Lacrimal system drug delivery device

Abstract

This invention is in the field of medical intervention related to the lacrimal system. The invention relates to a lacrimal system device and methods of using the device for drug delivery to the eye, sinuses and/or periocular tissues.

We claim: 
     
         1 . A lacrimal system drug delivery device, comprising:
 a) a reservoir having a loading port and an exit port wherein said reservoir has elastic properties,   b) a first tube connected to said exit port, and   c) a second tube comprising a flow limiting port connected to said first tube.   
     
     
         2 . The device of  claim 1 , wherein said device further comprises a third tube connected to said loading port. 
     
     
         3 . The device of  claim 2 , wherein said elastic reservoir further comprises a fluid comprising a composition with an active ingredient. 
     
     
         4 . The device of  claim 1 , wherein said elastic reservoir enables anatomical fixation. 
     
     
         5 . The device of  claim 4 , wherein said anatomical fixation is a device retention feature. 
     
     
         6 . The device of  claim 1 , wherein said exit port is connected to an internal plunger. 
     
     
         7 . The device of  claim 6 , wherein said exit port is connected to internal springs connected to said internal plunger. 
     
     
         8 . The device of  claim 7 , wherein said device further comprise a microelectromechanical systems spring pressure regulator. 
     
     
         9 . The device of  claim 1 , wherein said device is made of bioerodible materials. 
     
     
         10 . The device of  claim 1 , wherein said device is made of microporous materials. 
     
     
         11 . The device of  claim 1 , wherein said device is made of nanoporous materials. 
     
     
         12 . The device of  claim 1 , wherein said device is made of medical grade materials. 
     
     
         13 . The device of  claim 1 , wherein said flow limiting port comprises at least one hole. 
     
     
         14 . The device of  claim 1 , wherein said flow limiting port comprises a filter. 
     
     
         15 . The device of  claim 1 , wherein said flow limiting port comprises at least one ePTFE membrane. 
     
     
         16 . The device of  claim 3 , wherein the flow of said fluid out of said device is gravity dependent. 
     
     
         17 . The device of  claim 3 , wherein the flow of said fluid out of said device is limited by a gravity dependent valve. 
     
     
         18 . A method of treatment, comprising:
 a) providing:
 i) a subject comprising lacrimal ducts and a lacrimal sac, 
 ii) a lacrimal system drug delivery device, comprising: 
   A) an elastic reservoir comprising a composition with at least one active ingredient, wherein said reservoir is capable of insertion inside said lacrimal sac,   B) a first tube with a lumen extending from said elastic reservoir through at least one of the lacrimal ducts, and   C) a second tube with a flow limiting port connected to said first tube, wherein said second tube terminates with said flow limiting port in a punctum in contact with the tear film of the eye,   b) inserting said drug delivery device into said lacrimal system; and   c) administering said composition to said subject using said lacrimal system drug delivery device.   
     
     
         19 . The method of  claim 18 , wherein said device further comprises an internal spring connected to an internal plunger connected to said exit port. 
     
     
         20 . The method of  claim 19 , wherein said internal plunger enables the constant release of said composition without relying on said elastic reservoir. 
     
     
         21 . The method of  claim 19 , wherein said device further comprises a microelectromechanical systems spring pressure regulator. 
     
     
         22 . The method of  claim 18 , wherein said device further comprises a third tube connected to said elastic reservoir, wherein said third tube extends from said elastic reservoir into the nasolacrimal duct wherein it terminates. 
     
     
         23 . The method of  claim 18 , wherein said device further comprises a cut-off valve. 
     
     
         24 . The method of  claim 18 , wherein said device comprises bioerodible materials. 
     
     
         25 . The method of  claim 24 , wherein said device comprises internal composition columns with said bioerodible materials. 
     
     
         26 . The method of  claim 25 , wherein the erosion of said bioerodible materials open up inlet pores sequentially allowing along said internal composition column which would enable for pulsed dosing of said composition. 
     
     
         27 . The method of  claim 18 , wherein said active ingredient consists of artificial tears, glaucoma drops, anti-inflammatory agents, nonsteroidal agents, antibiotics, biologics, proteins, aptamers, nucleic acids, cytokines, plasma, sympahtomemetics, parasympathomemetics, prostaglandin analogues, beta blockers, alpha-agonists, and anti-VEGF agents. 
     
     
         28 . The method of  claim 22 , wherein said elastic reservoir may be accessed through said third tube for the process of flushing and refilling. 
     
     
         29 . The method of  claim 23 , wherein the flow of said fluid out of said device is controlled by a cut-off valve that is accessible by an operator to decrease flow at given times when treatment is not desired. 
     
     
         30 . The method of  claim 18 , wherein said flow limiting port regulates the flow of said composition from said device. 
     
     
         31 . The method of  claim 18 , wherein said flow limiting port comprises at least one ePTFE membrane. 
     
     
         32 . The method of  claim 18 , wherein said flow limiting port comprises at least one layer of ePTFE material.