Intraocular lens delivery system packaging
AssigneeJohnson & Johnson Surgical Vision, Inc.
InventorsYasemar Perez, Rodney Patch
Life of this patent
Estimating the term…
Abstract
Sterile packaging for an intraocular lens (IOL) delivery system includes a sealed container with an IOL delivery system contained therein, with a cap sealing the container. One or more tamper-evident solutions are provided on the packaging to ensure an indication of non-sterility. This configuration solves certain issues with prior packaging, such as clumsy transfers and bulky packaging which creates storage issues and mitigates sterility barrier risk associated with pouch or blister packaging or other non-rigid package types.
Claims24
A sterile package for an intraocular lens delivery system, comprising:
- an intraocular lens delivery system;
- a generally tubular container elongated along a central axis and having a closed distal end and a tubular open mouth at a proximal end, the open mouth being one end of a lumen defined by a wall of the tubular container that extends a first length in a distal direction;
- a proximal cap adapted to engage and seal the open mouth of the container, the cap having a gripping portion on a closed proximal end surrounding and spaced outwardly from a tubular skirt that projects in a distal direction, the tubular skirt having an inner cavity and an outer diameter which fits closely within the lumen of the container, the wall of the tubular container being dimensioned to contact and form a first seal with the cap;
- and
- a transfer tray configured to receive and retain the delivery system and form a subassembly therewith sized to fit within an inner cavity of the container, the transfer tray comprising a proximal handle sized to fit within the inner cavity of the tubular skirt of the cap and extend to the proximal end thereof,
- wherein the delivery system is sized to fit within an inner cavity of the container and a sterile condition is maintained by engaging the cap to the open mouth, and wherein a user may open the cap and deliver the delivery system to a sterile environment without touching the delivery system, and
- wherein the inner cavity of the cap comprises one or more radially-directed ribs on an inner surface configured to define a channel that receives and retains in an interference fit the proximal handle of the transfer tray.
A sterile package for an intraocular lens delivery system, comprising:
- an intraocular lens delivery system;
- a generally tubular container elongated along a central axis and having a closed distal end and a tubular open mouth at a proximal end, the open mouth extending a first length in a distal direction;
- a proximal cap adapted to engage and seal the open mouth of the container, the cap having a tubular gripping portion on a closed proximal end and a tubular skirt that projects therefrom in a distal direction, the tubular skirt having an outer diameter which fits closely within the open mouth of the container, and the cap having an inner cavity with a plurality of radially-directed ribs on an inner surface configured to define a channel;
- and
- a transfer tray configured to receive and retain an intraocular lens delivery system, the transfer tray having multiple shaped female recesses which match male shapes on the delivery system and at least one pair of retention wings which resiliently flex around and hold the delivery system in place on the transfer tray, the transfer tray further including a proximal handle which fits within a lumen of the tubular skirt of the cap and extends towards the proximal end thereof, the proximal handle being sized to be retained in an interference fit by the channel defined by the ribs within the cap,
- wherein a subassembly of the delivery system and transfer tray is sized to fit within an inner cavity of the container and maintain a sterile condition by engaging the cap to the open mouth, and wherein a user may open the cap and pull the subassembly from within the container and deliver the subassembly to a sterile environment without touching the subassembly.
A method of storing in a sterile condition and delivering to a sterile environment an intraocular lens delivery system, comprising:
- providing a sterile package enclosing an intraocular lens delivery system, sterile package including:
- a generally tubular container elongated along a central axis and having a closed distal end and a tubular open mouth at a proximal end, the open mouth extending a first length in a distal direction;
- a proximal cap adapted to engage and seal over the open mouth of the container, the cap defining an inner cavity;
- a transfer tray configured to receive and retain the delivery system, the transfer tray having multiple shaped female recesses which match male shapes on the delivery system and at least one pair of retention wings which resiliently flex around and hold the delivery system in place on the transfer tray, the transfer tray further including a proximal handle which fits within the inner cavity of the cap and extends towards the proximal end thereof;
- and
- at least one tamper-evident strip extending across a dividing line between the container and cap which must be broken to disengage the cap from the container, breaking the tamper-evident strip by rotating the cap;
- pulling a subassembly of the delivery system and transfer tray out of the container while only touching the cap;
- presenting the subassembly to personnel within a sterile environment;
- extracting the subassembly from the cap within the sterile environment;
- and separating the delivery system from the transfer tray prior to performing an ophthalmic surgical procedure.
A sterile package for an intraocular lens delivery system, comprising:
- an intraocular lens delivery system;
- a generally tubular container elongated along a central axis and having a closed distal end and a tubular open mouth at a proximal end, the open mouth being one end of a lumen defined by a wall of the tubular container that extends a first length in a distal direction;
- a proximal cap adapted to engage and seal the open mouth of the container, the cap having a gripping portion on a closed proximal end surrounding and spaced outwardly from a tubular skirt that projects in a distal direction, the tubular skirt having an inner cavity and an outer diameter which fits closely within the lumen of the container, the wall of the tubular container being dimensioned to contact and form a first seal with the cap;
- a first tamper-evident strip extending longitudinally over an entire length of the container and wrapping around the proximal end of the cap;
- a second tamper-evident strip;
- and
- a folded identification label secured to an exterior of the container and adapted to be pulled away from the container to view the identification thereon,
- wherein the second tamper-evident strip extends over the identification label, and the second tamper-evident strip must be removed or torn prior to viewing the identification on the identification label, and
- wherein the delivery system is sized to fit within an inner cavity of the container and a sterile condition is maintained by engaging the cap to the open mouth, and wherein a user may open the cap and deliver the delivery system to a sterile environment without touching the delivery system.
Dependencies are inferred from the claim text.