Patent Publication Number: US-7913475-B2

Title: Multi-stage end-to-end cytotoxin handling system

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application claims the benefit of U.S. patent application Ser. No. 61/109,739, filed Oct. 30, 2008, which is hereby incorporated by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present invention relates generally to a handling system that seals items individually so as to prevent operator exposure to the item and in particular, to medical and pharmaceutical equipment including a bag handling system that receives items, such as IV bags, syringes, etc., in a controlled environment and individually seals each item in a package (enclosure) while maintaining the sterile environment. 
     BACKGROUND 
     There are a vast amount of different types of drugs that come in different forms and are designed to treat a wide range of conditions and illnesses and diseases. One of the more deadly and unfortunately common diseases is cancer. Cancer is a class of diseases in which a group of cells displays uncontrolled growth, which is cell division beyond the normal limits; invasion, which is where cells intrude on and destroy adjacent tissues, and metastasis, which is where cells spread to other locations in the body via lympth or blood. Many cancers can be treated and even some can be cured, depending upon a number of factors, such as the type of cancer, the location and the stage of the cancer. Once diagnosed, cancer is usually treated with a combination of surgery, chemotherapy and radiotherapy. Chemotherapy is the treatment of cancer with drugs that can destroy cancer cells. 
     One class of chemotherapy drugs is antineoplastics, also known as cytotoxic antibiotics, which are drugs that inhibit and combat development of tumors. Cytotoxic drugs are toxic compounds that are known to have carcinogenic, mutagenic and/or teratogenic potential. With direct contact, these compounds can cause irritation to the skin, eyes, and mucous membranes and ulceration and necrosis of tissue. As a result of the high level of toxicity of these drugs, the exposure of health-care personnel to these drugs should be minimized. 
     During drug preparation, a variety of manipulations and handling tasks are performed which can result in aerosol generation, spraying, and splattering of the drug. Some of the more common manipulations include but are not limited to: the withdrawal of needles from drug vials, the use of syringes and needles for drug transfer or drug reconstitution, and the expulsion of air from the syringe when measuring the precise volume of a drug. The contamination may be a direct transfer of the drug to the body of the health-care provider or the exterior of the medical product, such as a syringe or IV bag can be contaminated with the drug and then later transferred by direct contact between a person and the contaminated exterior surface. 
     Pharmaceutical practice calls for the use of aseptic techniques and a sterile environment. Many pharmacies attempt to provide this sterile environment by using a horizontal laminar flow work bench. While this type of equipment provides some benefit, it suffers from a number of shortcomings, including that it can expose the operator and other health-care personnel or others in the same room to aerosols generated during drug preparation procedures. As a result of this concern, a Class 11 laminar flow (vertical) biological safety cabinet (with HEPA filter) that is designed to provide both product and operator protection is needed when dealing with and handling cytotoxic drugs. Syringes and unclipped needles can be disposed of by manually placing these items into leakproof containers. 
     The disposal of cytotoxic drugs and trace contaminated materials (e.g., gloves, gowns, needles, syringes, vials, etc.) presents a possible source of exposure to pharmacists, nurses, and physicians, as well as to other staff members, including the cleaning and janitorial staff. 
     The adverse health effects associated with antineoplastic agents (cancer chemotherapy drugs, cytotoxic drugs) in cancer patients and some non-cancer patients treated with these drugs are well-documented. The very nature of antineoplastic agents makes them harmful to healthy constantly dividing cells and tissues, as well as the cancerous cells. For cancer patients with a life-threatening disease, there is a great benefit to treatment with these agents. However, for the healthcare personnel that are exposed to antineoplastic agents as part of their work practice, precautions should be taken to eliminate or reduce exposure as much as possible. There already is a limitation in cytotoxics dissolution in Australia and the United States to 20 dissolutions per pharmacist/nurse, since pharmacists that prepare these drugs or nurses that may prepare and/or administer them are the two occupational groups with the highest potential exposure to antineoplastic agents. In addition, physicians and operating room personnel may also be exposed through the treatment of patients. Hospital staff, such as shipping and receiving personnel, custodial workers, laundry workers, and waste handlers, all have potential exposure to these drugs during the course of their work. The increased use of antineoplastic agents in veterinary oncology also puts these workers at risk for exposure to these drugs. 
