Abstract:
A punctum dilating and plug inserting system includes an inserter and a protective cover defining a dilator. The inserter includes a longitudinal body, and a handle. The handle has a rounded stationary member and a trigger rotatably connected to the handle by a living hinge. A mounting wire extends through the body and is connected to the trigger. When the trigger is activated, the wire is retracted and a plug mounted on a distal end of the wire is released. A packaging is provided for receiving, protecting, and handling at least a portion of the entire inserter until ready for use. An end of the packaging includes a dilator dip for dilating the punctum in advance of receiving the punctum plug.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates broadly to medical instruments. More specifically, this invention relates to instruments for inserting a punctum plug and a packaging for such instruments. 
     2. State of the Art 
     The surface of the eye and the inner surface of the eyelid are moisturized by tears constantly produced by glands around the eye. A tiny hole, known as the lacrimal punctum, at the inner corner of each upper and lower lid margin drains the tears away through ducts for proper circulation. 
     Patients, including contact lens wearers, who suffer from dry eye, or insufficient tear production, experience a great deal of discomfort because of insufficient lubrication between the lens and the surface of the eye. One solution is to occlude or block the lacrimal duct to prevent tear drainage. Permanent lacrimal occlusion can be performed surgically, typically by closing the punctal opening, whereas reversible occlusion can be performed by inserting a tiny plug into a portion of the lacrimal duct, such as the punctum. A typical punctum plug includes a cylindrical or frustoconical body, a larger head portion to retain the plug at the punctal opening, and a coaxial bore through the head portion and partially through the body at which the plug is coupled to the tip of an instrument during insertion. 
     A variety of instruments are available for inserting lacrimal occluders such as punctum plugs and canalicular implants. For example, Lacrimedics, Inc. of Rialto, Calif., has sold a canalicular implant preloaded on the tip of a wire stuck into a piece of foam. The wire is used to push the implant into the canaliculus. After the implant is deeply seated, the wire is withdrawn. 
     EagleVision, Inc. of Memphis, Tenn. sells the EP2 punctum plug inserter and dilator which is described in U.S. Pat. No. 5,741,292 to Mendius. This more complex device for punctal dilation and insertion includes a cylindrical body having a plug inserting tip at one end and an opposite punctum dilating end. An elongated button is arranged longitudinally along the body, and includes a slidable end and a fixed end positioned between the slidable end and the plug inserting tip. The button has an outwardly bowing inner surface spaced from the body such that when the button is pressed toward the body, the slidable end slides away from the plug inserting tip. A plug mounting wire is fixedly attached to the slidable end of the button, and slidably extends within the body and protrudes out of the plug inserting tip. A conventional punctum plug is attached to the protruding end of the wire. The mounting wire can be retracted by pressing on a button at a location between the proximal and distal ends of the mounting wire and thereby effect release of the plug. 
     In operation, one hand of the physician is placed against the face of a plug recipient, and the lid of the eye receiving the plug is pulled down to expose the punctal opening. The instrument is held in the other hand and the dilating tip is used to dilate the punctum. The instrument must then be turned around so that the plug inserting tip is now facing the eye, and the plug can then be inserted into the dilated punctum. It is noted that the device must be turned around carefully to prevent inadvertently dropping the instrument and to prevent unwanted contact with the plug (which may contaminate or dislodge the plug). Moreover, it must be turned around quickly, as the punctal opening begins to constrict within approximately five seconds after dilation. Once the plug is positioned in the punctum, the plug is released from the instrument by depressing the buttons, which retracts the wire and frees the plug. 
     FCI Ophthalmics of Marshfield Hills, Mass. sells a Ready-Set™ punctum plug system which also includes a plug inserter and punctal dilator instrument. The instrument is generally similar to the Mendius device, but includes a two-sided trigger with handles located on diametrically opposite sides of the body. When the handles are pressed toward a plug mounting pin and one another, the pin is retracted into the body, thereby dislodging the plug from the pin. 
     US Pub. No. 2004/0068286, also to Mendius, teaches a plug insertion instrument having a protective dilating cap covering the plug. The punctal opening can be dilated with the cap, and then the cap is removed to expose the plug at the same end as the dilator so that the plug can then be conveniently inserted into the punctum. The plug is deployed by pressing on a button attached to a proximal end of a plug mounting wire, with the plug mounted at the distal end of the wire. The button is pressed at a location between the proximal and distal ends of the wire to retract the wire and effect release of the plug. 
