US6234175B1
Expired / Lapsed
US
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Smart ocular plug design and method of insertion for punctal and intracanalicular implants
Assignee: Medennium Inc
•
Filing: 1999-07-27
•
Granted: 2001-05-22
•
Expires: 2019-07-27
Abstract
Abstract An ocular plug design and method of insertion is described for the treatment of dry eye. This ocular plug is a narrow rod-like cylinder of appropriate diameter, which is tapered at one end, for insertion into an ocular channel. The plug is prepared from either (or both) of two specific classes of polymeric materials having both viscous and elastic properties. The first class of polymeric materials have a glass transition temperature (T g ) at or below human body temperature (37° C.). The second class of polymeric materials have a melting temperature (T m ) at or below human body temperature (37° C.). The plug is stored in a frozen, rigid, elongated state prior to insertion into an ocular channel. Once inserted into an ocular channel, the smart plug responds to an increase in temperature, due to the surrounding physiochemical environment, whereby it becomes soft and the plug subsequently expands to adapt to the size and shape of the patient's punctum or canaliculum. Once the plug expands to the size of the particular ocular channel, the plug is met with a resistance from the surrounding tissue. At this point, expansion of the plug ceases and the plug can effectively block tear drainage through either ocular channel.
Inventors
- 👤 Stephen Q. Zhou
- 👤 Christopher D. Wilcox
- 👤 Julian Abadia
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 01:48
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/14; A61L27/16; A61L31/00; A61L31/04; A61L31/048; A61L2430/00; A61L2430/16
Claims Analysis
Total Claims: 51
Claim 1
Independent Claim
143 words
A method for inserting a plug into an ocular channel, comprising the steps of: (a) providing a biocompatible composition which: i. is rigid at room temperature; ii. becomes elastic when warmed to a temperature above its melting temperature, T m ; iii. becomes rigid again when cooled to temperature below its T m ; and iv. comprises a material selected from the group consisting of polymeric materials and mixtures of polymeric materials and waxes; (b) warming said composition to a temperature at which it becomes elastic; (c) forming said composition into dimensions suitable for insertion into an ocular channel; (d) allowing said composition to cool and re-solidify in its stretched form; (e) inserting said stretched, rigid composition into an ocular channel; (f) allowing said composition to warm to the body's temperature thereby becoming elastic and conforming to the shape of the ocular channel.
Claim 2
Independent Claim
143 words
A method for inserting a plug into an ocular channel, comprising the steps of: (a) providing a biocompatible composition which: i. is rigid at room temperature; ii. becomes elastic when warmed to a temperature above its melting temperature, T m ; iii. becomes rigid again when cooled to temperature below its T m ; and iv. comprises a material selected from the group consisting of polymeric materials and mixtures of polymeric materials and waxes; (b) warming said composition to a temperature at which it becomes elastic; (c) forming said composition into dimensions suitable for insertion into an ocular channel; (d) allowing said composition to cool and re-solidify in its stretched form; (e) inserting said stretched, rigid composition into an ocular channel; (f) allowing said composition to warm to the body's temperature thereby becoming elastic and conforming to the shape of the ocular channel.
Claim 3
Dependent Claim
30 words
The method of claim 1 wherein said composition conforms to the shape of the ocular channel in from about 1 second to about 120 seconds after it has been inserted.
Claim 4
Dependent Claim
30 words
The method of claim 1 wherein said polymeric material is selected from the group consisting of polymers, homopolymers, cross-linked polymers and copolymers of acrylic esters, silicone elastomers, and combinations thereof.
Claim 5
Dependent Claim
44 words
The method of claim 3 wherein said polymeric material is a side-chain crystallizable polymer which comprises an acrylic ester of the formula: wherein X is H, or a C 1 -C 6 alkyl radical; R is a linear C 10 -C 26 alkyl radical.
Claim 6
Dependent Claim
20 words
The method of claim 3 wherein said polymeric material is a main-chain crystallizable polymer comprising the silicone elastomer stereoregular poly[methyl(3,3,3-trifluoropropyl)siloxane].
Claim 7
Dependent Claim
35 words
The method of claim 3 wherein said polymeric material in its stretched form is in the shape of a cylindrical rod-shaped implant which is tapered at one end to facilitate insertion into the ocular channel.
Claim 8
Dependent Claim
35 words
The method of claim 6 wherein said implant has a length of from about 1 mm to about 5 mm and a diameter of from about 0.5 mm to about 2.5 mm prior to stretching.
