WO2019193435A1

WO2019193435A1 - Drainage wick implant for glaucoma patients

Info

Publication number: WO2019193435A1
Application number: PCT/IB2019/051797
Authority: WO
Inventors: Prakhyat ROOP
Original assignee: Prakhyat ROOP
Priority date: 2018-04-04
Filing date: 2019-03-06
Publication date: 2019-10-10

Abstract

Drainage wick implant for glaucoma patients. A drainage wick implant (100) for implanting in the eye (500) of glaucoma patients is provided. The drainage wick implant (100) comprises a first portion (102) defining a tip (112), wherein the tip (112) is such that at least a portion of the tip (112) is exposed to aqueous humour (516) in the eye (500), when the drainage wick implant (100) is implanted; a second portion (106) having a surface area larger than the first portion (102); and an intermediate portion (104) extending between the first portion (102) and the second portion (106). At least a part of, the first portion (102), the second portion (106) and the intermediate portion (104) enables capillary action, thereby enabling draining of aqueous humour (516) from the eye (500), through the first portion (102), the second portion (106) and the intermediate portion (104).

Description

DRAINAGE WICK IMPLANT FOR GLAUCOMA PATIENTS

BACKGROUND

[0001] Unless otherwise indicated herein, the materials described in this section are not prior art to the claims in this application and are not admitted to being prior art by inclusion in this section.

Field of the invention:

[0002] The subject matter in general relates to drainage implants for glaucoma patients. More particularly, but not exclusively, the subject matter relates to an improved glaucoma implant for effectively maintaining the required pressure in the eye.

Discussion of the related art:

[0003] In a healthy eye, a transparent fluid called aqueous humour is produced by the ciliary body in the front portion of the eye. The fluid flows out through a tiny drain called trabecular meshwork located between the outer rim of the iris and the back of the cornea. Pressure in the eye depends on a balance between the production of aqueous humour and its exit through the trabecular meshwork. In case the generated fluid does not flow out of the trabecular meshwork, it leads to an increase in the pressure, leading to a disorder called Glaucoma. This condition might result in the damage of optic nerve and eventually lead to irreversible loss of vision.

[0004] Several methods exist for the treatment of glaucoma, including drugs, non implant surgeries, and implant surgeries. Conventionally, drugs may be administered in the form of topical ophthalmic drops or orally administered medications that may reduce the production of aqueous humour or increase its outflow from the chamber of the eye. However, such therapies usually result in frequent side effects such as blurred vision, headache, allergic reactions and different drug interactions. Moreover, they are supposed to be used life-long. Similarly, non-implant surgeries such as Trabeculectomy may not give long lasting results and suffer from several drawbacks.

[0005] In view of the limitations of drugs-based treatment and non-implant surgeries, advanced methods like implant surgeries may be desired. Glaucoma implants are known to lower the pressure inside the eye by increasing the flow of the fluid out of the eye. Examples of conventional Glaucoma implants can be found in US patents 5397300, 6050970, 5882327, 5178604 and 5476445. Conventional implants include a drainage tube through which fluid drains out to the connected carrier plate. Such implants may suffer from various disadvantages, such as excess or under flow of fluid through the tube, blockage of the tube, inefficient functioning of valve (if any), and difficulty in the process of implanting, among others.

[0006] In light of the foregoing discussion, there is a need for an improved glaucoma implant.

SUMMARY

[0007] In one aspect, a drainage wick implant for glaucoma patients is provided. The drainage wick implant comprises a first portion, a second portion and an intermediate portion. The first portion defines a tip, wherein the tip is such that at least a portion of the tip is exposed to aqueous humour in the eye, when the drainage implant is implanted. The second portion has a surface area larger than the first portion and an intermediate portion extends between the first portion and the second portion. The first portion is present towards an anterior side of the drainage implant, whereas the second portion is towards a posterior side of the drainage implant, relative to the cornea, when implanted. At least a part of, the first portion, the second portion and the intermediate portion enables capillary action, thereby enabling draining of aqueous humour from the eye.

BRIEF DESCRIPTION OF DRAWINGS

[0008] Embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which:

[0009] FIG. 1A illustrates a drainage wick implant 100 for implanting in the eye of glaucoma patients.

