CANALICULAR PLUG, METHOD AND KIT FOR TREATING DRY EYE

Abstract

A plug for occluding an ocular canaliculus comprises a cylindrical body member having a first outer diameter. The cylindrical body member is provided along an external surface with at least one outwardly extending projection having a second outer diameter greater than the first outer diameter and larger than an inner diameter of an ocular canaliculus. The first outer diameter of the plug is typically less than and approximately equal to the inner diameter of the canaliculus.

Claims

1. A plug for occluding an ocular canaliculus, comprising a cylindrical body member, said cylindrical body member having a first outer diameter, said cylindrical body member being provided along an external surface with at least one projection extending outwardly to a second outer diameter greater than said first outer diameter, said second outer diameter being greater than an inner diameter of the ocular canaliculus.

2. The plug defined in claim 1 wherein said projection is an annular rib.

3. The plug defined in claim 2 wherein said projection is one of a plurality of annular ribs provided along an external surface of said cylindrical body member, all of said annular ribs being coaxial with an axis of said cylindrical body member.

4. The plug defined in claim 2 wherein said annular rib has a smoothly arcuate outer surface.

5. The plug defined in claim 2 wherein said annular rib has a cross-section with a substantially semi-circular outer periphery.

6. The plug defined in claim 1 wherein said cylindrical body is provided on at least one end with a formation taken from the group of a recess and an additional projection extending axially from said cylindrical body member.

7. The plug defined in claim 6 wherein said recess is a slot and said additional projection is a planar or plate-shaped extension of said cylindrical body member.

8. The plug defined in claim 1 wherein said first outer diameter is less than said inner diameter of said ocular canaliculus.

9. A kit for use in treating dry eye syndrome, comprising: a container; and a plurality of plugs disposed in said container, each of said plugs having a cross-section accommodating insertion of the respective plug in an ocular canaliculus of a human patient, at least a first one of said plugs having a first length, at least a second one of said plugs having a second length a first fraction of said first length, at least a third one of said plugs having a third length a second fraction of said first length.

10. The kit defined in claim 9 wherein each of said plugs includes a cylindrical body member, said cylindrical body member having a first outer diameter, said cylindrical body member being provided along an external surface with at least one projection extending outwardly to a second outer diameter greater than said first outer diameter and larger than an inner diameter of the canaliculus of the patient.

11. The kit defined in claim 10 wherein said projection is an annular rib.

12. The kit defined in claim 11 wherein said projection is one of a plurality of annular ribs provided along an external surface of said cylindrical body member, all of said annular ribs being coaxial with an axis of said cylindrical body member.

13. The kit defined in claim 10 wherein said first outer diameter is less than said inner diameter of said canaliculus.

14. The kit defined in claim 9 wherein each of said plugs is provided on at least one end with a formation taken from the group of a recess and a projection extending axially from the respective cylindrical body member.

15. The kit defined in claim 14 wherein said recess is a slot and said projection is a planar or plate-shaped extension of the respective plug.

16. The kit defined in claim 9 further comprising an insertion tool configured for rotating a deployed plug that is disposed in an ocular canaliculus.

17. The kit defined in claim 16 wherein said tool includes a distal tip with a geometric configuration that is rotatively lockable to and removable from said deployed plug.

18. The kit defined in claim 9 wherein said first fraction is about one half and said second fraction is about one quarter.

19. A method for treating dry eye syndrome, comprising: (a) inserting a first canalicular plug into an upper canaliculus of a patient's eye, said first canalicular plug having a first length; (b) carrying out a testing or calibration process to determine an optimal length of a second canalicular plug for a lower canaliculus of the patient's eye, said testing or calibration process including (i) inserting a first test or calibration plug into a lower canaliculus of the patient's eye, said first test or calibration plug having a second length, (ii) after a first testing period of predetermined duration during which tear accumulation in the patient's eye is monitored, inserting a second test or calibration plug into the lower canaliculus of the patient's eye and adjacent said first test or calibration plug, (iii) optionally repeating steps (i) and (ii) using additional test or calibration plugs of respective lengths, and (c) after a determination that tear accumulation in the patient's eye is satisfactory, inserting a long-term or extended-wear canalicular plug of said optimal length into the lower canaliculus of the patient's eye, said optimal length being a total length that is at least approximately equal to a sum of the lengths of a set of the test or calibration plugs disposed in the lower canaliculus of the patient's eye upon termination of said testing or calibration process.