     Since conventional methods for preparing and handling cytotoxin drugs are essentially very manual, labor intensive in nature, the operator performing these tasks is exposed to the hazardous side effects of the cytotoxin drugs. There is therefore a need for an improved, safer method and system for handling cytotoxin drugs particularly in drug preparation and drug transfer environments. 
     SUMMARY 
     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 sealed in the enclosure, the cytotoxin drug remains in a controlled, sealed environment. 
     The automated apparatus for sealing the prepared dose can include a tubular sleeve having an open first end, an open second end, and an outer surface; and 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 is disposed about the outer surface of the tubular sleeve in a compressed form. The open end of the sleeve is sealingly attached to the first end of the tubular sleeve. The apparatus also includes 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 at least two elongated tensioner arms that extend along a length of the tubular sleeve. The compressed packaging sleeve is disposed underneath the tensioner arms such that the tensioner arms apply tension to the packaging sleeve and control the unfurling thereof from the tubular sleeve. The open first end of the tubular sleeve is in communication with the open interior space of the packaging sleeve. 
     In another embodiment, a method for preparing a dose of a cytotoxin drug and sealing it in an enclosure using an automated process includes the steps of: introducing a cytotoxin drug into a first sealed chamber of a first stage and preparing a dose of medication in the first sealed chamber using an automated process. The method further includes the steps of transferring the prepared dose of medication into a second sealed chamber of a second stage. The sealed chamber has glove ports with attached gloves to permit handling of the dose of medication. The prepared dose of medication is then transferred into a third sealed chamber of a third stage which includes an automated apparatus for sealing the prepared dose in an enclosure. The dose of medication is sealed in the enclosure and the enclosure is acted on 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. 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. 
     These and other aspects, features and advantages shall be apparent from the accompanying Drawings and description of certain embodiments of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a front perspective view of a multi-stage end-to-end cytotoxin handling station according to a first embodiment of the invention; 
         FIG. 2  is a perspective view of a bag handling system for use in the handling station of  FIG. 1 ; 
         FIG. 3A  is a perspective view of a disposable packaging sleeve for use in the bag handling system of  FIG. 2  and shown prior to use; 
         FIG. 3B  is a perspective view of the sleeve of  FIG. 3A  with a protective outer packaging removed therefrom; 
         FIG. 4  is a perspective view of a docking ring cover and a top cover (cap) shown exploded from the sleeve; 
         FIG. 5  is a perspective view of the docking ring cover attached to the cap and exploded from the sleeve; 
         FIG. 6  is a perspective view of components of the bag handling system shown a heat sealer and cutter in retracted positions; 
         FIG. 7  is a perspective view of the bag handling system with a gripper device in a retracted position and the heat sealer in an intermediate position; 
         FIG. 8  is a perspective view of the bag handling system with a heat seal having been formed and the cutter in an intermediate position; 
         FIG. 9  is a perspective view of the bag handling system with a sealed enclosure being released into the collection bin and a next packaging sleeve being exposed for being extended; 
         FIG. 10  is a perspective view of a the components that form the packaging sleeve top cover; 
         FIG. 11  is a rear perspective view of the sleeve locking member; 
         FIG. 12  is a top exploded perspective view of the docking ring cover; 
         FIG. 13  is a rear exploded perspective view of the docking ring cover; and 
         FIG. 14  is a rear perspective view of the docking ring cover in a locked position with a back plate thereof being transparent to allow view of the inner components. 
     
    
    
     DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS OF THE INVENTION 
     A multi-stage end-to-end cytotoxin handling station  100  is illustrated in  FIG. 1  according to one exemplary embodiment. The station  100  is designed to perform a number of operations that generally relate to the drug processing and drug transfer fields and in particular, the station  100  is configured to receive drugs and equipment in a sealed environment, such as syringes, etc.; to process and prepare drug doses in a sealed environment; and to package drug products and/or dispose of medical waste in a sealed environment. 
     More specifically, the station  100  includes a first section  200  for receiving drugs and medical equipment, as well as performing drug preparation, a second section  300  for processing the drugs and preparing drug doses; and a third section  400  for further processing of the doses and for sealing the doses, as well as medical equipment, in sealed enclosures that can then be transported from the station  100  to a point of use. It will be understood and as set forth in greater detail hereinafter, the operations performed in each section are conducted in a sealed, sterile environment, thereby reducing the risk of personnel being exposed to the cytotoxin drug. 