Claim 9
Dependent Claim
36 words
The method of claim 6 wherein said implant in its stretched form has a length of from about 3 mm to about 20 mm and a diameter of from about 0.25 mm to about 1.25 mm.
Claim 10
Dependent Claim
12 words
The method of claim 8 wherein said polymeric material comprises poly(stearyl methacrylate).
Claim 11
Dependent Claim
18 words
The method of claim 1 wherein said composition has a T m of less than about 37° C.
Claim 12
Dependent Claim
18 words
The method of claim 3 wherein said implant is adapted for insertion into the punctum or the canaliculus.
Claim 13
Independent Claim
144 words
A method for inserting a plug into an ocular channel, comprising the steps of: (a) providing a biocompatible composition which: i. is rigid at room temperature; ii. becomes elastic when warmed to a temperature above its glass transition temperature, T g ; iii. becomes rigid again when cooled to temperature below its T g ; and iv. comprises a material selected from the group consisting of polymeric materials and mixtures of polymeric materials and waxes; (b) warming said composition to a temperature at which it becomes elastic; (c) forming said composition into dimensions suitable for insertion into an ocular channel; (d) allowing said composition to cool and re-solidify in its de-formed state; (e) inserting said stretched, rigid composition into an ocular channel; (f) allowing said composition to warm to the body's temperature thereby becoming elastic and conforming to the shape of the ocular channel.
Claim 14
Independent Claim
144 words
A method for inserting a plug into an ocular channel, comprising the steps of: (a) providing a biocompatible composition which: i. is rigid at room temperature; ii. becomes elastic when warmed to a temperature above its glass transition temperature, T g ; iii. becomes rigid again when cooled to temperature below its T g ; and iv. comprises a material selected from the group consisting of polymeric materials and mixtures of polymeric materials and waxes; (b) warming said composition to a temperature at which it becomes elastic; (c) forming said composition into dimensions suitable for insertion into an ocular channel; (d) allowing said composition to cool and re-solidify in its de-formed state; (e) inserting said stretched, rigid composition into an ocular channel; (f) allowing said composition to warm to the body's temperature thereby becoming elastic and conforming to the shape of the ocular channel.
Claim 15
Dependent Claim
27 words
The method of claim 12 wherein said composition fills and occludes the ocular channel in about 1 minute to about 7 minutes after it has been inserted.
Claim 16
Dependent Claim
32 words
The method of claim 13 wherein said polymeric material is selected from the group consisting of polymers, homopolymers, cross-linked polymers and copolymers of silicones, acrylic esters, polyurethanes, hydrocarbon polymers and combinations thereof.
Claim 17
Dependent Claim
13 words
The method of claim 14 wherein said polymeric material is an acrylic ester.
Claim 18
Dependent Claim
35 words
The method of claim 14 wherein said polymeric material in its stretched form is in the shape of a cylindrical rod-shaped implant which is tapered at one end to facilitate insertion into the ocular channel.
Claim 19
Dependent Claim
35 words
The method of claim 16 wherein said implant has a length of from about 1 mm to about 5 mm and a diameter of from about 0.5 mm to about 2.5 mm prior to stretching.
Claim 20
Dependent Claim
36 words
The method of claim 16 wherein said implant in its stretched form has a length of from about 3 mm to about 20 mm and a diameter of from about 0.25 mm to about 1.25 mm.
Claim 21
Dependent Claim
17 words
The method of claim 18 wherein said implant is comprised of a copolymer of polymethylmethacrylate and polylaurylmethacrylate.
Claim 22
Dependent Claim
18 words
The method of claim 12 wherein said composition has a T g of less than about 37° C.
Claim 23
Dependent Claim
18 words
The method of claim 14 wherein said implant is adapted for insertion into the punctum or the canaliculus.
Claim 24
Dependent Claim
120 words
A removable rod shape plug for blocking lacrimal flow through the punctum or canaliculus of the human eye comprising a biocompatible composition which: a) is rigid at room temperature; b) becomes elastic when warmed to a temperature above its melting temperature, T m ; c) becomes rigid again when cooled to temperature below its T m ; d) comprises a material selected from the group consisting of polymeric materials, waxes, and mixtures thereof; said composition being formed into a cylindrical shape of diameter and length which is sufficient to fully occlude the ocular channel and having a tapered end to facilitate insertion into the punctum or canaliculus; said plug being stretched along its length and frozen in said elongated form.