     SUMMARY OF THE INVENTION 
     In accord with the invention, a punctum dilating and plug inserting system includes an inserter and a protective cover defining a dilator. The inserter includes a longitudinal body defining a stable pathway therethrough and having a tapered tip, and a handle coupled to the body. The handle has a stationary member fixed relative to the body, and at most one trigger. The trigger is coupled to the body by a living hinge. A mounting wire extends through the body and has a distal end that extends beyond the tapered tip and a proximal end that is coupled to the trigger. The distal end of the mounting wire is adapted to receive a punctum plug. Movement of a free end of the trigger relative to the stationary member about the living hinge causes retraction of the wire relative to the longitudinal body to result in sufficient withdrawal of the wire into the body to result in release of the plug from the inserter. 
     In one aspect of a preferred embodiment, the stationary member of the handle is rounded with a diameter extending parallel to the axis of the mounting wire. In another aspect of a preferred embodiment, the longitudinal body extends substantially along a tangent to a circumference to the stationary member of the handle. In another aspect of the invention, the stationary member of the handle has concave sides to facilitate gripping by a user. The trigger preferably also includes a textured surface to facilitate manipulation. 
     In another preferred aspect of the invention, the living hinge is located spaced apart from the axis of the wire, and is fixed in location as the trigger is rotated. The stationary member defines a stop for the trigger. In accord with a preferred aspect of the invention, a leaf spring may be provided to return the trigger to a starting position for re-use of the inserter, should such be desired. 
     The cover is removably coupled over a portion of the instrument including the plug. In one embodiment, the cover is a cap friction fit over an end of the longitudinal body to enclose the punctum plug on the wire. The cap tapers to form a dilator sized to be inserted into the punctum to dilate the punctum. After the cap is used to perform dilation, the cap can be readily removed from the end of the body to expose the plug for insertion. In another embodiment, the cover is a packaging for receiving, protecting, and handling substantially the entire inserter until ready for use. The packaging is formed from a relatively rigid plastic and defines a body having that receives the inserter, and a distal end that tapers to the dilator. The cavity includes a dedicated portions that closely receive the longitudinal body of the inserter, the stationary member of the handle, and the trigger in a manner that prevents relative movement of such portions to each other while the inserter is retained within the packaging. The cavity also includes an enlarged area spaced about the distal end of the longitudinal body and the plug to prevent any contact therewith that could result in damage to or dislodgement of the plug from the inserter. In each embodiment, the cover structure defining the dilator provides a protective enclosure for a plug loaded on the mounting wire until the cover and inserter are decoupled. 
     The inserter of the invention may be operated by a physician as follows. In the embodiment in which the dilator is formed by a cap fit over the distal end of the longitudinal body, the physician holds the inserter in a first hand, and places a second hand on a cheek of the plug recipient and retracts the eyelid to expose the punctal opening. With the punctal opening exposed, the physician moves the dilator tip of the cap into the punctal opening, dilates the opening, and then withdraws the tip. Then, the cap is removed from the inserter, and the inserter is then again maneuvered to the punctal opening and the plug is inserted therein. In the embodiment in which the cover is in the form of a packaging in which the inserter is retained, the physician holds the packaging in a first hand, and places a second hand on a cheek of the plug recipient and retracts the eyelid to expose the punctal opening. With the punctal opening exposed, the physician moves the dilator tip of the packaging into the punctal opening, dilates the opening, and then withdraws the dilator tip. Then, the inserter is removed from the packaging and the inserter is advanced toward the punctal opening and the plug is inserted therein. 
     Once the plug has been inserted into the dilated punctal opening, the trigger is pressed so that it is rotated about the hinge, with the free end of the trigger rotated away from the axis of the mounting wire, to thereby withdraw the wire from the plug and release the plug into the punctum. After the plug has been released, the inserter and/or cover can be re-used. Where the inserter is provided with the leaf spring between the trigger and the stationary member of the handle, the inserter is particularly well adapted for a defined return of the trigger for re-use. 
     Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective assembly view of a punctum plug inserter and protective cap according to a first embodiment of the invention. 
         FIG. 2  is a longitudinal section view across line  2 - 2  in  FIG. 1 , shown without the punctum plug. 
         FIG. 3  is a perspective assembled view of the punctum plug inserter with protective cap according to the first embodiment of the invention. 
         FIG. 4  is a perspective assembly view of a punctum plug inserter and protective packaging according to a second embodiment of the invention. 
         FIG. 5  is a perspective assembled view of the punctum plug inserter with protective packaging according to the second embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring to  FIGS. 1 and 2 , a punctum plug inserting instrument  10  includes a longitudinally extending body  12 , and a handle  14  defining a stationary member  16  and a single rotatable trigger  18  integrally molded with the body  12  such that the body, the stationary member, and trigger are a unitarily construct. Such construct is preferably made of a polymeric material. 
