REFILL KIT FOR IMPLANTABLE PUMP
The invention relates to a kit for refilling an implantable pump and, more particularly, to packaging and contents of a kit to improve the workflow of a user while adding medication to an implantable pump that has been surgically implanted in a patient. kit for refilling an implanted pump. The kit comprises a setup tray containing at least one needle, a fenestrated drape, a first syringe, a needle, a filter, and clampable tubing; and a medication tray containing a second syringe, at least one ampule of medication, an ampule opener, and aspiration tubing. The medication tray is molded to have a recess that securely holds the at least one ampule in both a horizontal position and in a vertical position.
1 . A kit for refilling an implanted pump comprising:
a carton;
a first sealed tray contained in the carton, the first tray containing at least one needle, a fenestrated drape, a first syringe, a needle, a filter, and clampable tubing; and
a second sealed tray contained in the carton, the second tray containing a second syringe, at least one ampule of medication, an ampule opener, and aspiration tubing,
wherein the second sealed tray is molded to have a recess that securely holds the at least one ampule in both a horizontal position and in a vertical position.
2 . The kit of claim 1 , wherein the implanted pump is an intrathecal baclofen pump.
3 . The kit of claim 1 , wherein the at least one ampule of medication is a 5 ml ampule comprising 2000 mcg/ml baclofen.
4 . The kit of claim 1 , wherein the kit comprises two 5 ml ampules comprising 2000 mg/ml baclofen.
5 . The kit of claim 1 , wherein the kit comprises one 20 ml ampule comprising 2000 mcg/ml baclofen.
6 . The kit of claim 1 , wherein the at least one needle is a 22 gauge needle.
7 . The kit of claim 1 , wherein the first sealed tray comprises two needles.
8 . The kit of claim 7 , wherein the two needles are 22 gauge needles with 1.5 inch and 2 inch length.
9 . The kit of claim 1 , wherein the first and the second sealed trays are sealed with a polyethylene based film.
10 . The kit of claim 9 , wherein the polyethylene based film is compatible with commonly used sterilization methods selected from the group consisting of sterilization with ethylene oxide, gamma rays, and electron-beam.
11 . The kit of claim 9 , wherein the polyethylene based film is compatible to sterilization with ethylene dioxide.
12 . The kit of claim 1 , wherein the first tray and the second tray are sterilized after sealing such that the ampule, the first syringe, and the second syringe remain sterile during refilling of the implanted pump.
13 . A kit for refilling an implanted pump comprising:
a carton
a first sealed tray contained in the carton, the first tray containing at least one needle, a fenestrated drape, a first syringe, a filter, and clampable tubing; and
a second sealed tray contained in the carton, the second tray containing a second syringe, at least one ampule of medication, an ampule opener, and aspiration tubing,
wherein each of the first and the second sealed tray is sterilized after sealing.
14 . The kit of claim 13 , wherein the implanted pump is an intrathecal baclofen pump.
15 . The kit of claim 13 , wherein the first sealed tray comprises 2 needles.
16 . The kit of claim 15 , wherein the two needles are 22 gauge needles with 1.5 inch and 2 inch length.
17 . The kit of claim 13 , wherein the first and the second sealed trays are sealed with a polyethylene based film.
18 . The kit of claim 17 , wherein the polyethylene based film is compatible to sterilization with ethylene dioxide.
19 . A kit to facilitate easy, efficient, and sterile refilling of baclofen in an implantable intrathecal pump, the kit comprising a sealed setup tray comprising items for removing any residual baclofen from the pump, and a sealed medication tray comprising items for refilling the pump with fresh baclofen, wherein
the sealed setup tray comprises layers in the following order:
a) a first setup tray layer facing the user and comprising a topical antiseptic solution wipes and applicators,
b) a second setup tray layer positioned below the first setup tray layer and comprising sterile disposable gloves,
c) a third setup tray layer positioned below the second setup tra layer and comprising a fenestrated drape, and
d) a fourth setup tray layer positioned below the third setup tray layer and comprising a syringe, a needle, clampable tubing, and a sharps plug; and
the sealed medication tray comprises layers in the following order:
a) a first medication tray layer facing the user and comprising a syringe, prescribing information, and information for use,
b) a second medication tray layer positioned below the first medication tray layer and comprising at least gauze pad or a gauze roll,
c) a third medication tray layer positioned below the second medication tray layer and comprising at least one polybag, and
d) a fourth medication tray layer beneath the third medication tray layer comprising at least one gauze pad or a roll and a label,
e) a fifth medication tray layer positioned below the fourth layer and comprising medication ampule, aspiration tube, ampule opener, and a syringe cap.
wherein the setup tray and the medication trays are sterilized after sealing to keep the outer surface of the ampule and the syringes sterile during use, and
wherein the order of layers in the setup tray and the medication tray is based on requirement of supplies during each step of refilling the pump.