Claim 25
Dependent Claim
120 words
A removable rod shape plug for blocking lacrimal flow through the punctum or canaliculus of the human eye comprising a biocompatible composition which: a) is rigid at room temperature; b) becomes elastic when warmed to a temperature above its melting temperature, T m ; c) becomes rigid again when cooled to temperature below its T m ; d) comprises a material selected from the group consisting of polymeric materials, waxes, and mixtures thereof; said composition being formed into a cylindrical shape of diameter and length which is sufficient to fully occlude the ocular channel and having a tapered end to facilitate insertion into the punctum or canaliculus; said plug being stretched along its length and frozen in said elongated form.
Claim 26
Dependent Claim
30 words
The plug of claim 22 wherein said polymeric material is selected from the group consisting of polymers, homopolymers, cross-linked polymers and copolymers of acrylic esters, silicone elastomers and combinations thereof.
Claim 27
Dependent Claim
19 words
The plug of claim 23 wherein said polymeric material has a T m of less than about 37° C.
Claim 28
Dependent Claim
44 words
The plug of claim 24 wherein said polymeric material is a side-chain crystallizable polymer which comprises an acrylic ester of the formula: wherein X is H or a C 1 -C 6 alkyl radical; R is a linear C 10 -C 26 alkyl radical.
Claim 29
Dependent Claim
17 words
The plug of claim 24 wherein said polymeric material is a main-chain crystallizable polymer comprising stereoregular poly[methyl(3,3,3-trifluoropropyl)siloxane].
Claim 30
Dependent Claim
12 words
The plug of claim 24 wherein said polymeric material is poly(stearyl methacrylate).
Claim 31
Dependent Claim
45 words
A method for removing the plug of claim 22 from the ocular channel by lowering the temperature of the area surrounding the ocular channel to below the T m of the material, in order to cause the material to become rigid to aid in excision.
Claim 32
Dependent Claim
121 words
A removable rod shape plug for blocking lacrimal flow through the punctum or canaliculus of the human eye comprising a biocompatible composition which: a) is rigid at room temperature; b) becomes elastic when warmed to a temperature above its glass transition temperature, T g ; c) becomes rigid again when cooled to temperature below its T g ; d) comprises a material selected from the group consisting of polymeric materials, waxes, and mixtures thereof; said composition being formed into a cylindrical shape of diameter and length which is sufficient to fully occlude the ocular channel and having a tapered end to facilitate insertion into the punctum or canaliculus; said plug being stretched along its length and frozen in said elongated form.
Claim 33
Dependent Claim
121 words
A removable rod shape plug for blocking lacrimal flow through the punctum or canaliculus of the human eye comprising a biocompatible composition which: a) is rigid at room temperature; b) becomes elastic when warmed to a temperature above its glass transition temperature, T g ; c) becomes rigid again when cooled to temperature below its T g ; d) comprises a material selected from the group consisting of polymeric materials, waxes, and mixtures thereof; said composition being formed into a cylindrical shape of diameter and length which is sufficient to fully occlude the ocular channel and having a tapered end to facilitate insertion into the punctum or canaliculus; said plug being stretched along its length and frozen in said elongated form.
Claim 34
Dependent Claim
32 words
The plug of claim 29 wherein said polymeric material is selected from the group consisting of polymers, homopolymers, cross-linked polymers and copolymers of silicones, acrylic esters, polyurethanes, hydrocarbon polymers and combinations thereof.
Claim 35
Dependent Claim
19 words
The plug of claim 30 wherein said polymeric material has a T g of less than about 37° C.
Claim 36
Dependent Claim
13 words
The plug of claim 31 wherein said polymeric material is an acrylic ester.
Claim 37
Dependent Claim
16 words
The plug of claim 32 wherein said polymeric material is a copolymer of polymethylmethacrylate and polylaurylmethacrylate.
Claim 38
Dependent Claim
45 words
A method for removing the plug of claim 29 from the ocular channel by lowering the temperature of the area surrounding the ocular channel to below the T g of the material, in order to cause the material to become rigid to aid in excision.
Claim 39
Dependent Claim
182 words
A process for manufacturing punctum plugs or intracanalicular plugs comprising the steps of: (a) polymerizing a material in the shape of a cylindrical rod which: i. is rigid at room temperature; ii. becomes elastic when warmed to a temperature above its melting temperature, T m ; iii. becomes rigid again when cooled to a temperature below its T m ; iv. has a diameter of at least 0.5 mm and a length sufficient to form two or more plugs from the same rod; v. comprises a material selected from the group consisting of polymeric materials and mixtures of polymeric materials and waxes; (b) stretching said rod at a temperature above its T m to a final length which is at least twice that of its initial length; (c) allowing said stretched rod to cool to a temperature below its T m and re-solidify in its stretched form; (d) cutting said stretched rod to an appropriate length so that at least two plugs can be fashioned from the same rod; (e) sharpening one end of said stretched rod so that it is tapered.
