Multi-stage end-to-end cytotoxin handling system
First Claim
1. An integrated multi-stage end-to-end drug handling system comprising:
- a first stage for receiving a drug and for preparation of a dose of the drug;
a second stage in selective communication with the first stage for further processing the prepared dose; and
a third stage in selective communication with the second stage for further processing of the prepared dose, the third stage including an automated apparatus for sealing an item in an enclosure, wherein the third stage comprises a framed enclosure that has an exit port and the automated apparatus includes a flexible packaging sleeve that is in communication with the exit port and is supported by a sleeve body that has a removable top cover, the exit port permitting the item to be delivered to the packaging sleeve when the exit port is open to allow for creation of the enclosure to seal the item, wherein the third stage includes a docking assembly that permits the exit opening to be opened only when the sleeve body is in a locked position relative to a sleeve locking member that is part of the docking assembly and is coupled to the frame, the docking assembly further includes a docking ring cover that is configured to lock with the sleeve locking member to sealingly close the exit port, the docking ring cover further being configured to selectively lock with the top cover to permit removal from the sleeve locking member of the docking ring cover joined with the top cover resulting in the exit port being opened, whereby the sleeve body remains locked relative to the sleeve locking member;
wherein during the entire time from reception into the first stage for drug preparation thereof and to produce a dose to the sealing of the item in the enclosure, the drug remains in a controlled, sealed environment.
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Accused Products
Abstract
According to one embodiment, an integrated multi-stage end-to-end cytotoxin handling system includes a first stage for receiving a cytotoxin drug and for preparation of a dose of the cytotoxin drug; a second stage in selective communication with the first stage for further processing the prepared dose; and a third stage in selective communication with the second stage for further processing of the prepared dose. The third stage includes an automated apparatus for sealing the prepared dose in an enclosure. During the entire time from reception into the first stage for drug preparation thereof and to produce a cytotoxin dose to being scaled in the enclosure, the cytotoxin drug remains in a controlled, sealed environment.
28 Citations
28 Claims
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1. An integrated multi-stage end-to-end drug handling system comprising:
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a first stage for receiving a drug and for preparation of a dose of the drug; a second stage in selective communication with the first stage for further processing the prepared dose; and a third stage in selective communication with the second stage for further processing of the prepared dose, the third stage including an automated apparatus for sealing an item in an enclosure, wherein the third stage comprises a framed enclosure that has an exit port and the automated apparatus includes a flexible packaging sleeve that is in communication with the exit port and is supported by a sleeve body that has a removable top cover, the exit port permitting the item to be delivered to the packaging sleeve when the exit port is open to allow for creation of the enclosure to seal the item, wherein the third stage includes a docking assembly that permits the exit opening to be opened only when the sleeve body is in a locked position relative to a sleeve locking member that is part of the docking assembly and is coupled to the frame, the docking assembly further includes a docking ring cover that is configured to lock with the sleeve locking member to sealingly close the exit port, the docking ring cover further being configured to selectively lock with the top cover to permit removal from the sleeve locking member of the docking ring cover joined with the top cover resulting in the exit port being opened, whereby the sleeve body remains locked relative to the sleeve locking member; wherein during the entire time from reception into the first stage for drug preparation thereof and to produce a dose to the sealing of the item in the enclosure, the drug remains in a controlled, sealed environment.
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2. An integrated multi-stage end-to-end drug handling system comprising:
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a first stage for receiving a drug and for preparation of a dose of the cytotoxin drug; a second stage in selective communication with the first stage for further processing the prepared dose; and a third stage in selective communication with the second stage for further processing of the prepared dose, the third stage including an automated apparatus for sealing an item in an enclosure, wherein the automated apparatus includes a flexible packaging sleeve that is supported by a member and has a length that permits a plurality of individual successive enclosures to be generated, the packaging sleeve being in a furled condition and coupled to the support member such that the packaging sleeve can be unfurled to permit reception of the item and creation of one enclosure, the automated apparatus including a tensioner device that is disposed about an outer surface of the packaging sleeve to apply tension to the packaging sleeve and control the unfurling thereof from the support member; wherein during the entire time from reception into the first stage for drug preparation thereof and to produce a cytotoxin dose to the sealing of the item in the enclosure, the cytotoxin drug remains in a controlled, sealed environment. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 19, 20)
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12. An integrated multi-stage end-to-end cytotoxin handling system comprising:
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a first stage for receiving a cytotoxin drug and for preparation of a dose of the cytotoxin drug; a second stage in selective communication with the first stage for further processing the prepared dose; and a third stage in selective communication with the second stage for further processing of the prepared dose, the third stage including an automated apparatus for sealing an item in an enclosure; wherein during the entire time from reception into the first stage for drug preparation thereof and to produce a cytotoxin dose to the sealing of the item in the enclosure, the cytotoxin drug remains in a controlled, sealed environment;
wherein the automated apparatus for sealing the prepared dose comprises;a tubular sleeve having an open first end, an open second end, and an outer surface; a length of a flexible packaging sleeve that is open at one end, closed at an opposite end, and has an open interior space, the packaging sleeve being disposed about the outer surface of the tubular sleeve in a compressed form, the open end of the sleeve being sealingly attached to the first end of the tubular sleeve; and a tensioner device that is disposed about an outer surface of the packaging sleeve and includes a first section that couples the first end of the packaging sleeve to the tubular sleeve and a second section disposed over the compressed packaging sleeve such that the second section applies tension to the packaging sleeve and control the unfurling thereof from the tubular sleeve; wherein the open first end of the tubular sleeve is in communication with the open interior space of the packaging sleeve. - View Dependent Claims (13, 14, 15, 16, 17, 18)
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21. A method for preparing a dose of a drug and sealing it in an enclosure using an automated process comprises the steps of:
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introducing a drug into a first sealed chamber of a first stage; preparing a dose of medication in the first sealed chamber using an automated process; transferring the prepared dose of medication into a second sealed chamber of a second stage, the sealed chamber having glove ports with attached gloves to permit handling of the dose of medication; transferring the prepared dose of medication into a third sealed chamber of a third stage which includes an automated apparatus for sealing the prepared dose in an enclosure; and sealing the dose of medication in the enclosure and then acting on the enclosure so that it can be individually transported from the third stage to another location, while at the same time, the sealed environment of the third chamber is maintained; wherein during each of the transfers between the first stage and the second stage and the second stage and the third stage, the dose is contained within a sealed environment; wherein the step of sealing the dose of medication further includes the steps of; inserting the prepared medication into an open end of a tubular sleeve that has an outer surface, the open end being exposed to the first space, wherein a length of a flexible packaging sleeve that is open at one end and sealed at an opposite end and has an open interior space is disposed about the outer surface of the tubular sleeve in a compressed form, the open end of the sleeve being sealingly attached to the first end of the tubular sleeve such that the prepared medication is inserted into the open interior space; unfurling a predetermined length of the packaging sleeve from the tubular sleeve, the unfurling of the packaging sleeve being metered and controlled by a tensioner device that is disposed about an outer surface of the packaging sleeve and located exterior to the compressed packaging sleeve and applies tension to the packaging sleeve; and sealing the packaging sleeve along a seal. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28)
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Specification