20. The method defined in claim 19 wherein the inserting of said second test or calibration plug includes rotatively locking said second test or calibration plug and said first test or calibration plug to one another by engaging cooperating elements on adjacent ends of said first test or calibration plug and said second test or calibration plug with one another.

21. (canceled)

22. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 is a schematic side elevational view of a canalicular plug for deployment in the canaliculus of a patient suffering dry eye syndrome.

[0027] FIG. 2 is a schematic right side elevational view of the canalicular plug of FIG. 1. FIG. 3 is a schematic left side elevational view of the canalicular plug of FIG. 1.

[0028] FIG. 4 is a schematic longitudinal cross-sectional view taken along line IV-IV in FIG. 2. FIG. 5 is a schematic side elevational view of a smaller or shorter canalicular plug for deployment in a canaliculus of a patient suffering dry eye syndrome, for use in a titrating or customizing process to determine an optimal plug size.

[0029] FIG. 6 a schematic longitudinal cross-sectional view taken parallel to the plane of the drawing in FIG. 5.

[0030] FIG. 7 is a schematic side elevational view of an even smaller or shorter canalicular plug for deployment in a canaliculus of a patient suffering dry eye syndrome, for use in a titrating or customizing process to determine an optimal plug size.

[0031] FIG. 8 a schematic longitudinal cross-sectional view taken parallel to the plane of the drawing in FIG. 7.

[0032] FIG. 9 is a schematic representation of a kit for treating dry eye symptoms.

[0033] FIG. 10 is a diagrammatic partial end elevational view, on an enlarged scale, of an ocular plug with a slot and undercuts for facilitating insertion.

DETAILED DESCRIPTION

[0034] As illustrated in FIGS. 1-4, a plug 20 for occluding a canaliculus comprises a cylindrical body member 22 having a first outer diameter d1. Cylindrical body member 22 is provided along an external surface 24 with at least one outwardly extending projection 26 having a second outer diameter d2 that is greater than diameter d1 and larger than an inner diameter of an ocular canaliculus. Preferably outer diameter d1 is less than and approximately equal to the inner diameter of the ocular canaliculus or canalicular duct.

[0035] Canalicular plug 20 may serve as a long-term or extended-wear plug, which once implanted remains in the canaliculus for months at a time. In that case plug 20 may be longer, with three or more outwardly extending projections 26. Alternatively, plug 20 may serve as a titrating or customizing plug for use in a method to determine an optimal length of an extended wear canalicular plug. Typically, an upper canaliculus of a patient is fitted with a standard size long-term plug (or one of a plurality of standard size plugs) that substantially completely occludes the upper canaliculus, while a testing or calibration process is used on the associated lower canaliculus to determine a plug length that effectively reduces dry eye symptoms but does not lead to epiphora.

[0036] Projection 26 preferably takes the form of an annular rib having a smoothly arcuate outer surface, that is, without points or sharp edges. Rib 26 has, for instance, a cross-section with an outer boundary that is a section of a circle. Where plug 20 has an extended length, multiple annular ribs 26 may be axially staggered along external surface 24 of the plug. Ribs 26 are typically coaxial with an axis 28 of cylindrical body member 22.

[0037] Cylindrical body member 22 of plug 20 may be provided on at least one end with a formation facilitating insertion of the plug into a canaliculus. If the plug is a test or calibration plug, the formation also serves to rotationally lock the plug to an adjacent plug during the testing process. As illustrated in FIGS. 1-4, a test or calibration plug 20 may include a first formation in the form of a slot-shaped recess 30 at one end and a second formation in the form of a plate-shaped projection 32 at an opposite end. Recess 30 and projection 32 are symmetric about axis 28 and modularly sized: projection 32 is slightly smaller than recess 30 and geometrically similar thereto so that a projection 32 on one canalicular plug of a set of plugs can insert into the recess 30 of another plug. Recesses 30 and projections 32 thus mate with one another to thereby prevent relative rotation of two adjacent plugs once the same are properly deployed in a canaliculus (usually a lower duct) of a patient, typically in a testing or calibration process.

[0038] As illustrated in FIGS. 5 and 6, an intermediately sized plug 40 for partially occluding a lacrimal duct or canaliculus in a testing or measurement process together with one or more additional test or calibration plugs comprises a cylindrical body member 42 having a first outer diameter d1′. Cylindrical body member 42 is provided along an external surface 44 with two outwardly extending projections 46a and 46b each having a second outer diameter d2′ that is greater than diameter d1′ and larger than an inner diameter of an ocular canaliculus or lacrimal duct. Preferably outer diameter d1′ is less than and approximately equal to the inner diameter of the ocular canaliculus or lacrimal duct (typically a lower canaliculus) being fitted for a long-term plug.

