Lacrimal filler

• US 9,504,605 B2
• Filed: 03/06/2015
• Issued: 11/29/2016
• Est. Priority Date: 04/14/2009
• Status: Active Grant

• Current Assignee: Fezza Family Properties, LLC
• Original Assignee: Fezza Family Properties, LLC
• Inventors: Fezza, John P.
• Primary Examiner(s): Arnold, Ernst V
• Assistant Examiner(s): CHANG, KYUNG SOOK
• Application Number:
  US14/641,133
• Publication Number:
  US 20150173951A1
• Time in Patent Office: 634 Days
• Field of Search: None
• US Class Current: 1/1
• 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 kit for treating dry eyes comprising:

a syringe,

a lacrimal injector,

a biomaterial mass comprising a swellable preformed hyaluronic acid gel occluder in a gel form, the hyaluronic acid being present in a concentration of between 15 mg/ml and 25 mg/ml,

said lacrimal injector configured to inject said biomaterial mass into a canaliculus in the lacrimal outflow system to absorb liquid within the canaliculus and swell to conform the outer surface of the mass to the inner surface of the canaliculus to form a sealing mechanism for sealing the canaliculus at least partially,

said sealing mechanism outer surface being sufficiently soft relative to the inner surface of the canaliculus to prevent the sealing mechanism outer surface from eroding the canaliculus lining, and

said sealing mechanism forming an occlusion to prevent the outflow of liquid through the lacrimal outflow system to retain tears within the eye to maintain eye lubrication and wetness.

2. The kit as set forth in claim 1 which includes:

said biomaterial mass having hyaluronic acid in a form selected from the group consisting of hyaluronic acid crystals, hyaluronic acid crystals suspended in hyaluronic acid liquid, hyaluronic acid gel, hyaluronic acid gel particles with hyaluronic acid solid particles, and hyaluronic acid solid particles.

3. The kit as set forth in claim 1 wherein:

said biomaterial mass being suspended in a solution having a hyaluronic acid concentration of about 22 mg/ml.

4. The kit as set forth in claim 1, wherein:

said hyaluronic acid is cross-linked.

5. The kit as set forth in claim 4 wherein:

said hyaluronic acid having a degree of crosslinking ranging from 10% to 100% crosslinking.

6. The kit as set forth in claim 5 wherein:

said hyaluronic acid having a degree of crosslinking ranging from 60% to 95% crosslinking.

7. The kit as set forth in claim 1 which includes:

a punctal dilator for dilating the puncta to facilitate insertion of said syringe therein.

8. The kit as set forth in claim 1 which includes:

an enzyme for dissolving said sealing mechanism.

9. The kit as set forth in claim 8 which includes:

said enzyme being hyaluronidase.

10. The kit as set forth in claim 1 in which:

said sealing mechanism includes a drug for treating a condition.

11. The kit as set forth in claim 10 in which:

said sealing mechanism has an outer surface that dissolves at a predetermined rate to deliver said drug.

12. The kit as set forth in claim 11 in which:

said drug includes a drug selected from the group consisting of a drug for treating glaucoma, a drug for treating allergies, steroids, and antibiotics.

13. The kit as set forth in claim 1, wherein the biomaterial mass is housed within the syringe, the hyaluronic acid having a volume of from 0.1 cc to 1 cc.

14. 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 non-liquid 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, thereby 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

wherein the occluder is suspended in a solution having a hyaluronic acid concentration of between 15 mg/ml and 25 mg/ml.

15. A method as set forth in claim 14, wherein the hyaluronic acid is cross-linked.

16. A method as set forth in claim 14, further including inserting a puncta dilator into the puncta, and dilating the puncta to facilitate insertion of a syringe and a catheter into the canaliculus prior to inserting the injector through the puncta and into the canaliculus.