Nasolacrimal drainage system implants for drug therapy

• US 9,168,222 B2
• Filed: 04/29/2014
• Issued: 10/27/2015
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Mati Therapeutics, Inc
• Original Assignee: Mati Therapeutics, Inc
• Inventors: De Juan, Eugene Jr., Boyd, Stephen, Reich, Cary, Rapacki, Alan, Deem, Mark, Gifford, Hanson S
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US14/265,071
• Publication Number:
  US 20140236293A1
• Time in Patent Office: 546 Days
• US Class Current: 1/1
• 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 2250/0087 colour-coded
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/0026 Ophthalmic product dispenser attachments to facilitate positioning near the eye
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 31/215 of carboxylic acids
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 31/557 Eicosanoids, e.g. leukotrienes or prostaglandins
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• 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 9/00 Medicinal preparations characterised by special physical form nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12
• CPC Class Codes: A61K 9/0017 Non-human animal skin, e.g. pour-on, spot-on
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• 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 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system

Abstract

An implant for insertion through a punctum and into a canalicular lumen of a patient. The implant includes a matrix of material, a therapeutic agent dispersed in the matrix of material, a sheath disposed over a portion of the matrix of material and configured to inhibit the therapeutic agent from being released from the matrix of material into the canalicular lumen and to allow the therapeutic agent to be released from a surface of the matrix of material to a tear film, and a retention structure configured to retain the implant within the canalicular lumen.

Claims

1. A method for delivery of a therapeutic agent to an eye, comprising:

placing a lacrimal implant through a punctum and into a canalicular lumen of a patient, the implant comprising;

a plug body comprising a drug insert;

the drug insert comprising;

a matrix of material;

a therapeutic agent dispersed in the matrix of material; and

a sheath disposed over a portion of the matrix of material and configured to inhibit the therapeutic agent from being released from the matrix of material into the canalicular lumen, wherein when the implant is inserted into the canalicular lumen an exposed surface of the drug insert is in direct contact with tear fluid to allow diffusion of the therapeutic agent from a surface of the matrix of material to a tear film of the eye.

2. The method according to claim 1, wherein the therapeutic agent comprises a prostaglandin analogue.

3. The method according to claim 2, wherein the prostaglandin analogue is selected from the group consisting of latanoprost, bimatoprost, and travoprost.

4. The method according to claim 1, wherein the matrix of material comprises a non-biodegradable polymer.

5. The method according to claim 4, wherein the matrix of material comprises silicone or urethane.

13. The method according to claim 1, wherein the therapeutic agent is a thrombin inhibitor, a fibrinolytic agent, a vasospasm inhibitor, a vasodilator, an antimicrobial agents, an antifungal, an antiviral, an anticancer chemotherapeutic agent, an anti-inflammatory agent, a non-steroidal anti-inflammatory agent, a hormonal agent, an immunosuppressive agent, a growth hormone antagonist, a growth factor, an angiogenesis inhibitor, a peptide, a protein, or an enzymes.

6. A method for delivery of a therapeutic agent to an eye, comprising:

placing a lacrimal implant into a punctum of a patient, the implant comprising;

a therapeutic agent;

a body of material that holds the therapeutic agent;

a retention structure configured to retain the body of material near the punctum.

7. The method according to claim 6, wherein the body of material holds the therapeutic agent in a reservoir and/or a matrix.

8. The method according to claim 7, wherein the body of material is a matrix comprising polymers selected from protein, hydrogel, 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) and combinations thereof.

9. The method according to claim 8, wherein the matrix comprises a hydrogel.

10. The method according to claim 6, wherein the therapeutic agent comprises a prostaglandin analogue.

11. The method according to claim 10, wherein the prostaglandin analogue is selected from the group consisting of latanoprost, bimatoprost, and travoprost.

12. The method according to claim 6, wherein the retention structure is configured to engage a luminal wall of the canalicular lumen to retain the implant within the canalicular lumen.

14. The method of claim 6, wherein the therapeutic agent is a thrombin inhibitor, a fibrinolytic agent, a vasospasm inhibitor, a vasodilator, an antimicrobial agents, an antifungal, an antiviral, an anticancer chemotherapeutic agent, an anti-inflammatory agent, a non-steroidal anti-inflammatory agent, a hormonal agent, an immunosuppressive agent, a growth hormone antagonist, a growth factor, an angiogenesis inhibitor, a peptide, a protein, or an enzymes.