     The first section  200  includes a housing  210  that defines an interior chamber  220  which has a bottom surface or floor onto which items, such as drug vials, syringes, IV bags, etc., can be placed. In the illustrated embodiment, the housing  210  is a hollow rectangular structure that is supported by a set of legs  212 . The interior chamber  220  is connected to a vacuum source so that the interior is maintained at a negative pressure. The housing  210  includes a means for delivering items into the interior chamber  220 . For example, the housing  210  can include a sealed doorway (not shown) or the like formed along a first wall  214  that is exposed and faces away from the second section  300 . The sealed doorway permits items to be placed into the negative pressure environment of the interior chamber  220 . 
     Typically, the items, such as drug vials, syringes, etc., that are placed in the interior chamber  220  are in sealed packaging. For example, a drug vial containing a cytotoxin drug, is typically scaled in protective plastic packaging so as to provide a barrier between the vial and the operator. Similarly, the medical equipment, such as syringes and the like, are sealed in packaging. Items that are needed to prepare a medication dose are thus introduced into the interior chamber  220 . 
     The first section  200  can include automated equipment that is used for drug preparation. For example, the automated equipment can include a robotic device that receives loaded items and transports them from one location to another location within the interior chamber  220 . The robotic device is configured so that it can receive any number of different sized and shaped items, including drug vials, syringes, IV bags, etc. The automated equipment can also include an automated drug preparation device that is configured to perform a number of drug preparation steps, including removal of a cap from the drug vial, reconstituting the medication, withdrawing (aspirating) the contents of the drug vial, etc. Applicants&#39; previous patents, e.g., U.S. Pat. Nos. 7,117,902; 6,915,823; 7,017,622, etc., generally describe certain components that can be utilized in the first section  220 . 
     In one embodiment, once the drug dose has been properly prepared in the first section  200 , it can be grouped with other drug doses and/or other medical equipment, and placed on a substrate, such as a tray or the like, thereby defining a kit that can be transported to a point of use location. 
     The first section  200  is in selective fluid communication with the second section  300  to allow the controlled movement of items from the first section  200  to the second section  300 . For example, an internal pass through or door  305  can be formed in the common wall between the first and second sections  200 ,  300  or within the adjacent walls of the first and second section  200 ,  300  that face one another. In the closed position, the first and second sections  200 ,  300  are scaled from one another. 
     The second section  300  is defined by a hollow body (rectangular or square shaped) that defines an interior chamber  310 . The second section  300  includes a bottom wall or floor  320  onto which items can be placed and can include a set of legs that support the bottom wall  320 . The illustrated section  300  also includes a pair of side walls  330  that are formed of a transparent material to allow an operator to view the inside (interior chamber  310 ) of the second section  300 . Opposite ends walls  340 ,  342  of the second section  300  face the first and third sections  200 ,  400 , respectively. The pass through or door  305  is formed in end wall  340 . 
     As with the first section  200 , the second section  300  is operatively coupled to a vacuum source and therefore, the interior chamber  310  thereof operates in vacuum conditions. This permits the operator to perform operations in the interior chamber  310  in a controlled environment. 
     The second section  300  also includes a plurality of sealed glove ports  360  formed in the side walls  330  to allow an operator to physically and manually manipulate (pickup, move, etc.) items that are present in the interior chamber  310 . For example, one side wall (the front of the second section  300 ) can include three glove ports  360 , while the other side wall (the back of the second section  300 ) can include two glove ports  360 . Gloves, such as thick rubber gloves are sealingly attached to the glove ports  360  to allow an operator to insert his or hand therein and touch items that are located in the interior chamber  310 . At least of the glove ports  360  and attached glove is located near the door  305  so that the operator can open the door  305  using the glove and retrieve items from the first section  200 . It will be appreciated that the glove ports  360  can be arranged at different heights within the interior chamber  310 . 
     It will be appreciated that while the drug processing steps that are undertaken in the second section (second stage)  300  can be done manually, the second section  300  can include an automated dose preparation system, such as the one indicated at  301 . The automated dose preparation system  301  can be similar to the ones disclosed in Applicant&#39;s patents listed and referenced herein. For example, the system  301  is a computer based system that allows the user to input instructions and a robotic device, such as the one shown at  303 , operates to retrieve the items from the first section  200  and then performs processing operations in the second section  300 . For example, the robotic device  303  can retrieve syringes, TV bags, or the like from the first section  200  and then further process these components in the second section before delivering the components to the third section  400  in an automated manner, while maintaining the controlled environment. 
