Composite Lacrimal Insert and Related Methods

• US 20150367037A1
• Filed: 08/21/2015
• Published: 12/24/2015
• Est. Priority Date: 04/30/2008
• Status: Active Grant

• Current Assignee: Mati Therapeutics, Inc
• Original Assignee: Mati Therapeutics, Inc
• Inventors: Sim, Sylvie, Jain, Rachna, Farinas, Kathleen
• Granted Patent: US 9,764,066 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics
• CPC Class Codes: A61P 27/14 Decongestants or antiallergics

Abstract

Lacrimal implants, methods of making lacrimal implants, and methods of treating ocular, respiration or other diseases or disorders using lacrimal implants are disclosed.

Claims

1. A lacrimal implant comprising:

an implant body, including first and second portions, sized and shaped for at least partial insertion into a lacrimal canaliculus,

the first portion including a first biocompatible polymer configured to swell less than 100 wt % when in contact with an aqueous medium,

the second portion including a second biocompatible polymer configured to swell greater than 100 wt % when in contact with an aqueous medium;

wherein the first and second biocompatible polymers adhere at a junction between the first portion and the second portion.

2. The lacrimal implant of claim 1, wherein the first biocompatible polymer is a polyurethane polymer or copolymer.

3. The lacrimal implant of claim 1, wherein the second biocompatible polymer is a hydrogel-forming polyurethane polymer or copolymer.

4. The lacrimal implant of claim 1, wherein the junction comprises an intermediate member including a third biocompatible polymer, the third biocompatible polymer configured to adhere to both the first biocompatible polymer and the second biocompatible polymer, and configured to swell upon contact with an aqueous medium to a greater degree than the first polymer but to a lesser degree than the second polymer.

5. The lacrimal implant of claim 4, wherein the third polymer comprises a polyurethane polymer or copolymer, a polyurethane-silicone copolymer, a polyurethane-carbonate copolymer, an aliphatic polyurethane, an aromatic polyurethane, or any combination thereof.

6. The lacrimal implant of claim 1, wherein the first portion comprises a base member extending from a proximal end, configured to sit at or near a lacrimal punctum when implanted and including a first diameter, to a distal end portion, configured for insertion through the lacrimal punctum into the lacrimal canaliculus when implanted and having a second diameter less than the first diameter.

7. The lacrimal implant of claim 6, wherein a shape of the base member is configured to provide sufficient surface area for adhesion of the first biocompatible polymer to the second biocompatible polymer, such that the first portion and the second portion do not separate at the junction when the implant body is withdrawn under tension from the lacrimal canaliculus and the second portion has swelled from contact with the aqueous medium.

8. The lacrimal implant of claim 6, wherein the second portion comprises an expandable retention member coupled at least partially over the base member, the expandable retention member configured to swell via absorption of an aqueous medium after insertion into the lacrimal canaliculus.

9. The lacrimal implant of claim 1, further comprising a first supply of a first active agent included in the first portion, the first supply configured to provide a release of the first active agent to an eye.

10. The lacrimal implant of claim 9, wherein the first portion includes a cavity extending inward from a proximal end of the first portion, the cavity comprising the first supply to provide the release of the first active agent to the eye.

11. The lacrimal implant of claim 9, wherein the first supply includes a solid matrix comprising a mixture of silicone and the first active agent.

12. The lacrimal implant of claim 9, wherein the first supply is dispersed within the first polymer.

13. The lacrimal implant of claim 9, further comprising a second supply of a second active agent included in the second portion, the second supply configured to provide a release of the second active agent to one or both of a lacrimal canaliculus wall or a nasolacrimal system after contact with an aqueous medium.

14. The lacrimal implant of claim 1, wherein an intermediate section of the first portion includes a coupling void and a coupling arm sized and shaped to lock within the coupling void.

15. A kit comprising the lacrimal implant of claim 1, and an instruction for using the lacrimal implant to treat an eye disease.

16. A method comprising:

forming an implant body, including first and second portions, sized for at least partial insertion into a lacrimal canaliculus, including

forming the first portion from a first biocompatible polymer configured to swell less than 100 wt % when in contact with an aqueous medium, and

forming the second portion from a second biocompatible polymer configured to swell greater than 100 wt % when in contact with an aqueous medium; and

coupling the first and second biocompatible polymers at a junction between the first portion and the second portion.

17. The method of claim 16, further comprising disposing an intermediate member including a third biocompatible polymer between the first and second portions, the third biocompatible polymer configured to adhere to the first biocompatible polymer on a first surface and adhere to the second biocompatible polymer on a second surface.

18. The method of claim 16, wherein forming the first portion includes forming a base member extending from a proximal end, configured to sit at or near a lacrimal punctum when implanted, to a distal end portion, configured for insertion through the lacrimal punctum into the lacrimal canaliculus when implanted, including forming one or more arm members protruding from an outer surface of the base member.

19. The method of claim 18, wherein adhering the first and second biocompatible polymers includes coupling an expandable retention member at least partially over the base member such that an outer surface of the expandable retention member can absorb the aqueous medium after insertion into the lacrimal canaliculus.

20. The method of claim 16, further comprising providing a first supply of a first active agent in the first portion, the first supply configured to provide a release of the first active agent to an eye.

21. A method of treating a subject having an eye disorder, the method comprising:

inserting a lacrimal implant into at least one lacrimal canaliculus, the lacrimal implant comprising,

an implant body, including first and second portions, sized and shaped for at least partial insertion into a lacrimal canaliculus,

the first portion including a first biocompatible polymer configured to swell less than 100 wt% when in contact with an aqueous medium,

the second portion including a second biocompatible polymer configured to swell greater than 100 wt% when in contact with an aqueous medium;

wherein the first and second biocompatible polymers adhere at a junction between the first portion and the second portion.

22. The method of claim 21, wherein inserting the lacrimal implant includes partially inserting the implant body through the lacrimal punctum until a removal projection extending laterally from the proximal end of the first portion is positioned outside and adjacent to the lacrimal punctum.

23. The method of claim 21, wherein inserting the lacrimal implant includes positioning a supply of an active agent, included in the first portion, adjacent an eye of the subject.

24. The method of claim 23, wherein the agent is configured to treat at least one of a glaucoma disease or a seasonal allergy.