavity 12 extending from a proximal or intraocular end 16 to a distal or extraocular end 20. The tubular body 8 may be made of plastic, polymeric, metal, hypoallergenic, biocompatible material and the like.

[0038] The tubular body 8 comprises at least one proximal filtration hole 24, located on the side of the proximal end 16, and at least one distal filtration hole 28, located on the side of the distal end 20.

[0039] Said proximal and distal filtration holes 24, 28 are fluidically connected to each other by the through cavity 12. In other words, the through cavity 12 puts the at least one proximal filtration hole 24, located on the side of the proximal end 16, and the at least one distal filtration hole 28, located on the side of the distal end 20, in fluid communication with each other.

[0040] Preferably, the at least one proximal filtration hole 24 is located at the proximal end 16, and the at least one distal filtration hole 28 is located on an upper and upper-lateral surface 36 of the tubular body 8. The at least one distal filtration hole 28 may be located on a rear surface 38 of the tubular body 8.

[0041] By at least one hole it is meant that it is possible to provide a single filtration hole 24, 28 or also a plurality of filtration holes 24, 28. The plurality of filtration holes may comprise a set of holes arranged according to geometric patterns adapted to promote an adequate dispersion of the drained liquid through the through cavity 12.

[0042] According to a possible embodiment, the through cavity 12 has a passage width or lumen having an internal diameter ranging between 40 microns and 140 microns.

[0043] Preferably, the tubular body 8, with respect to a section plane perpendicular to a prevailing direction of extension of the medical device 4 which connects the proximal or intraocular end 16 with the distal or extraocular end 20, has an at least partially concave section 22 at a side or lower face 23 suitable for interfacing with an ocular sclera 25. FIGS. 12a and 12b illustrate the interaction between the tubular body 8 and the sclera 25 in a solution of the prior art (FIG. 12a) and in a solution according to the present invention (FIG. 12b). In the solution of the prior art (FIG. 12a), the tubular body 8 has a circular section and, therefore, it imprints the underlying sclera 25 in an ideally point-like manner. In this way, the contact pressure is relatively high. On the other hand, in the solution according to the present invention (FIG. 12b), the tubular body 8 has an at least partially concave section 22 at a side or lower face 23. In this way, the tubular body 8 may rest on the sclera 25 in a more uniform manner due to an overall wider support surface, so as to distribute the contact pressure over a wider area of sclera 25.

[0044] According to an embodiment of the present invention, the tubular body 8, with respect to a section plane perpendicular to a prevailing direction of extension of the medical device 4 which connects the proximal or intraocular end 16 to the distal or extraocular end 20, has a convex, elliptical or parabolic section, at a side or upper face 27, suitable for interfacing with the conjunctiva 29. Also in this case, with respect to the point-like contact area of the circular solutions of the prior art (FIG. 12a), the present invention (FIG. 12b) allows obtaining a more rounded or less steep course of the conjunctiva 29 above and a more uniform contact pressure between the conjunctiva 29 and the upper face 27 of the tubular body 8. A more rounded soft course means a wider curvature that allows increasing the surfaces in mutual contact and, therefore, decreasing the specific contact pressure between them.

[0045] According to a possible embodiment (FIGS. 7-11), the tubular body 8 comprises a plurality of distal filtration holes 28 having different diameters. In particular, said distal filtration holes 28 have an increasing diameter moving from the distal end 20 towards the proximal end 16. Said distal filtration holes 28 with variable diameter allow choosing the quantity of filtration flow based on the pressure of the individual patient. They also allow a progression of the amount of flow, as the ophthalmologist can begin to open the distal filtration hole 28 with a smaller diameter and then subsequently act on, for example, one or two holes of greater diameter if the intraocular pressure conditions require it.

[0046] Furthermore, according to a possible embodiment (FIGS. 7-11), said distal filtration holes 28 are at least partially located on opposite sides with respect to a median plane M-M of the tubular body 8 so as to allow, by means of differentiated openings, having a flow directed more to the left or to the right of said median plane M-M of the tubular body 8.