     Similar to the interface between the first section  200  and the second section  300 , the second section  300  is in selective communication with the third section  400 . As with the first and second sections  200 ,  300 , the third section  400  is a hollow body that has an interior chamber  410  and a set of legs which support the body. As with the first and second sections  200 ,  300 , the third section  400  is operatively connected to a vacuum source and therefore, the interior chamber  410  is under negative pressure. 
     One end of the third section  400  faces the second section  300 , while an opposite end defines an exposed end  402 . The third section  400  also includes side walls  404 . There can be a common wall between the second section  300  and the third section  400  or the sections can have respective walls that abut one another. 
     An internal pass through or door  405  provides selective communication between interior chamber  310  and interior chamber  410  and in the illustrated embodiment, the door  405  is located outside of the interior chamber  410 . For example, a manifold  420  or the like is sealingly coupled to the door  405  at one end  422 , while an opposite end  424  is sealingly coupled to one side wall  404 . The door  405  thus sealingly closes off the manifold  420  to the interior chamber  310  and vice versa. At the end  424 , a pivotable flap (rubber flap) (not shown) is provided to cover the opening formed in the side wall  404 . In a rest position, the flap is in the closed position and closes off the manifold  420  from the interior chamber  410 . In addition, the manifold  420  includes an exterior door (not shown) that is formed along one side wall thereof between the ends  422 ,  424 . The door sealingly closes with respect to the manifold  420  to maintain the interior of the manifold  420  as a controlled environment under negative pressure. However, when opened, the door permit the operator to retrieve items located in the interior of the manifold  420 . 
     The manifold  420  permits items, such as prepared doses, to be passed from the second section  300  to the third section  400  in a sterile, controlled environment. Exposed end  402  can be a transparent wall and includes a pair of glove ports  360  to permit the operator to manipulate items that are contained within the interior chamber  410 . One of the glove ports  360  is located proximate the flap to allow the operator to have access to the interior of the manifold. 
     In contrast to the first and second sections  200 ,  300 , the third section  400  does not include a bottom wall or floor but instead is open at least in several different locations (e.g., one or more rectangular openings). The opening(s) is designed to receive the bag handling system  500  that is illustrated in  FIG. 2 . As described below in detail, the bag handling system  500  is configured to receive an item in the sealed, controlled environment of the interior chamber  410  and allow each item to the sealingly closed in an individual enclosure in an least partially automated manner. 
     The bag handling system  500  can be a portable system and therefore, can include wheels  502  to permit the system  500  to be easily moved from one location to another location. The system  500  is defined by a frame  510  (e.g., a cart shaped frame). The frame  510  has an open top portion  512  that supports a substrate (countertop)  520 . As illustrated, one exemplary frame  510  is open along the top  512  and along one side (a front)  514 , while it is closed along the other side (rear) and the ends. The substrate  520  includes an opening  522  that allows part of the handling system  500  to pass through as described below. For example, the opening  522  can be a circular shaped opening. When installed in the third section  400 , the substrate  520  is supported by the frame  510 . 
     It will also be appreciated that the system is capable of maintaining an aseptic environment and is capable of allowing waste removal in a controlled manner individually from each stage without breaching containment barriers. 
     The system  500  includes an automated bag sealing mechanism  600  that receives the items to be sealed in an enclosure and operates on the same to seal each item in an enclosure which is then delivered to a location, such as a bin, where it can be collected and then moved to another location, such as a point of use. Before describing in detail the bag sealing mechanism  600 , a discussion of a disposable packaging sleeve  700  for use in the bag sealing mechanism is in order.  FIG. 3A  shows the packaging sleeve  700  contained within a sealed protective package  702  prior to its use and insertion into the mechanism  600 . The protective package  702  protects the packaging sleeve  700  after its assembly, during storage and during transportation to a customer. The protective package  702  can be formed of a plastic sheet material that encloses the sleeve  700  and is sealed along all peripheral edges (sides and ends) thereof. When the customer is ready to use the sleeve  700 , the customer simply removes the package  702  from the sleeve  700 . For example and according to one embodiment, the package  702  can be an outside heat sealed bag that ensures that the package  702  is clean. 