[0010] FIG. 1B illustrates a first portion 102 of the drainage wick implant 100 comprising a width W 1 and a height Hl .

[0011] FIG. 1C illustrates an intermediate portion 104 of the drainage wick implant 100 comprising a width W2 and a height H2.

[0012] FIG. 1D illustrates a second portion 106 of the drainage wick implant 100 comprising a width W3 and a height H3.

[0013] FIG. 2 illustrates the drainage wick implant 100 with a thickness T

[0014] FIG. 3A-3D illustrates alternate embodiments of the drainage wick implant 100 with different shapes.

[0015] FIG. 4A illustrates the drainage wick implant 400 made using a combination of biodegradable material 402 and non-biodegradable material 404. [0016] FIG. 4B illustrates the drainage wick implant 400 along a longitudinal axis AA.

[0017] FIG. 4C illustrates the cross-sectional view of drainage wick implant 400 along the longitudinal axis AA.

[0018] FIG. 4D illustrates the drainage wick implant 400 along a horizontal axis BB.

[0019] FIG. 4E illustrates the cross-sectional view of drainage wick implant 400 along the horizontal axis BB.

[0020] FIG. 5A-5B provides simplified illustration of the eye 500 after implantation of the drainage wick implant 100 at upper and lower portions of the eye 500, respectively.

[0021] FIG. 6 illustrates an enlarged view of the eye 500 after implantation of the drainage wick implant 100 at upper portions of the eye 500.

[0022] FIG. 7A-7D illustrates simplified sequence of steps involved in the implantation of the drainage wick implant 100.

DETAILED DESCRIPTION

[0023] The following detailed description includes references to the accompanying drawings, which form part of the detailed description. The drawings show illustrations in accordance with example embodiments. These example embodiments are described in enough details to enable those skilled in the art to practice the present subject matter. However, it may be apparent to one with ordinary skill in the art that the present invention may be practised without these specific details. In other instances, well-known methods, procedures and components have not been described in detail so as not to unnecessarily obscure aspects of the embodiments. The embodiments can be combined, other embodiments can be utilized or structural and logical changes can be made without departing from the scope of the invention. The following detailed description is, therefore, not to be taken as a limiting sense.

[0024] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one. In this document, the term“or” is used to refer to a non-exclusive“or”, such that“A or B” includes“A but not B”,“B but not A”, and“A and B”, unless otherwise indicated.

OVERVIEW

[0025] Embodiments disclose improved drainage wick implant for glaucoma patients. The implant lowers the pressure inside the eye by increasing the flow of aqueous humour out of the eye. The drainage wick implant comprises a first portion that defines a tip, a second portion having a larger surface area than the first portion and an intermediate portion that extends between the first and the second portions. The drainage wick implant is implanted into the eye, such that, the first portion is towards an anterior side and the second portion is towards posterior side, relative to the cornea. The fluid is drained out of the eye through capillary action of the different portions of the drainage wick implant. The drainage wick implant is inserted in the eye in such a way that the first portion defining a tip is inserted into the anterior chamber of the eye and the second portion is placed on the surface of bare sclera.

CONSTRUCTION OF DRAINAGE IMPLANT

[0026] Referring to the figures, and more particularly to FIG. 1 A, a drainage wick implant 100 is provided for implanting in the eye of glaucoma patients. The drainage wick implant 100 may be made of a porous material that comprises a first portion 102, a second portion 106 having a larger surface area than the first portion 102 and an intermediate portion 104 that extends between the first 102 and the second portions 106.

[0027] As disclosed in FIG. 1B, the first portion 102 of the drainage wick implant 100 defines a tip 112 at one end and defines a base edge 114 (although edge as such is absent since intermediate portion extends from the base of the first portion 114) at the other end.

[0028] In an embodiment, width Wl of the base edge 114 is between 1 mm and 4 mm along a horizontal axis 108 of the drainage wick implant 100.

[0029] In a preferred embodiment, the width Wl of the base edge 114 is about 2.5mm.

[0030] In an embodiment, first portion 102 extends to a height Hl between 0.5 mm and 3 mm, wherein the height Hl is along a longitudinal axis 110 of the drainage wick implant 100.