[0039] Projections 46a and 46b are preferably each in the form of an annular rib having a smoothly arcuate outer surface, that is, without points or sharp edges at least along the outermost regions that come into contact with the inner surface of the canaliculus. Ribs 46a has, for instance, a cross-section with an outer boundary that is a section of a circle. Rib 46b is truncated. While rib 46b has a sharp terminal edge 47, the edge preferably has a diameter sufficiently smaller than diameter d2′ to avoid undue irritation of the lacrimal duct. Alternatively, edge 47 may be blunted or rounded during the manufacturing process. Ribs 46a and 46b are coaxial with an axis 48 of cylindrical body member 42.

[0040] Cylindrical body member 42 of plug 40 is provided on one end with a first formation in the form of a slot-shaped recess 50 and on an opposite end with a second formation in the form of a plate-shaped projection 52. Recess 50 and projection 52 are symmetric about axis 48 and modularly sized: projection 52 is slightly smaller than recess 30 and geometrically similar thereto so that projection 52 can insert into recess 30 of a prior inserted test plug 20. Alternatively, projection 32 may face outwardly upon a seating of test plug 20 in a patient's canaliculus and be received in slot 50 of a subsequently inserted test plug 40. Recesses 30, 50 and projections 32, 52 are thus modularly designed to mate with one another to thereby prevent relative rotation of two adjacent test or calibration plugs 20, 40 once the same are properly deployed in a canaliculus (usually a lower duct) of a patient, typically in a testing or calibration process. This rotational locking serves in part to prevent drifting of the separate titrating or calibration plugs during the testing period and also during an extended wear period thereafter.

[0041] Canalicular plug 40 serves as a testing or calibration plug for use together with other titrating plugs such as test or calibration plug 20 in a method to determine an optimal length of a long-term or extended wear canalicular plug typically for a lower canaliculus of a patient. Typically, in such a method outer diameters d1′ and d2′ of plug 40 are respectively equal to outer diameters d1 and d2 of plug 20. Canalicular test plug 20 is inserted into the lower canaliculus of a patient, before or after the insertion of a longer plug (with a greater number of annular ribs 26) into the associated upper canaliculus. The patient wears the two plugs for a predetermined period of time, typically two or three weeks, and then provides a report on the effectiveness of the occlusion of the canaliculi. If the dry eye symptoms persist, test or calibration plug 40 is then inserted into the lower canaliculus of the patient adjacent plug 20 with projection 52 of plug 40 inserted into recess 30 of plug 20. During a subsequent monitoring period of pre-established duration, typically two to three weeks, the patient wears the two plugs 20 and 40 in the lower canaliculus and thereafter reports on eye dryness to the doctor. If the dry eye symptoms are obviated, without epiphora, then the test plugs 20 and 40 are typically retained in the lower canaliculus for an extended-wear period of up to 5-6 months. In subsequent treatments, single extended-wear plugs are inserted into the lower canaliculus, where the extended-wear plugs have a length equal to the sum of the lengths of the plugs 20, 40 that remain in the patient after the test period. If the test or calibration phase ends with the patient experiencing epiphora, then the subsequent extended-wear plugs selected may have a length somewhat shorter than the combined lengths of the inserted or deployed test plugs.

[0042] Although not necessary or advisable, the titrating or test plugs may be removed at the end of the test or calibration phase and the patient provided in the lower canaliculus with a long-term plug of a length about equal to the combined lengths of the test plugs 20 and 40. If the dry eye symptoms persist with plugs 20 and 40 disposed in the lower canaliculus, another test or calibration plug 60 (FIGS. 7 and 8) may then be inserted into the lower canaliculus of the patient over plugs 20 and 40 so that the test plugs 60 and 40 are adjacent to one another.

[0043] As illustrated in FIGS. 7 and 8, test plug 60 comprises a cylindrical body member 62 having a first outer diameter d1″. Cylindrical body member 62 is provided along an external surface 64 with one outwardly extending projection 66 having a second outer diameter d2″ that is greater than diameter d1″ and larger than an inner diameter of an ocular canaliculus. Preferably outer diameter d1″ is less than and approximately equal to the inner diameter of the ocular canaliculus (typically a lower canaliculus) being fitted for a long-term plug.