Claim 40
Dependent Claim
182 words
A process for manufacturing punctum plugs or intracanalicular plugs comprising the steps of: (a) polymerizing a material in the shape of a cylindrical rod which: i. is rigid at room temperature; ii. becomes elastic when warmed to a temperature above its melting temperature, T m ; iii. becomes rigid again when cooled to a temperature below its T m ; iv. has a diameter of at least 0.5 mm and a length sufficient to form two or more plugs from the same rod; v. comprises a material selected from the group consisting of polymeric materials and mixtures of polymeric materials and waxes; (b) stretching said rod at a temperature above its T m to a final length which is at least twice that of its initial length; (c) allowing said stretched rod to cool to a temperature below its T m and re-solidify in its stretched form; (d) cutting said stretched rod to an appropriate length so that at least two plugs can be fashioned from the same rod; (e) sharpening one end of said stretched rod so that it is tapered.
Claim 41
Dependent Claim
30 words
The process of claim 35 wherein said polymeric material is selected from the group consisting of polymers, homopolymers, cross-linked polymers and copolymers of acrylic esters, silicone elastomers and combinations thereof.
Claim 42
Dependent Claim
44 words
The process of claim 36 wherein said polymeric material is a side-chain crystallizable polymer which comprises an acrylic ester of the formula: wherein X is H or a C 1 -C 6 alkyl radical; R is a linear C 10 -C 26 alkyl radical.
Claim 43
Dependent Claim
12 words
The process of claim 37 wherein said polymeric material is poly(stearyl methacrylate).
Claim 44
Dependent Claim
17 words
The process of claim 36 wherein said polymeric material is a main-chain crystallizable polymer comprising stereoregular poly[methyl(3,3,3-trifluoropropyl)siloxane].
Claim 45
Dependent Claim
19 words
The process of claim 35 wherein said polymeric material has a T m of less than about 37° C.
Claim 46
Dependent Claim
183 words
A process for manufacturing punctum plugs or intracanalicular plugs comprising the steps of: (a) polymerizing a material in the shape of a cylindrical rod which: i. is rigid at room temperature; ii. becomes elastic when warmed to a temperature above its glass transition temperature, T g ; iii. becomes rigid again when cooled to a temperature below its T g ; iv. has a diameter of at least 0.5 mm and a length sufficient to form two or more plugs form the same rod; v. comprises a material selected from the group consisting of polymeric materials and mixtures of polymeric materials and waxes; (b) stretching said rod at a temperature above its T g to a final length which is at least twice that of its initial length; (c) allowing said stretched rod to cool to a temperature below its T g and re-solidify in its stretched form; (d) cutting said stretched rod to an appropriate length so that at least two plugs can be fashioned from the same rod; (e) sharpening one end of said stretched rod so that it is tapered.
Claim 47
Dependent Claim
183 words
A process for manufacturing punctum plugs or intracanalicular plugs comprising the steps of: (a) polymerizing a material in the shape of a cylindrical rod which: i. is rigid at room temperature; ii. becomes elastic when warmed to a temperature above its glass transition temperature, T g ; iii. becomes rigid again when cooled to a temperature below its T g ; iv. has a diameter of at least 0.5 mm and a length sufficient to form two or more plugs form the same rod; v. comprises a material selected from the group consisting of polymeric materials and mixtures of polymeric materials and waxes; (b) stretching said rod at a temperature above its T g to a final length which is at least twice that of its initial length; (c) allowing said stretched rod to cool to a temperature below its T g and re-solidify in its stretched form; (d) cutting said stretched rod to an appropriate length so that at least two plugs can be fashioned from the same rod; (e) sharpening one end of said stretched rod so that it is tapered.
Claim 48
Dependent Claim
32 words
The process of claim 41 wherein said polymeric material is selected from the group consisting of polymers, homopolymers, cross-linked polymers and copolymers of silicones, acrylic esters, polyurethanes, hydrocarbon polymers and combinations thereof.
Claim 49
Dependent Claim
13 words
The process of claim 42 wherein said polymeric material is an acrylic ester.
Claim 50
Dependent Claim
19 words
The process of claim 41 wherein said polymeric material has a T g of less than about 37° C.
Claim 51
Dependent Claim
16 words
The process of claim 44 wherein said polymeric material is a copolymer of polymethylmethacrylate and polylaurylmethacrylate.
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