[0031] In a preferred embodiment, the height Hl of the first portion 102 is about l.5mm.

[0032] When implanted in the eye, the tip 112 of the first portion 102 is positioned towards an anterior side, relative to the cornea. The first portion 102 has a smaller surface area than the second portion 106, such that the first portion 102 is enabled to drain the aqueous humour 516 from the front portion of the eye 500. In an embodiment, the first portion 102 has a triangular structure.

[0033] FIG. 1D discloses the second portion 106 of the drainage wick implant 100, which has a larger surface area than the first portion 102.

[0034] In an embodiment, width W3 of the second portion 106 along a horizontal axis 108 is between 4 mm and 20 mm.

[0035] In a preferred embodiment, the width W3 of the second portion 106 is about 10 mm . [0036] In an embodiment, second portion 106 extends to a height H3 along a longitudinal axis 110 between 2 mm and 12 mm.

[0037] In a preferred embodiment, the height H3 of the second portion is about 6 mm.

[0038] When implanted in the eye, the second portion 106 is positioned towards a posterior side, relative to the cornea.

[0039] In an embodiment, the second portion 106 has a circular or oblong structure.

[0040] With reference to FIG. 1C, the intermediate portion 104 of the drainage wick implant 100 extends between the first portion 102 and the second portion 106. The intermediate portion 104 extends from the base edge 114 of the first portion 102.

[0041] In an embodiment, the width W2 of the intermediate portion 104 is between 0.5 mm and 3 mm, wherein the width W2 is along a horizontal axis 108.

[0042] In a preferred embodiment, the width W2 of the intermediate portion 104 is about 1.5 mm.

[0043] In an embodiment, the height H2 of the intermediate portion 104 along a longitudinal axis 110 is between 0.5 mm and 20 mm.

[0044] In a preferred embodiment, the height H2 of the intermediate portion 104 is about 1.5 mm.

[0045] In an embodiment, the horizontal axis 108 is perpendicular to a longitudinal axis 110, wherein the longitudinal axis 110 passes through the first portion 102, the second portion 106 and the intermediate portion 104 of the drainage wick implant 100.

[0046] In an embodiment, the drainage wick implant 100 has a thickness T, wherein the thickness T is between 0.5 mm and 2 mm.

[0047] In a preferred embodiment, the thickness T of the drainage wick implant 100 is about 1 mm (refer FIG. 2).

[0048] In an embodiment, the porous nature of the first portion 102, the second portion 106 and the intermediate portion 104 enables capillary action, thereby enabling the aqueous humour 516 present in the front portion of the eye 500 to be drained out.

[0049] In an embodiment, at least a part of the first portion 102, the second portion 106 and the intermediate portion 104 enables capillary action. The aqueous humour 516 is initially absorbed into to the first portion 102 through the tip 112, further moves along the intermediate portion 104 and eventually into the second portion 106. This capillary action enables a steady flow of the fluid 516 to drain out, thereby regulating the pressure inside the eye.

[0050] The drainage wick implant 100 may be shaped to conform to the curvature of the eye 500. FIG. 3A-3D discloses different example embodiments of the drainage wick implant 100 with varied shapes and dimensions of the first portion 102, the second portion 106 and the intermediate portion 104.

[0051] FIG. 3 A discloses an example embodiment of the drainage wick implant 100 wherein the second portion 106 has a semi-circular shape. The first portion 102 has shorter height in comparison with second portion 106 and intermediate portion 104. The width Wl of the base edge 114 of the first portion 102 may be equal to the width W2 of the intermediate portion 104.

[0052] FIG. 3B discloses another example embodiment of the drainage wick implant 100 wherein the second portion 106 has a rectangular shape with blunt corners. The width Wl of the base edge 114 of the first portion 102 is larger than the width W2 of the intermediate portion 104.

[0053] FIG. 3C discloses yet another example embodiment of the drainage wick implant 100 wherein the second portion 106 has an ovoid shape. The width W2 of the intermediate portion 104 and width Wl of the first portion 102 gets narrow towards the tip 112 of the first portion 102. Moreover, the two halves of the first portion 102 along the longitudinal axis 112 are symmetrical.

