Lacrimal filler

• US 8,979,821 B2
• Filed: 04/14/2009
• Issued: 03/17/2015
• Est. Priority Date: 04/14/2009
• Status: Active Grant

• Current Assignee: Fezza Family Properties, LLC
• Original Assignee: Fezza Family Properties, LLC
• Inventors: Fezza, John
• Primary Examiner(s): Arnold, Ernst V
• Assistant Examiner(s): Chang, Kyung Sook
• Application Number:
  US12/386,150
• Publication Number:
  US 20110066138A1
• Time in Patent Office: 2,163 Days
• Field of Search: 604/521, 604/285, 604/57, 514/54, 128/887, 424/427
• US Class Current: 604/521
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/08 Polysaccharides A61L24/043 takes precedence
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions

Abstract

A biomaterial mass is inserted through a punctum into a canaliculus in the lacrimal outflow system with a syringe. The mass has an outer cross section that is less than the inner cross section of the canaliculus. The mass absorbs liquid to swell to form a lacrimal filler or sealing mechanism. The lacrimal filler has an external cross section that conforms to the internal cross section of the canaliculus and a soft outer surface relative to the surrounding tissues to prevent erosion of the canaliculus lining. The lacrimal filler forms an occlusion that prevents the outflow of liquid through the lacrimal outflow system to retain tears within the eye to maintain eye lubrication and wetness. The mass and syringe are provided in kit with a rubber stopper and, optionally, a punctal dilator, an injecting catheter, and an enzyme for dissolving or degrading the lacrimal filler at a later time.

Claims

1. A method for treating dry eye, comprising the steps of:

inserting an injector through a puncta and into a canaliculus in a lacrimal outflow system;

inserting a swellable preformed hyaluronic acid gel occluder in a gel form from the injector and into the canaliculus, such that the gel absorbs liquid in the canaliculus and swells to conform to the interior of and form a soft seal within the canaliculus that does not erode the inner lining of the canaliculus, wherein the occluder is suspended in a solution having a hyaluronic acid concentration of between 15 mg/ml and 25 mg/ml, and

preventing the outflow of liquid through the lacrimal outflow system with the occluder to retain tears within the eye to maintain eye lubrication and wetness.

2. The method as set forth in claim 1, wherein:

the gel occluder is suspended in a solution having a hyaluronic acid concentration of about 22 mg/ml.

3. The method as set forth in claim 1, wherein the hyaluronic acid has a degree of crosslinking ranging from 10% to 100%.

4. The method as set forth in claim 3, wherein:

the hyaluronic acid has a degree of crosslinking ranging from 60% to 95%.

5. The method as set forth in claim 1, which further includes the step of:

inserting a puncta dilator into the puncta, and dilating the puncta to facilitate insertion of a syringe and a catheter into the canaliculus.

6. The method as set forth in claim 1, which further includes the step of:

unsealing the canaliculus with an enzyme.

7. The method as set forth in claim 1, which further includes the step of:

unsealing the canaliculus with hyaluronidase.

8. The method as set forth in claim 1, which further includes the step of:

dissolving the outer surface of the seal at a predetermined rate to deliver a drug.

9. The method as set forth in claim 8, which further includes the step of:

delivering a drug selected from the group consisting of a drug for treating glaucoma, a drug for treating allergies, steroids, and antibiotics from the gel occluder into the canaliculus.

10. The method as in claim 1, further comprising the step of releasing a drug from the gel occluder.

11. The method as in claim 10, wherein the drug comprises a glaucoma drug.

12. The method as in claim 10, wherein the drug comprises an allergy drug.

13. The method as in claim 10, wherein the drug comprises an antibiotic.

14. The method as in claim 10, wherein the drug comprises a steroid.