     The longitudinal body  12  is preferably cylindrical, and has a preferably frustoconically tapered distal end  20  and a proximal end  22 . While the body is most preferably straight, it can alternatively include a curved distal portion to facilitate access to the punctum. A stable pathway is defined between its proximal and distal ends. The pathway can be defined by a bore, optionally with an inserted cannula. More preferably, the pathway (as shown) is defined by a series of alternating lateral slots  26 ,  28 ,  30  that extend along the length of the body to result in a pathway defined in size for stable retention and controlled longitudinal displacement of a mounting wire  32  positioned within the pathway. The mounting wire  32  has a distal end that extends sufficiently beyond the tapered tip  20  (at  34 ) to have a punctum plug  100  mounted thereon, and a bent proximal end portion  36  is coupled to the trigger  18 , preferably captured within a defined recess  38  in the trigger. Movement of the trigger  18  relative to the stationary member  16  causes retraction of the wire  32  relative to the longitudinal body  12  to result in sufficient withdrawal of the wire into the body to result in release of a plug  100  mounted on the inserter  10 . The trigger  18  is pressed at a location proximal of the proximal end portion  36  of the mounting wire to effect movement of the mounting wire  32  relative to the distal end of the body  12 . The trigger  18  preferably includes a textured surface, e.g., includes ribs  42 , at this location to facilitate stable manipulation thereof. 
     The stationary member  16  is stiff and substantially thicker than the longitudinal body  12  and includes concave sides  40 , both features to facilitate stable handling by a user. The stationary member  16  is preferably rounded, and more preferably defines a diameter D that extends parallel to the wire axis AW of the mounting wire  32 . The stationary member  16  is preferably laterally offset to one side of the longitudinal body  12 . In a preferred embodiment, the longitudinal body  12  extends substantially along a tangent to an outer circumference to the rounded stationary member  16  of the handle. The trigger  18  is preferably the same thickness as the stationary member and preferably extends as a continuation of the outer circumference. As such, the stationary member and the trigger together assume a substantial area of a closed rounded shape, such as a circle or oval. The trigger is substantially stiff and preferably not subject to deformation as it is rotated about the hinge axis. The trigger  18  includes a first end  43  and a free second end  45 . 
     The first end  43  of the trigger  18  is connected to the stationary member  16  by a living hinge  44  and is located adjacent the proximal end  22  of the longitudinal body  12 . The living hinge  44  is located spaced apart from the wire axis A of the wire  32 , and is fixed in location as the trigger  18  is rotated on its hinge axis AH relative to the stationary member  16 . The hinge axis AH is oriented orthogonal to the wire axis AW and is located at one side of said wire axis, whereas the trigger  18  can be pressed at a location situated along an opposite side of the wire axis AW to initiate rotation of the trigger about the hinge axis AH to move the second end  45  of the trigger  18  toward the stationary member  16 . 
     The stationary member  16  defines a stop  46  for the trigger  18 . More particularly, the lower surface  48  of the trigger and the upper face  50  of the stop  46  are angled relative to each other in the pre-actuated configuration (seen best in  FIG. 4  discussed below). As the trigger  18  is pressed, the lower surface  48  of the trigger is rotated into substantially planar contact against the upper stop face  50  to provide a positive indication that the mounting wire has been fully retracted. In accord with another aspect of the invention, turning to  FIG. 3 , a metal leaf spring  52  optionally may be provided between the trigger  18  and the stationary member  16 , preferably retained along the lower surface  48  and upper stop face  50 , to cause automatic to return of the trigger  18  to a starting position in which the distal end of the mounting wire  32  extends from the distal end of the body  12 . The leaf spring  52  particularly adapts the inserter  10  for re-use, should such be desired, as it provides consistency and repeatability to the hinge and trigger action for multiple uses. 
     Referring to  FIG. 3 , the stationary member  16  optionally may be formed with mating structure for detachably coupling a plurality of inserters  10  in a side-by-side arrangement. Female mating structure  56  is provided at one side of the stationary member  16 , whereas male mating structure (not shown) is provided at the opposite side. The mating structure may include an interference fit or snap fit that permits ready release of coupled inserters, but provides a sufficient number of inserters together as needed for an individual patient procedure. 
     In accord with a preferred aspect of the invention, a distinct cover structure incorporating a dilator is removably coupled to a portion of the inserter  10 , and covers the plug  100  mounted on the mounting wire  34 . Referring now to  FIGS. 2 and 3 , in one embodiment, the cover structure is a cap  60  that can be friction fit over a distal portion of the body  12 . Other means of coupling the cap to the inserter may be used, including threads and a releasable interlock. The cap  60  may include longitudinal slits  62  about which the cap resiliently expands to receive and capture and the body for retention thereon. The cap  60  tapers to form a dilator  64  preferably in the form of a substantially conical tip that is sized to be inserted into the punctum to dilate the punctum. The cap can be readily removed from the distal portion of the body to expose the plug for insertion. 