[0047] Advantageously, said proximal and distal filtration holes 24, 28 are at least partially or completely occluded by a membrane 32 which can be at least partially removed by selective action, so as to allow selective variation of the amount of aqueous humor flow removable via said through cavity 12.

[0048] According to a possible embodiment, said membrane 32 is a membrane that can be perforated or removed by means of a stylet.

[0049] According to a possible embodiment, said membrane 32 is a membrane that can be perforated or removed by application of a laser source from the outside.

[0050] According to a further possible embodiment, said membrane 32 is a mobile membrane allowing patency of the corresponding at least one proximal or distal occluding filtration hole 24, 28 to be varied.

[0051] According to a further possible embodiment, said membrane 32 is a resorbable membrane in contact with aqueous humor. The reabsorption of the membrane can be established or predetermined in a predetermined time, not being instantaneous. This predetermined time can be varied at will by acting, for example, on the size and/or thickness and/or material of the reabsorbable membrane 32.

[0052] It should be noted that the embodiments of membrane 32 described above are not necessarily alternative to each other; in other words, they may coexist in the same embodiment.

[0053] For example, the membrane 32 can be perforated and removed by a stylet and/or by a laser source. It can also be mobile and/or resorbable in contact with aqueous humor in a time predetermined by the features of the resorbable material and/or by the geometry of the membrane.

[0054] All the aforementioned embodiments constitute alternative or synergistic variants which allow exactly dosing or calibrating the overall patency of the medical device 4 and, therefore, the aqueous humor drainage/filtering capacity.

[0055] According to an embodiment, at the proximal end 16, the tubular body 8 comprises a first proximal positioning means 40 of the medical device 4, while, on the side of the distal end 20, the tubular body 8 comprises a second distal positioning means 44 of the medical device 4.

[0056] According to an embodiment, the first proximal positioning means 40 of the tubular body 8 comprises a pair of rings or positioning protuberances 48.

[0057] According to an embodiment, said rings or positioning protuberances 48 are arranged in positions diametrically opposite to the tubular body 8 itself.

[0058] For example, said rings or positioning protuberances 48 are axially spaced from each other by a distance of between 0.5 and 3 mm, so as to position themselves astride the sclera-cornea junction. This conformation allows the medical device 4 to remain in place in the irido-sclero-corneal junction, preventing it from being displaced intraocularly or being extruded out of the eye.

[0059] According to an embodiment, the second distal positioning means 44 comprises a pair of positioning and attachment tabs 52 for positioning and attaching to the ocular sclera. These positioning and attachment tabs 52 allow the medical device 4 to remain in place, preventing it from moving on the sclera and causing a dislocation thereof with respect to the design working position at the level of the irido-sclero-corneal junction.

[0060] Preferably, said positioning and attachment tabs 52 are arranged in positions diametrically opposite to the tubular body 8.

[0061] According to a possible embodiment, said positioning and attachment tabs 52 are provided with seats 56 for receiving suture threads.

[0062] According to a further possible embodiment, said positioning and attachment tabs 52 are smooth, that is, without said seats 56, and are shaped in such a way as to be able to be inserted in scleral pockets without sutures.

[0063] Preferably, the rings or positioning protuberances 48 and the positioning and attachment tabs 52 are angularly aligned with each other with respect to the tubular body 8.

[0064] According to an embodiment, the tubular body 8 comprises a first proximal tract 60, provided with the first proximal positioning means 40, and a second distal tract 64, provided with the second distal positioning means 44.

[0065] According to a possible embodiment, said first proximal tract 60 and second distal tract 64 are rectilinear, respectively, along a first prevailing direction X-X and a second prevailing direction Y-Y, preferably inclined with each other by an angle of deflection 68 between 25 and 45 degrees. In this way, the tubular body 8 is able to position itself radially along the sclera.