       FIG. 3B  shows the sleeve  700  with the outer packaging  702  having been removed. The sleeve  700  is formed of a number of different components and in particular, the sleeve  700  includes a sleeve body  710  that is a hollow elongated structure (e.g., a tube) that has an open first end  712  and an opposing open second end  714 . The body  710  has an outer surface  716  and an opposing inner surface  718 . At the open first end  712 , at least one and preferably a plurality of locking tabs  720  are provided. The locking tabs  720  extend radially outward from the first end  712  and are formed circumferentially about the first end  712 . As shown, there can be more than one type of locking tabs  720 . The illustrated locking tabs  720  include two different types of locking tabs, namely, a small rectangular shaped locking tab and a large rectangular shaped locking tab. 
     Now referring to  FIGS. 2-5  and  10 , the sleeve  700  also includes a top removable cover  730  that is configured to lockingly engage and mate with the sleeve body  710  so as to seal the first end  712  thereof. As best shown in the exploded view of  FIG. 4 , the cover  730  is constructed to sealingly close off the first end  712  when it is inserted and locked to the first end  712 . The illustrated cover  730  is a disk shaped member that has an inner surface that faces the interior chamber of the sleeve  700  when the cover  730  lockingly engages the sleeve body  710  and an opposite outer surface  734  that faces outward from the sleeve  710 . The cover  730  also includes a peripheral side edge  735  that can include a seal element  701  (such as an O-ring) to allow the cover  730  to seal relative to the inner surface of the cover  730 . The seal element  739  can be thought of as an upper seal due to its position closer toward the outer surface  734 . 
     The peripheral side edge  735  also includes locking means for selectively locking the cover  730  to the sleeve body  710 . For example, the side edge  735  can include a locking pin assembly that includes a locking pin  737  that extends radially outward therefrom through an opening that is formed in the peripheral side edge  735 . The pin(s)  737  is configured to be received into a locking slot or channel  739  that is formed in the inner surface  718  of the sleeve body  710 . The locking pin assembly also includes a biasing member (spring  740 ) that applies a biasing force to the pin  737  to cause the pin  737  to be extended into the locking channel  739  when the cover  730  is locked in place relative to the sleeve body  710 . The cover  730  also includes a locking cam pin  742  that is received in a bore that is open along the outer surface  734 . In particular, in the center of the cover  730  includes a bore that receives the cam pin  742  and intersects the bore that contains the pin  737  and biasing member  740 . One end of the cam pin  742  is designed to engage and be coupled to the pin  737 . Manipulation of the cam pin  742  causes the release of the pin  737  in that by manipulating the cam pin  742 , the pin  737  can be placed in an unlock position which permits the biasing member  740  to release it energy. This results in the pin  737  being extended into the aligned locking channel  739  when the cover  730  is locked relative to the sleeve body  710 . 
     The locking channel  739  has a first section (vertical section) that is formed along a length of the sleeve body  710  and a second section (horizontal section) that intersects the first section at one end thereof. The first and second channel sections thus generally are in an “L” shape. To lock the cover  730  to the sleeve body  710 , the pins  737  are inserted into the locking channel  739  and by rotating the cover  730 , the pins  737  are moved into a locking position in the channel  739  that prevents the cover  730  from being removed. 
     The outer surface  734  of the cover  730  includes locating and coupling members  732  that serve to couple the cover  730  to another member as described below. The coupling members  732  can be in the form of a plurality of circular shaped protrusions or upright posts that are spaced across and located in different locations. The protrusion  732  can have sections with varying diameters and in particular, a top (distal end) of the protrusion  732  can be in the form of a flange that has a greater diameter than a bottom portion. 
     In the locked position, the upper surface of the cover  730  is generally flush with the top edge (first end  712 ) of the sleeve body  710 . The locking members  732  extend beyond the first end  712  of the sleeve body  710 . 
     The sleeve  700  is designed to hold a length of a bag  750 , such as a plastic bag, that receives an item and is sealed, as described below, at select locations resulting in the item being sealingly contained within the plastic bag. The bag  750  has a complementary shape to the sleeve body  710  and in particular, the bag  750  can be a tubular shaped bag. In one embodiment, about 14 to 20 feet of bag material is compressed and stored along the outer surface  716  of the body  710 . For example, the bag material can be gathered and compressed linearly along the sleeve body  710 , thereby along a large length of bag material to be stored along a much smaller length body  710 . The bag material is typically a plastic material that has a selected, suitable thickness to allow items to be securely contained therein in a sealed manner. Typically, the bag material is transparent to allow viewing of the sealed item and allow any identifying indicia to be viewable. 