     The system of the invention may be operated by a physician as follows. The physician holds the inserter  10  in a first hand, and places a second hand on a cheek of the plug recipient and retracts the eyelid to expose the punctal opening. With the punctal opening exposed, the physician moves the dilator  64  of the cap  60  into the punctal opening, dilates the opening, and then withdraws the dilator from the opening. The cap  60  is then removed from over the distal end of the inserter  10 , and the inserter is then again maneuvered to the dilated punctal opening and the plug is inserted therein. The trigger  18  is then pressed so that it is rotated about the living hinge  44 , with the free end  45  of the trigger  18  rotated away from the axis A of the mounting wire  32 , to thereby withdraw the wire from the plug  100  and release the plug into the punctum. After the plug  100  has been released, the inserter  10  and/or cap  60  can be re-used. Where the inserter  10  is provided with the leaf spring  52  between the trigger  18  and the stationary member  16  of the handle, the inserter is particularly well adapted for a defined return of the trigger for re-use. 
     The procedure is repeated for the insertion of each punctum plug  100 , optionally with a different inserter  10  and cap  60  for each punctum. However, it is within the scope of the invention that the inserter  10  be reloaded by a user with plugs from a store of plugs so that the inserter can be used on more than one punctum of a patient and that the cap be repositioned over the distal portion of the inserter in preparation for subsequent use, even on the same patient. Before use on a different patient it is necessary to re-sterilize the inserter and cap. 
     Turning now to  FIGS. 4 and 5 , an alternative cover structure  160  incorporating a dilator  164  can be coupled to a portion of the inserter  10  to define a packaged inserter system  199 . The cover structure  160  is a rigid packaging in which the instrument  10  is protectively received and retained until ready for use. The packaging is formed from a relatively rigid polymer and defines a body portion  166  having a single open cavity  168  in the side  170  thereof shaped and otherwise adapted to receive the inserter  10 , an upper external finger grip  172 , and a lower finger grip  174  on the side  170  of the body portion  166  defining the cavity  168 . More particularly, the cavity  168  has a portions that closely receive the longitudinal body  12  of the inserter, and the distal and proximal sides  176 ,  178  of the stationary member  16  of the handle. Specifically, the distal and proximal sides  176 ,  178  of the stationary member  16  of the handle may be engaged by ribs  180 ,  182  defined within the cavity that facilitate an interference with the inserter. The cavity  168  is further shaped to retain the trigger  18  in a pre-actuation configuration, with the positive space  184  between the trigger  18  and stationary member  16  having sufficiently close tolerance to prevents movement of such portions relative to each other while the inserter  10  is retained within the cover structure  160 . The cavity  168  also includes an enlarged area  186  spaced about the distal end  20  of the longitudinal body  12  and the plug  100 . The enlargement minimizes the opportunity for any contact between the plug and the cover structure  160  during insertion and removal of the inserter  10  relative to the cover structure  160  that could otherwise result in damage to or dislodgement of the plug  100  from the inserter  10 . A lower portion  188  of the stationary member  16  extends out of the bottom of the cavity  190  to facilitate removal of the inserter from the cover structure  160 ; i.e., so that the stationary member  16  can be gripped to pull the inserter up and out of the cover structure. The cover structure  160 , at a distal end  192  (distal of the cavity  168 ) defines the dilator  164  in the form of a tapered nose portion sized to be inserted into and dilate the punctal opening. 
     The inserter  10  of the invention may be operated by a physician as follows. The physician holds the inserter  10  in a first hand, and places a second hand on a cheek of the plug recipient and retracts the eyelid to expose the punctal opening. With the punctal opening exposed, the physician moves the dilator  164  of the packaging  160  into the punctal opening, dilates the opening, and then withdraws the dilator from the opening. The inserter  10  is then removed from within the packaging  160  by lifting the lower portion  188  of the stationary member  16  of the handle  14  relative to the body  166  of the packaging. The inserter  10  is then used as described above, with each of the inserter and packaging  160  being capable of re-sterilization and re-usable. 
     In either embodiment, the distinct cover defining the dilator provides a protective enclosure for a plug loaded on the mounting wire until the protective structure and the inserter are decoupled, with the cover of the second embodiment further preventing actuation of the inserter until the cover is removed and further providing a body for manipulation of the dilator. 
     There have been described and illustrated herein embodiments of a punctum plug inserter and protecting cover therefor, as well as method of using the same. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.