[0044] Projection 66 is preferably an annular rib having a smoothly arcuate outer surface, that is, without points or sharp edges at least along the outermost regions that come into contact with the inner surface of the canaliculus. Rib 66 has, for instance, a cross-section with an outer boundary that is a section of a circle. Rib 66 is coaxial with an axis 68 of cylindrical body member 62.

[0045] Cylindrical body member 62 of plug 60 is provided on one end with a first formation in the form of a slot-shaped recess 70 and on an opposite end with a second formation in the form of a plate-shaped projection 72. Recess 70 and projection 72 are symmetric about axis 68 and modularly sized: projection 72 has a size and shape selected to enable insertion of projection 72 into recess 30 or 50 of a prior inserted test plug 20 or 40. Alternatively, if projection 32 or 52 faces outwardly upon a seating of test plug 20 or 40 in a patient's canaliculus, projection 32 or 52 is received in slot 70 of subsequently inserted test plug 70. Thus, all recesses 30, 50, 70 and projections 32, 52, 72 are modularly adapted to mate with one another, which serves in part to prevent relative rotation of two adjacent test or calibration plugs 20, 40, 60 once the same are properly deployed in a canaliculus (usually a lower duct) of a patient, typically in a testing or calibration process. The rotational locking serves to hold the test or calibration plugs 20, 40, 60 in place relative to one another.

[0046] In summary, a method for treating dry eye syndrome contemplates the insertion of a long-term or extended-wear plug in one canaliculus (usually an upper) and the fitting of the other canaliculus (lower, usually) by testing the effectiveness of a series of test plug sets each having a respective combined or total plug length. In a typical procedure, the lower canaliculus of a patient is fitted with a series of test plug sets each incrementally longer than a prior test plug set. Should any particular set of deployed test plugs result in continued dry eye symptoms, then any long-term or extended-wear plug selected for the patient will be longer than the total plug length of the particular test set. Should any particular set of test plugs result in undue epiphora, then long-term or extended-wear plugs selected for the patient may be shorter than the total length of the test plugs of that test set.

[0047] As depicted in FIG. 9, a kit 80 for use in treating dry eye syndrome comprises a container 82 and a plurality of plugs 84 disposed in the container, each of the plugs having a cross-section accommodating insertion of the respective plug in a canaliculus of a human patient. At least one plug 86 in the kit has a first length s1, at least a second plug 88 has a second length s2 which is a fraction of the first length s1, and at least a third plug 90 has a third length s3 which is a different fraction of the first length s1. The second and third plugs 88 and 90 may have a common length (s2=s3), for instance, a third or a quarter of the length s1 of the first plug 86. Preferably, the second and third plugs 88 and 90 are of different lengths, for instance, one a half and the other a quarter of the lengths of the first plug 86. As described above, plugs 86, 88, and 90 are test or calibration plugs of staggered sizes adapted for a step wise titration or customization process wherein the total length of several plugs placed in a canaliculus (typically the lower of the two ducts for a given eye) is incrementally increased over a period of several weeks to a few months to determine an optimal plug length for the patient. At the end of the testing or calibration period, the final set of customization or testing plugs is typically allowed to remain in the patient's lower canaliculus and subsequently, after dissolution of the test plugs, a long-term plug is inserted having a length equal to the sum of the lengths of the test plugs determined as optimal for treating dry eye symptoms of the patient. The long-term plug may be cut from a plug blank 92 that has a predetermined standard maximum length. Preferably, kit 80 includes a set of long-term canalicular plugs 94 of different predetermined lengths each equal to a composite length of a respective set of the test or calibration plugs 84. One of the long-wear canalicular plugs 94 is selected for insertion into the lower canaliculus after determination of an optimal length for treating dry eye symptoms without inducing epiphora.

[0048] Kit 80 may additionally include one or more long-wear canalicular plugs 96 of predetermined dimensions for completely occluding the upper canaliculus of the eye being treated. Typically, plugs 96 have a length sufficiently large to ensure complete occlusion of the upper canaliculus.

[0049] Kit 80 may further include one or more additional sets of test or calibration plugs 98 of staggered lengths which have a larger base diameter d3, annular sealing rings or projections 100 of larger outer diameters d4, and a different selection of lengths.

[0050] Each of the plugs 86, 88, 90, 92, 94, 96, 98 in kit 80 includes, as discussed above with reference to FIGS. 1-8, a cylindrical body member having a base outer diameter less than and approximately equal to an inner diameter of an ocular canaliculus. Each plug 86, 88, 90, 92, 94, 96, 98 is formed along an external surface of the respective cylindrical body member with at least one outwardly extending preferably annular projection having an outer diameter greater than the base diameter of the cylindrical body member and larger than the inner diameter of the canaliculus. As discussed above, the projections preferably but not necessarily take the form of annular ribs.

