Lacrimal implants and related methods

• US 10,434,009 B2
• Filed: 09/18/2017
• Issued: 10/08/2019
• Est. Priority Date: 09/07/2007
• Status: Active Grant

• Current Assignee: Mati Therapeutics, Inc
• Original Assignee: Mati Therapeutics, Inc
• Inventors: Rapacki, Alan R., Rubinchik, Valery, Holds, John B., Sim, Sylvie, Shen, Danny
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/707,386
• Publication Number:
  US 20180000642A1
• Time in Patent Office: 750 Days
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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
• CPC Class Codes: Y10T 407/19 Rotary cutting tool
• CPC Class Codes: Y10T 409/304256 Means to remove flash or burr

Abstract

Lacrimal implants for treating diseases or disorders are disclosed. More particularly, lacrimal implants, methods of making such implants, and methods of treating ocular, respiration, inner ear or other diseases or disorders using such implants are disclosed.

Claims

1. A lacrimal implant for insertion into a lacrimal canaliculus, comprising:

an implant body, comprising a first and second portions, the implant body non-linearly extending from a proximal end portion positionable within a vertical section of the lacrimal canaliculus to a distal end portion positionable within a horizontal section of the lacrimal canaliculus and having an intermediate portion therebetween, the proximal end of the first portion defining a longitudinal proximal axis and the distal end of the second portion defining a longitudinal distal axis, the first portion including a cavity;

a therapeutic agent disposed in the cavity;

the intermediate portion partially extending in a first direction toward the proximal end portion, partially extending in a second direction toward the distal end portion, and partially extending in a third direction along the longitudinal distal axis, configured to bias against a portion of a lacrimal canaliculus ampulla wherein the third direction is perpendicular to the first direction of the intermediate portion, such that, when implanted in the lacrimal canaliculus, the implant body directionally biases laterally against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature.

2. The implant of claim 1, wherein the therapeutic agent is selected from the group consisting of thrombin inhibitors;

antithrombogenic agents;

thrombolytic agents;

fibrinolytic agents;

vasospasm inhibitors;

vasodilators;

antihypertensive agents;

antimicrobial agents;

antibiotic agents;

antifungal agents;

antiviral agents;

inhibitors of surface glycoprotein receptors;

antiplatelet agents;

antimitotics;

microtubule inhibitors;

anti-secretory agents;

active inhibitors;

remodeling inhibitors;

antisense nucleotides;

anti-metabolites;

antiproliferatives;

anticancer chemotherapeutic agents;

anti-inflammatories;

non-steroidal anti-inflammatories (NSAIDs);

prostaglandins, prostaglandin analogues, antiprostaglandins, prostaglandin precursors, acetazolamide, dorzolamide, brinzolamide, methazolamide, dichlorphenamide, diamox;

lubezole, nimodipine, pilocarpine, carbachol, physostigmine and combinations thereof.

3. The implant of claim 1, wherein the therapeutic agent is a glaucoma drug selected from Timolol, betaxolol, levobunolol, atenolol, bimatoprost, travoprost, and latanoprost.

4. The implant of claim 1, wherein the therapeutic agent is dorzolamide, olopatadine, travoprost, bimatoprost, cyclosporin, brimonidine, moxifloxacin, tobramycin, brinzolamide, aciclovir timolol maleate, ketorolac tromethamine, prednisolone acetate, sodium hyaluronate, nepafenac, bromfenac, diclofenac, flurbiprofen, suprofenac, binoxan, patanol, dexamethasone/tobramycin combination, moxifloxacin, or acyclovir.

5. The implant of claim 1, wherein the therapeutic agent treats at least one of glaucoma, pre- and post-surgical ocular indications, dry eye, eye allergy symptoms, ocular infection, or post-surgical inflammation or pain.

6. The implant of claim 1, wherein the implant body comprises silicone.

7. The implant of claim 1, wherein a drug insert comprising the therapeutic agent is disposed in the cavity.

8. The implant of claim 7, wherein the drug insert comprises a matrix and a sheath body disposed over at least a portion of the matrix and therapeutic agent to define at least one insert exposed surface located at or near the proximal end of the first portion implant body.