     The sleeve  700  also includes a bag holding element (bag tensioner)  760  that not only securely attaches one end of the bag  750  to the sleeve body  710  but also tensions the compressed bag  750  so as to meter bow much bag material  750  is dispensed at one time (e.g., one pulling motion). Any number of different devices or mechanisms can serve as the bag tensioner  760  so long as they perform the intended function described herein. 
     For example and according to one embodiment, the bag tensioner  760  includes a top sealing ring  762  and a pair of elongated tensioning arms  764  that are each attached at one end to the top sealing ring  762 . Due to the tubular, cylindrical shape of the sleeve body  710 , the top sealing ring  762  has a circular shape (annular shape). When installed, the top sealing ring  762  is positioned proximate to or in an abutting relationship with the undersides of the locking tabs  720  at the first end  712 . The bag  750  is thus positioned underneath the top sealing ring  762  against the sleeve body  710 . The top sealing ring  762  thus sealingly attaches one end of the bag  500  to the outer surface of the sleeve body  710  near the first end  712 . In effect, the bag  500  is pinched and sealed in place along the outer surface of the sleeve body  710 . Various sealing techniques, including heat seals, can be used to seal the end of the bag  750  to the outer surface of the body  710 . 
     In addition, it will be appreciated that the top sealing ring  762  can be formed as two parts that can be interlockingly attached to one another. Thus, the bag  750  can first be disposed about the outer surface of the sleeve body  710  and gathered (compressed) therealong and then the two parts of the ring  762  are disposed over the end of the bag  750  and are interlockingly engaged with one another. 
     The arms  764  are typically located opposite one another (180 degrees apart); however, the arms  764  can be disposed at other angles relative to one another. The length of the arms  764  is selected so that when the tensioner  760  is fully installed on the body  710 , distal ends  765  of the arms  764  are proximate the open second end  714  of the sleeve body  710 . It will be appreciated that the bag  750  in its compressed form is disposed underneath the arms  764 . The arms  764  are thus tensioning elements that hold and maintain the compressed (gathered) bag  750  along the outer surface of the sleeve body  710 . Accordingly, the arms  764  have some flexing action to accommodate the gathered bag  750 ; however, the natural biasing action of the arms  764  applies tension to the bag  750  such that when the exposed end of the bag  750  is pulled away from sleeve body  710 , the bag  710  is slowly released from the second end  714  of the sleeve body  710 . 
     The bag  750  can be provided with one end already sealed (e.g., a heat seal) and therefore, the placement of the bag  750  onto the sleeve body  710  only requires the opposite open end of the bag  750  to be disposed about the outer surface of the sleeve body  710  and then brought into position at the first end  712  of the sleeve body  710  where it is fixedly attached to the sleeve body  710 . The insertion of the bag  750  onto the outer surface of the sleeve body  710  results in the second end  714  of the sleeve body  710  being closed. 
     In another embodiment, the bag tensioner  760  can be in the form of another sleeve which contacts the underlying bag and applies the necessary tension (force) to the bag so as to provide the desired metering of the bag. 
     The sleeve  700  includes a sleeve locking member  800  that selectively is placed in engagement with the sleeve body  710 . As shown in  FIG. 2 , the sleeve locking member  800  is coupled to the substrate  520  and in particular, the sleeve locking member  800  is axially aligned with the opening  522  such that the interior bore formed therein is in registration with the opening  522 . This permits an item that is inserted into the sleeve locking member  800  to pass directly into the sleeve body  710 . As shown in  FIG. 2 , a spacer  801  can support the sleeve locking member  800  and space it from the top surface of the substrate  520 . The spacer  801  can have an angled top surface which results in the sleeve locking member  800  being supported at an angle as illustrated. The spacer  801  can thus be a wedge shaped member that is inserted between the sleeve locking member  800  and the upper surface of the substrate  520 . 
     The spacer  801  is an annular shaped member that is attached to the top surface of the substrate  520  with the central opening of the spacer  801  being axially aligned with the opening  522  to allow the item to pass through the sleeve locking member  800 , the spacer  801  and then into the sleeve body  710 . When the sleeve body  710  is attached to the sleeve locking member  800 , the sleeve body  710  is in a vertical position with a majority of the sleeve body  710  being located below the substrate  520 . The sealed second end  751  of the bag  750  (disposable packaging sleeve) is thus located below the substrate  520 . 
