Lacrimal implants and related methods

Abstract

Lacrimal implants and related methods providing secure retention within the lacrimal punctum of an eye are described. The lacrimal implants can comprise a implant body configured for at least partial insertion through the lacrimal punctum and into a lacrimal canaliculus. The implant body can include a deformable retention structure that can be configured to substantially encapsulate an expandable retention element. In some examples, the expandable retention element can include a fluid absorbing material, which can be exposed to fluid such as via a fluid permeable retainer or a fluid permeable aperture. As the fluid absorbing material retains fluid (i.e., upon acceptance of fluid into the retention structure), its size increases and its shape can change to urge one or more portions of the retention structure outward, such as against a wall of the lacrimal canaliculus, thereby securely retaining the lacrimal implant within the punctum.

1 - 31 . (canceled) 
     
     
         32 . A method of manufacturing a lacrimal implant insertable into a lacrimal punctum, the method comprising:
 forming an implant body including a retention structure, including forming a fluid permeable retainer through a portion of the retention structure;   substantially encapsulating a hydrogel retention element using the retention structure, the hydrogel retention element configured to expand when the retention structure is in a lacrimal canaliculus; and   wherein forming the fluid permeable retainer includes forming a structure allowing fluid permeation into the retention structure, and which further inhibits the hydrogel retention element during expansion from protruding out of the retention structure.   
     
     
         33 . The method of  claim 32 , wherein substantially encapsulating the hydrogel retention element includes disposing the hydrogel retention element in at least one chamber of the retention structure. 
     
     
         34 . The method of  claim 32 , wherein substantially encapsulating the hydrogel retention element includes confining the hydrogel retention element within an outer surface boundary of the implant body. 
     
     
         35 . The method  claim 32 , wherein forming the fluid permeable retainer includes forming a fluid permeable aperture, the aperture having a size and shape inhibiting escape of the hydrogel retention element from the retention structure. 
     
     
         36 . The method of  claim 32 , wherein forming the fluid permeable retainer includes forming a fluid permeable or hydrophilic cap member couplable to a distal end portion of the implant body. 
     
     
         37 . The method of  claim 36 , wherein forming the fluid permeable or hydrophilic cap member includes combining at least about 50 wt. % silicone with at least one of a contact lens material, sodium chloride, polyethylene oxide, polyethylene glycol, polyvinyl pyrilidone, or polyvinyl alcohol. 
     
     
         38 . The method of  claim 32 , wherein forming the fluid permeable retainer includes forming a fluid permeable or hydrophilic implant body portion. 
     
     
         39 . The method of  claim 38 , wherein the fluid permeable or hydrophilic implant body portion includes at least about 50 wt. % silicone in combination with at least one of a contact lens material, sodium chloride, polyethylene oxide, polyethylene glycol, polyvinyl pyrilidone, or polyvinyl alcohol. 
     
     
         40 . The method of  claim 32 , wherein forming the implant body includes injection molding a first implant body portion using a non-permeable, non-hydrophilic elastic material and injection molding a second implant body portion using a fluid permeable or hydrophilic elastic material. 
     
     
         41 . The method of  claim 32 , wherein forming the implant body includes molding a implant body projection having a diametrical size greater than a size of the punctum and having a convex proximal end portion. 
     
     
         42 . The method of  claim 32 , comprising disposing a drug core in a proximal end portion of the implant body, including positioning the drug core to provide release of the drug via a drug elution port. 
     
     
         43 . The method of  claim 32 , wherein forming the implant body includes molding a implant body septum between the drug core and the retention structure. 
     
     
         44 . The method of  claim 32 , comprising forming the expandable hydrogel retention element, including forming a hydrogel retention element configured to expand to the retaining size and shape in a time period of about 1 minute to about 60 minutes. 
     
     
         45 . The method of  claim 32 , comprising surface treating an outer surface portion of the implant body for adhesion of a fluid swellable material thereto. 
     
     
         46 . The method of  claim 45 , wherein surface treating the outer surface portion of the implant body includes plasma treating the implant body portion. 
     
     
         47 . The method of  claim 45 , comprising coating an outer surface portion of the implant body with the fluid swellable material. 
     
     
         48 . The method of  claim 32 , comprising pre-stressing a portion of the implant body to direct expansion of the hydrogel retention element. 
     
     
         49 . The method of  claim 48 , wherein the pre-stressed portion of the implant body directs expansion of the hydrogel retention element substantially perpendicular to an axis of the implant body. 
     
     
         50 . The method of  claim 32 , comprising controlling an amount of swelling of the hydrogel retention element, including varying the ratio of hydrogel to the ratio of polyurethane or silicone. 
     
     
         51 . A method of manufacturing a lacrimal implant insertable into a lacrimal punctum, the method comprising:
 forming an implant body including a retention structure, including forming a fluid permeable retainer through a portion of the retention structure;   disposing a drug core in a proximal end portion of the implant body, including positioning the drug core to provide release of the drug via a drug elution port;   substantially encapsulating a hydrogel retention element using the retention structure, the hydrogel retention element configured to expand when the retention structure is in a lacrimal canaliculus; and   wherein forming the fluid permeable retainer includes forming a structure allowing fluid permeation into the retention structure, and which further inhibits the hydrogel retention element during expansion from protruding out of the retention structure.