9. The implant of claim 8, wherein the matrix comprises silicone, acrylates, polyethylenes, polyurethane, polyurethane, hydrogel, polyester, polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, extruded collagen, polymer foam, silicone rubber, polyethylene terephthalate, ultra high molecular weight polyethylene, polycarbonate urethane, polyurethane, polyimides, stainless steel, nickel-titanium alloy, titanium, stainless steel, cobalt-chrome alloy, protein, polyglycolic acid (PGA), polylactic acid (PLA), poly(L-lactic acid) (PLLA), poly(L-glycolic acid) (PLGA), polyglycolide, poly-L-lactide, poly-D-lactide, poly(amino acids), polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, polyorthoesters, polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(alpha-hydroxy acid) or combinations thereof.

10. The implant of claim 1, wherein the implant body is configured such that an angled intersection exists between the proximal axis and the distal axis prior to being implanted in the lacrimal canaliculus.

11. The implant of claim 10, wherein the angled intersection is between 45 degrees and 135 degrees.

12. The implant of claim 1, wherein the second portion includes an integral dilator, the integral dilator generally narrowing from a location near a proximal end of the second portion to the distal end of the second portion to facilitate implantation of the implant body into the lacrimal canaliculus.

13. The implant of claim 12, wherein a diameter of an integral dilator tip is between about 0.2 millimeters and about 0.5 millimeters.

14. The implant of claim 1, wherein the implant body comprises a graspable projection extending at least partially from the proximal end of the first portion, the graspable projection configured to seat against or near a lacrimal punctum when the implant body is implanted.

19. A kit comprising a lacrimal implant of claim 1, and an instruction for using the lacrimal implant to treat at least one of glaucoma, pre-and post-surgical ocular indications, dry eye, eye allergy symptoms, ocular infection, or post-surgical inflammation or pain.

15. A lacrimal implant insertable into a lacrimal canaliculus,

comprising:

an implant body, including first and second portions, the implant body extending from a proximal end of the first portion to a distal end of the second portion, the first portion including a cavity;

a therapeutic agent disposed in the cavity;

the proximal end of the first portion defining a longitudinal proximal axis and the distal end of the second portion defining a longitudinal distal axis;

the implant body configured such that, when implanted in the lacrimal canaliculus, an angled intersection exists between the proximal axis and the distal axis for biasing at least a portion of the implant body against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature; and

wherein the second portion of the implant body includes a longitudinal length having a magnitude less than four times a longitudinal length of the first portion of the implant body and wherein the second portion includes an element extending or expanding laterally into a lacrimal canaliculus ampulla when the implant body is implanted.

16. The implant of claim 15, wherein the therapeutic agent is selected from the group consisting of thrombin inhibitors;

antithrombogenic agents;

thrombolytic agents;

fibrinolytic agents;

vasospasm inhibitors;

vasodilators;

antihypertensive agents;

antimicrobial agents;

antibiotic agents;

antifungal agents;

antiviral agents;

inhibitors of surface glycoprotein receptors;

antiplatelet agents;

antimitotics;

microtubule inhibitors;

anti-secretory agents;

active inhibitors;

remodeling inhibitors;

antisense nucleotides;

anti-metabolites;

antiproliferatives;

anticancer chemotherapeutic agents;

anti-inflammatories;

non-steroidal anti-inflammatories (NSAIDs);

prostaglandins, prostaglandin analogues, antiprostaglandins, prostaglandin precursors, acetazolamide, dorzolamide, brinzolamide, methazolamide, dichlorphenamide, diamox;

lubezole, nimodipine, pilocarpine, carbachol, physostigmine and combinations thereof.

17. The implant of claim 15, wherein the therapeutic agent is a glaucoma drug selected from Timolol, betaxolol, levobunolol, atenolol, bimatoprost, travoprost, latanoprost, dorzolamide, olopatadine, cyclosporin, brimonidine, moxifloxacin, tobramycin, brinzolamide, aciclovir timolol maleate, ketorolac tromethamine, prednisolone acetate, sodium hyaluronate, nepafenac, bromfenac, diclofenac, flurbiprofen, suprofenac, binoxan, patanol, dexamethasone/tobramycin combination, moxifloxacin, or acyclovir.

18. The implant of claim 15, wherein the therapeutic agent treats at least one of glaucoma, pre-and post-surgical ocular indications, dry eye, eye allergy symptoms, ocular infection, or post-surgical inflammation or pain.

20. A kit comprising a lacrimal implant of claim 15, and an instruction for using the lacrimal implant to treat at least one of glaucoma, pre-and post-surgical ocular indications, dry eye, eye allergy symptoms, ocular infection, or post-surgical inflammation or pain.