[0054] FIG. 3D discloses yet another example embodiment of the drainage wick implant 100 wherein the second portion 106 has a triangular shape with blunt corners. The two halves of the first portion 102 along the longitudinal axis 112 are not symmetrical wherein margin of one half is parallel to the longitudinal axis 112 whereas the margin of another half is curved.

[0055] In an embodiment, the drainage wick implant 100 is made using biodegradable materials. In an embodiment, the biodegradable materials are selected from the group consisting of silk, collagen, gelatin, fibrinogen, elastin, keratin, albumin, chitosan, hyaluronic acid, Polyvinylpyrrolidone, Poly actide, Polyglycolide, Poly(l-lactide-co-glycolide), Polyalkylcyanoacrylate, Poly caprolactone, Poly ethylene oxide, polypropylene, polyanhydrides, Polylactic Acid, Polyglycolic Acid and Polylactic-Glycolic acid, Calcium alginate and the combinations thereof.

[0056] In another embodiment, the drainage wick implant 100 is made using non- biodegradable materials. In an embodiment, the non-biodegradable materials are selected from the group consisting of Polyethylene (PE) (HDPE, EIHMWPE), Polypropylene (PP), Polytetrafluroethylene (PTFE), extended-PTFE, Polymethymethacrylate, Ethylene-co- vinylacetate (EVA), Polydimethylsiloxane (PDMS), Polyether-urethanes (PU), Polyethylene terphthalate (PET), Polysulphone (PS), Polyethyleneoxide, (PEO, PEG), Polyethyleneoxide- copropyleneoxide, Polyvinylalcohol and the combinations thereof.

[0057] FIG. 4A discloses yet another embodiment, wherein the drainage wick implant 400 may be made using a combination of biodegradable 402 and non-biodegradable materials 404.

[0058] In an embodiment, a portion of the drainage wick implant 100 is made up of the biodegradable material 402 and another portion made of non-biodegradable material 404. Such drainage wick implant 100 may continue to function over an extended period of time after implantation. Though the biodegradable material 402 gets degraded over a period, the drainage wick implant 100 continue to function with the non-biodegradable materials 404.

[0059] In an embodiment, sections of one or more of the first portion 102, the second portion 106 and the intermediate portion 104 are made of bio-degradable material 402.

[0060] In an embodiment, sections of one or more of the first portion 102, the second portion 106 and the intermediate portion 104 are made of non-biodegradable material 404.

[0061] FIG. 4B discloses the drainage implant 400 along a longitudinal axis AA. FIG. 4D discloses the cross-sectional view of the drainage implant 400 along the longitudinal axis AA. In an embodiment, selected layers of one or more of the first portion 102, the second portion 106 and the intermediate portion 104 are made of bio-degradable material 402.

[0062] In an embodiment, selected layers of one or more of the first portion 102, the second portion 106 and the intermediate portion 104 are made of non-biodegradable material 404.

[0063] FIG. 4C discloses the drainage implant 400 along a horizontal axis BB. FIG. 4E discloses the cross-sectional view of the drainage implant 400 along a horizontal axis BB. In an embodiment, selected strands of one or more of the first portion 102, the second portion 106 and the intermediate portion 104 are made of bio-degradable material 402.

[0064] In an embodiment, selected strands of one or more of the first portion 102, the second portion 106 and the intermediate portion 104 are made of non-biodegradable material 404.

[0065] In an embodiment, a skeletal framework of one or more of the first portion 102, the second portion 106 and the intermediate portion 104 are made of non-biodegradable material 404, while at least a part of the rest of the portions of one or more of the first portion 102, the second portion 106 and the intermediate portion 104 are made of biodegradable material 402.

[0066] In an embodiment, at least one drug is impregnated in the drainage wick implant 100 [0067] In an embodiment, at least a portion of the drainage implant 100 is porous. The porosity is varied to achieve target intraocular pressure. Higher porosity achieves less target intraocular pressure, whereas lower porosity achieves more target intraocular pressure.