[0066] According to a further embodiment, the profile of said second distal tract 64 is slightly curved according to the radius of curvature of the sclera in the prevailing direction Y-Y.

[0067] For example, the first proximal tract 60 has an extension along the first prevailing direction X-X between 1.5 and 3.5 mm, while the second distal tract 64 has an extension along the second prevailing direction Y-Y between 6 and 9 mm.

[0068] The method of use and the operation of the medical device according to the present invention will now be described.

[0069] In particular, the device is positioned on the side of its proximal end 16 at the irido-sclero-corneal junction of the patient.

[0070] The flow of aqueous humor, exiting the eye through the medical device 4, begins when the reabsorption of the reabsorbable membrane/cap 32 occurs at the level of the endocular hole or the proximal filtration hole 24 (or it is opened by a YAG laser) and/or when the reabsorption of the reabsorbable membrane/cap 32 occurs at the level of the distal filtration hole 28, or the opening of at least one of the distal filtration holes 28 is made on the upper or upper-lateral surface 36 of the medical device 4 itself by the methods described above.

[0071] The opening of the filtration holes 24, 28 is made directly or occurs by reabsorption of the membrane 32 after a suitable number of days, so as to give the conjunctival wound time to heal and be sealed. The amount or volume of filtration is determined by the diameter and number of openings of the filtration holes 24, 28 on the extraocular segment.

[0072] As mentioned above, opening of the filtration holes 24, 28 may take place in various ways.

[0073] Opening of the filtration holes 24, 28 may take place by pressure with a metal stylet (or alternatively also of other materials) thereon so as to obtain yielding thereof towards the inside of the tubular body 8 according to a programmed, controlled and predetermined process. Each opening of a filtration hole 24, 28 causes a release of a predetermined quantity of microliters of aqueous humor/hour. Filtration holes 24, 28 may be opened also by treatment with an argon-type thermal laser or by a YAG laser. The material of the holes may be the same as the structure of the medical device 4 or different, according to the needs and opening methods.

[0074] The proximal hole 24 of the endocular ending is preferably closed by a membrane of resorbable material and therefore is not patent at the time of implantation. The closure material has the feature of being resorbable in about 1-15 days. Alternatively, the closure may be made with non-resorbable material but sensitive to treatment with a YAG laser which causes the destruction of the material itself and the consequent patency of the medical device 4.

[0075] Therefore, the implant does not determine any filtration in the immediate postoperative period (as in known solutions). This specific feature allows the surgery-induced conjunctival wound to heal before the flow of aqueous humor begins.

[0076] As can be seen from the above description, the medical device according to the present invention allows the drawbacks of the prior art to be overcome.

[0077] In particular, the present invention allows modulating the filtration in the postoperative period in a selective, progressive and controlled manner according to the intraocular pressure of the single patient.

[0078] Furthermore, the device allows solving the problem of abnormal filtration through the conjunctival suture in the immediate postoperative period.

[0079] Furthermore, the device allows solving the problem of abnormal filtration due to the fact that filtration is not immediate, but occurs only after the conjunctiva has healed correctly.

[0080] As described above, the suture of the scleral flap is made to be sealed. The aqueous humor does not filter through the scleral flap (as in the solutions of the prior art) but filters through the filtration holes outside the same. The unpredictability caused by surgeon's hands in placing the sutures of the flap is therefore eliminated. Therefore, in this case the scleral flap has only the protective function of the implanted device and no longer determines the quantity or volume of the aqueous humor flow (as occurs in the solutions of the prior art).

[0081] Furthermore, as seen, the positioning tabs allow both the suture of the implant to the sclera and their positioning in scleral pockets without the need for sutures.

[0082] A person skilled in the art may make several changes and adjustments to the medical devices described above in order to meet specific and incidental needs, all falling within the scope of protection .as described and claimed herein.