[0051] Each of the test or calibration plugs 86, 88, 90, 98 in the kit 80 may be provided on each end with a recess (e.g., slot) or an axial projection (e.g., tongue or plate), while each of the long-term plugs, 92, 94, 96 might bear such a formation on only one end, that is, the outer end, for facilitating insertion and optional removal procedures. The recesses and projections on the test or calibration plugs 86, 88, 90, 98 mate with complementary formations on other test or calibration plugs 86, 88, 90, 98, preventing or reducing undue relative rotation between adjacent plug elements. The end formations on the long-term plugs, 92, 94, 96 cooperate with a deployment tool 102 for facilitating insertion and optional retraction procedures. Tool 102 is configured for rotating a deployed plug (test or long-term) that is disposed in an ocular canaliculus. Tool 102 includes a flexible shaft 103 and a distal tip 104 with a geometric configuration that is rotatively lockable to and removable from the deployed plug. Tool tip 104 may include one or more fingers or nubs 106 that are alternately insertable into and removal from respective undercuts 108 and 110 (FIG. 10) in an ocular plug 112. Undercuts 108 and 100 communicate with a slot 114 that receive the tip 104 of tool 102. Fingers or nubs 106 and undercuts 108 and 110 enable the application of a tensile force on the canalicular plugs, so that the plugs are entrained to the tool and more easily extractable from a canaliculus. It is to be noted that the removal of plugs is likely rare and carried out only under unusual circumstances.

[0052] A method for treating dry eye syndrome utilizing kit 80 comprises inserting a selected long-term canalicular plug 96 into an upper canaliculus of a patient's eye. The method further comprises carrying out a titrating or calibration process to determine an optimal length of a long-term canalicular plug for a lower canaliculus of the patient's eye. The testing or calibration process includes inserting a first test or calibration plug 86, 88, or 90 or one of plugs 98 into the lower canaliculus of the patient's eye. Thereafter, the patient wears long-term plug 96 and the first test plug 86, 88, 90, 98 during a first testing period of predetermined duration, typically two to three weeks, during which the patient monitors tear accumulation in his or her eye. If necessary, that is, if dry eye symptoms persist, a second test or calibration plug 86, 88, 90, 98 is inserted into the lower canaliculus of the patient's eye and adjacent or over the first test or calibration plug 86, 88, 90, 98. The second test or calibration plug typically has length that is a fraction of the length of the first test or calibration plug. (However, a set of modular calibration plugs of the same length may be used in the titrating or fitting process.) The patient then monitors eye moisture for another period of typically two to three weeks. Upon a determination that tear accumulation in the patient's eye is satisfactory, the inserted test or calibration plugs 86, 88, 90, 98 are allowed to remain in the patient's canaliculus for an extended period of up to 5 or 6 months. Alternatively, but typically unnecessary, the test or calibration plugs are removed from the lower canaliculus of the patient's eye and replaced with a final canalicular plug cut from blank 92 or selected from plugs 94, this final canalicular plug having a length that is at least approximately equal to a sum of the lengths of the test or calibration plugs 86, 88, 90, 98 that provided a satisfactory or optimal correction of the patient's dry eye symptoms.

[0053] In general, it is contemplated that the fitting of one canaliculus of an upper and lower pair is achieved by a series of test plug sets. A long-term plug has a length selected in accordance with the results of the test plug sets. If dry eye symptoms persist with any one test plug set, then the length of any long-term plug for the patient will be longer than the combined lengths of that test plug set. Conversely, if epiphora results with any selected test plug set, then the length of any long-term or extended-wear plug will be shorter than the combined lengths of that selected test plug set. It is possible to select a length of a long-term plug on the basis of an interpolation where one test plug set results in dry eye symptoms and a next-longer test plug set results in epiphora.

[0054] The inserting of the long-term and calibration plugs and the removing of the calibration or fitting plugs may be implemented by rotating the plugs during the exertion of a pushing or pulling force on the plugs.

[0055] The canalicular plugs described herein comprise hydrophilic and biodegradable materials known in the medical industry. Examples include aliphatic polyesters such as polyglycolic acid (PGA), polylactic acid (PLA), Poly ε-caprolactone (PCL), etc.; polyaminoacids, and co-polymers of polyamino acids.

[0056] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.