TECHNIQUE OF IMPLANTING THE DRAINAGE IMPLANT

[0068] The drainage wick implant 100 is implanted into the eye 500 of glaucoma patients using ophthalmic surgical techniques. FIG. 7A-7D discloses simplified sequence of steps for implanting the drainage wick implant 100 into the eye 500. With reference to FIG. 7B, a incision is made in the conjunctiva 502 so that a fornix based conjunctival flap 510 is lifted. A partial thickness scleral tunnel 512 is made from posterior to the limbus 508 up to clear cornea 506. The edge of the scleral tunnel 512 is lifted and part of base of the tunnel 512 is excised at limbus 508. A peripheral iridectomy is made if required. As disclosed in FIG. 7C and 7D, the first portion 102 of the drainage wick implant 100 is inserted into the anterior chamber 514 of the eye 500 and second portion 106 is placed on the surface of bare sclera 504.

[0069] In an embodiment, the scleral tunnel 512 may be stitched on either side of the intermediate portion 104 of the drainage wick implant 100 to keep the implant 100 stable at its place.

[0070] In another embodiment, the scleral tunnel 512 may be left un-stitched.

[0071] The drainage wick implant 100 may be implanted either at the upper portion, lower portion or in any other meridian of the eye 500. FIG. 5A discloses the cross-sectional view of the eye 500 with the drainage wick implant 100 implanted at the upper portion of the eye 500, whereas FIG. 5B discloses the cross-sectional view of the eye 500 with the drainage wick implant 100 implanted at the lower portion of the eye 500. FIG. 6 illustrates an enlarged view of the eye 500 after implantation of the drainage wick implant 100 at upper portions of the eye 500.

[0072] The processes described above is described as a sequence of steps, this was done solely for the sake of illustration. Accordingly, it is contemplated that some steps may be added, some steps may be omitted, the order of the steps may be re-arranged, or some steps may be performed simultaneously.

[0073] Although embodiments have been described with reference to specific example embodiments, it will be evident that various modifications and changes may be made to these embodiments without departing from the broader spirit and scope of the system and method described herein. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense.

[0074] Many alterations and modifications of the present invention will no doubt become apparent to a person of ordinary skill in the art after having read the foregoing description. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. It is to be understood that the description above contains many specifications, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the personally preferred embodiments of this invention.

Claims

CLAIMS I claim,

1. A drainage wick implant (100) for glaucoma patients, the drainage wick implant (100) comprising:

a first portion (102) defining a tip (112), wherein the tip (112) is such that at least a portion of the tip (112) is exposed to aqueous humour (516) in the eye (500), when the drainage wick implant (100) is implanted;

a second portion (106) having a surface area larger than the first portion (102); and an intermediate portion (104) extending between the first portion (102) and the second portion (106);

wherein,

the first portion (102) is towards an anterior side of the drainage wick implant (100), relative to the cornea (506), when implanted; the second portion (106) is towards a posterior side of the drainage wick implant (100), relative to the cornea (506), when implanted; and at least a part of, the first portion (102), the second portion (106) and the intermediate portion (104) enables capillary action, thereby enabling draining of aqueous humour (516) from the eye (500), through the first portion (102), the second portion (106) and the intermediate portion (104).

2. The drainage wick implant (100) of claim 1, wherein the first portion (102) comprises a base edge (114), wherein the intermediate portion (104) extends from the base edge (114), wherein the width (W 1) of the base edge (114) is between 1 mm and 4 mm.

3. The drainage wick implant (100) of claim 2, wherein the width (Wl) of the base edge is about 2.5 mm.

4. The drainage wick implant (100) of claim 1, wherein a height (Hl) of the first portion (102) is between 0.5 mm and 3 mm, wherein the height (Hl) is along a longitudinal axis (110) of the drainage wick implant (100), wherein the longitudinal axis (110) passes through the first portion (102), the second portion (106) and the intermediate portion (104).

5. The drainage wick implant (100) of claim 4, wherein the height (Hl) of the first portion (102) is about l.5mm.

6. The drainage wick implant (100) of claim 1, wherein width (W3) of the second portion (106) is between 4 mm and 20 mm, wherein the width (W3) is along a horizontal axis (108), wherein the horizontal axis (108) is perpendicular to a longitudinal axis (110), wherein the longitudinal axis (110) passes through the first portion (102), the second portion (106) and the intermediate portion (104).

