Lacrimal insert having reservoir with controlled release of medication and method of manufacturing the same

• US 20060020248A1
• Filed: 07/26/2004
• Published: 01/26/2006
• Est. Priority Date: 07/26/2004
• Status: Active Grant

• Current Assignee: Katena Products, Inc. (Corza Medical Inc.)
• Original Assignee: Claria Corporation
• Inventors: Prescott, Anthony D.
• Granted Patent: US 7,117,870 B2
• Time in Patent Office: Days
• US Class Current: 604/294
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts

Abstract

A lacrimal insert includes a body defining a reservoir, and a head provided at an end of the body and closing the reservoir. The body is made from a material impermeable to the medication while the head is made from a permeable material adapted to release the medication from the reservoir to the eye at a determinable rate. In one manufacture, the body of the insert is molded and includes a hole at a tip end; the head is molded onto the body; the medication is injected into the insert through the tip end hole; and the tip end is sealed. The portion of the insert at which the medication is released is precisely fabricated in order to control release of the medication, and the reservoir is filled and then closed away from the area of medication permeability.

Claims

1. A lacrimal insert for insertion into a portion of the lacrimal canaliculus of an eye and for storing and releasing a medication to the eye, comprising:

a) a body portion made of a first material having a first permeability relative to the medication and defining a reservoir for said medication;

b) said medication in said reservoir; and

c) a non-porous head portion enclosing said reservoir and made of a second material having a second relatively greater permeability to said medication.

2. A lacrimal insert according to claim 1, wherein:

said insert is sized for insertion into the portion of the lacrimal canaliculus of a human eye.

3. A lacrimal insert according to claim 1, wherein:

said first permeability is substantially impermeability.

4. A lacrimal insert according to claim 1, further comprising:

d) a stopper element,

wherein said body portion defines a hole at a location spaced apart from said head portion, and said stopper element is provided in said hole.

5. A lacrimal insert according to claim 1, wherein:

said head portion does not include said first material.

6. A lacrimal insert according to claim 1, wherein:

said first and second materials are silicones.

7. A lacrimal insert for insertion into a portion of the lacrimal canaliculus of an eye and for storing and releasing a medication to the eye, comprising:

a) a first portion made of a first material having a first permeability relative to the medication, said first portion defining a head, a neck, a body and an internal space;

b) a tip portion coupled to first portion at an end opposite said head of said first portion, said tip portion enclosing said internal space so as to define a reservoir and made of a second material having a second relatively greater permeability to said medication; and

c) a medication provided within said reservoir.

8. A lacrimal insert according to claim 7, wherein:

said insert is sized for insertion into the lacrimal canaliculus of a human eye.

9. A lacrimal insert according to claim 7, wherein:

said first permeability is substantially impermeability.

10. A lacrimal insert according to claim 7, further comprising:

d) a seal element,

wherein said body portion defines a hole at a location spaced apart from said tip portion, and said seal element is provided in said hole.

11. A lacrimal insert according to claim 7, wherein:

said first and second materials are silicones.

12. A method of manufacturing a lacrimal insert, comprising:

a) molding a lacrimal insert sized for insertion into the lacrimal punctum, the insert having an internal medication-storing reservoir, and having portions which are relatively permeable and impermeable to the medication; and

b) injecting the medication into the reservoir at a location spaced apart from the permeable portion.

13. A method according to claim 12, further comprising:

sealing the insert at the location at which the medication is injected.

14. A method according to claim 12, wherein:

said molding includes molding the insert from two different silicones, one of which is permeable to the medication and the other of which is relatively impermeable to the medication.

15. A method of manufacturing a lacrimal insert, comprising:

a) providing a body of the lacrimal insert sized for insertion into the lacrimal punctum, the body of the insert having neck and tip ends, and defining an internal space which is open at both the neck and tip ends, the body being made from a first material;

b) providing a head of the insert onto the neck end of the body to partially enclose the internal space and define a reservoir, the head being made from a second material;

c) injecting medication into the reservoir of the insert through the tip end of the body; and

d) sealing the tip end of the body closed,

wherein the first material is relatively impermeable to the medication and the second material is relatively permeable to the medication so as to release the medication through the head of the insert at a determinable rate.

16. A method according to claim 15, wherein:

said providing the head of the insert onto the neck end of the body includes molding the head of the insert onto the neck end of the body.

17. A method according to claim 15, wherein:

said first and second materials are different silicones.

18. A method according to claim 15, wherein:

said sealing includes providing a stopper element in the open tip end.

19. A method of manufacturing a lacrimal insert, comprising:

a) providing a body of the lacrimal insert sized for insertion into the lacrimal punctum, the body of the insert having head, neck and open end, and defining an internal space and an opening in the head, the body made from a first material;

b) providing a tip of the insert onto the open end of the body to partially enclose the internal space and define a reservoir, the tip made from a second material;

c) injecting medication into the reservoir of the insert through the opening in the head of the body; and

d) sealing the opening in the head of the body closed,

wherein the first material is relatively impermeable to the medication and the second material is relatively permeable to the medication so as to release the medication through the head of the insert at a determinable rate.

20. A method according to claim 19, wherein:

said providing the tip of the insert onto the open end of the body includes molding the tip of the insert onto the open end of the body.

21. A method according to claim 19, wherein:

said first and second materials are different silicones.

22. A method according to claim 19, wherein:

said sealing includes providing a stopper element in the opening in the head.