7. The drainage wick implant (100) of claim 6, wherein the width (W3) of the second portion (106) is about 10 mm.

8. The drainage wick implant (100) of claim 1, wherein a height (H3) of the second portion (106) is between 2 mm and 12 mm, wherein the height (H3) is along a longitudinal axis (110) of the drainage wick implant (100), wherein the longitudinal axis (110) passes through the first portion (102), the second portion (106) and the intermediate portion (104).

9. The drainage wick implant (100) of claim 8, wherein a height (H3) of the second portion (106) is about 6 mm.

10. The drainage wick implant (100) of claim 1, wherein width (W2) of the intermediate portion (104) is between 0.5 mm and 3 mm, wherein the width (W2) is along a horizontal axis (108), wherein the horizontal axis (108) is perpendicular to a longitudinal axis (110), wherein the longitudinal axis (110) passes through the first portion (102), the second portion (106) and the intermediate portion (104).

11. The drainage wick implant (100) of claim 10, wherein the width (W2) of the intermediate portion (104) is about 1.5 mm.

12. The drainage wick implant (100) of claim 1, wherein a height (H2) of the intermediate portion (104) is between 0.5 mm and 20 mm, wherein the height (H2) is along a longitudinal axis (110) of the drainage wick implant (100), wherein the longitudinal axis (110) passes through the first portion (102), the second portion (106) and the intermediate portion (104).

13. The drainage wick implant (100) of claim 12, wherein the height (H2) of the intermediate portion (104) is about 1.5 mm.

14. The drainage wick implant (100) of claim 1, wherein the drainage wick implant (100) has a thickness (T), wherein the thickness (T) is between 0.5 mm and 2 mm.

15. The drainage wick implant (100) of claim 14, wherein the thickness (T) of the drainage wick implant (100) is about 1 mm.

16. The drainage wick implant (100) of claim 1, wherein the drainage wick implant (100) is made of a combination of biodegradable (402) and non-biodegradable material (404).

17. The drainage wick implant (100) of claim 16, wherein sections of one or more of the first portion (102), the second portion (106) and the intermediate portion (104) are made of bio-degradable material (402).

18. The drainage wick implant (100) of claim 16, wherein sections of one or more of the first portion (102), the second portion (106) and the intermediate portion (104) are made of non-biodegradable material (404).

19. The drainage wick implant (100) of claim 16, wherein selected layers of one or more of the first portion (102), the second portion (106) and the intermediate portion (104) are made of bio-degradable material (402).

20. The drainage wick implant (100) of claim 16, wherein selected layers of one or more of the first portion (102), the second portion (106) and the intermediate portion (104) are made of non-biodegradable material (404).

21. The drainage wick implant (100) of claim 16, wherein selected strands of one or more of the first portion (102), the second portion (106) and the intermediate portion (104) are made of bio-degradable material (402).

22. The drainage wick implant (100) of claim 16, wherein selected strands of one or more of the first portion (102), the second portion (106) and the intermediate portion (104) are made of non-biodegradable material (404).

23. The drainage wick implant (100) of claim 16, wherein a portion of the drainage wick implant (100) made of the biodegradable material (402) is arranged with a framework of the drainage wick implant (100), wherein the framework is made of the non-biodegradable material (404).

24. The drainage wick implant (100) of claim 23, wherein at least a part of the rest of the portions of one or more of the first portion (102), the second portion (106) and the intermediate portion (104) are made of biodegradable material (402).

25. The drainage wick implant (100) of claim 1, wherein the first portion (102) has a triangular structure.

26. The drainage wick implant (100) of claim 1, wherein the second portion (106) has a circular or oblong structure.

27. The drainage wick implant (100) of claim 1, wherein at least one drug is impregnated in the drainage wick implant (100).

28. The drainage implant (100) of claim 1, wherein at least a portion of the drainage implant (100) is porous, wherein the porosity is varied to achieve target intraocular pressure, wherein higher porosity achieves less target intraocular pressure and lower porosity achieves more target intraocular pressure.