     The sleeve locking member  800  is an annular member that includes a top edge  810  and an opposite bottom edge  812 . The locking member  800  includes an inner surface. As shown in  FIG. 4 , the locking member  800  can include two different parts, namely, a first part  820  and a second part  830 . The first part  820  has a thinner construction than the second part  830  and therefore, a shoulder  832  is formed (e.g., a right angle shoulder). The first part  820  defines the top edge  810  and on an outer surface of the first part  820 , a locking channel  822  is formed. The locking channel  822  is open along the top edge  810  and similar to the locking channel  739 , the locking channel  822  is defined by two sections, namely, a first vertical section that is open along the top edge  810  and a second horizontal section that intersects and is open to the first section at the opposite end of the first section. 
     The sleeve locking member  800  includes locking features that are complementary to the locking tabs  720  to allow the sleeve locking member  800  to interlockingly engage the first end  712  of the sleeve body  710  as shown in  FIG. 5 . The inner diameter of the first part  820  is about equal to the inner diameter of the sleeve body  710  so that a smooth, substantially continuous inner surface results when the sleeve locking member  800  is securely attached to the sleeve body  710 . 
     As shown in  FIG. 11 , the sleeve locking member  800  includes a bottom surface  801  and a bottom track (annular ring)  803  that provides a surface to which the top of the cover  730  seats against. The track  803  includes a number of cutouts that permit a degree of rotation of the locking tabs  720 . Within the cutouts and circumferentially spaced along the track  803  a plurality of through holes or bore are formed for receiving a plurality of locking mechanisms. For example, the locking mechanism can include a plurality of first locking mechanism  860  for selectively locking the sleeve locking member  800  to the sleeve body  810  and a second locking mechanism  870  for selectively locking the sleeve locking member  800  to another member as described below. Each of the locking mechanisms  860 ,  870  includes a pivot pin  880  to permit movement thereof between an unlocked position and a locked position. The pivot pin  880  is received within a bore that is formed along an outer surface of the circumferential side of the member  800  and is operatively coupled to the respective locking mechanism. It will be appreciated that the locking mechanisms can be exposed along different surfaces of the member  800 . For example, the first locking mechanism  860  can be accessible along a bottom face (surface) of the member  800 , while the second locking mechanism  870  can be accessible along a top face (surface) of the member  800 . In one embodiment, each locking mechanism includes a protrusion or post that protrudes outwardly from the respect top or bottom face of the member  800  and into engagement with a complementary locking feature to cause a coupling between the member  800  and the other member. 
     Each of the locking mechanisms  860 ,  870  can include a biasing element (spring)  861  that intimately and operatively are coupled to an internal locking assembly seal  863 . 
     As described below, to lock the sleeve body  710  to the member  800 , the first end of the sleeve body  710  is mated with the track  803  such that the locking tabs  720  are received into the cutouts formed along the track  803 . 
     The sleeve  700  also includes a docking ring cover  900 . The docking ring cover  900  is complementary to both the sleeve locking member  800  and the cover  730 . The docking ring cover  900  includes a bottom surface  902  and an opposite top surface  904 . The top surface  904  is designed as an area that can be grasped by the operator to allow the cover  900  to be picked up, etc. 
     As best shown in  FIGS. 12 and 13 , the docking ring cover  900  is actually formed of a number of parts that cooperate with one another. For example, the cover  900  includes a rotatable inner knob member  910 , a main cover  920  and a back plate  950 , as well as a number of seal elements (e.g., a first seal  945 , a second seal  947 , and a third seal  949 ). The inner knob member  910  is rotatable relative to the main cover  920  and the back plate  950 . In the illustrated embodiment, the top surface  904  has a pair of recessed sections to allow insertion of the fingers of an operator and to permit the inner knob member  910  to be grasped and rotated relative to the main cover  920 . The main cover  920  is a disk shaped member that includes a hollow interior cavity or compartment and has a central recessed section  923  that defines a floor and includes an opening  925  passing therethrough. The recessed section  923  includes an annular groove that receives the first seal  945 . The first seal  945  is thus a seal ring for the inner knob member  910 . A portion of the inner knob member  910  is received within the opening  925  of the floor  923  and is rotatable therein and therefore, the inner knob member  910  is also disk shaped. 
     The two recessed sections are defined in part by a pair of inward protrusions  921  that extends radially inward toward one another. The two protrusions  921  are located about 180 degrees from one another so as to be linearly aligned along lengths thereof. 
     The main cover  920  includes an outer flange  970  that defines the outer perimeter of the main cover  920  and a bottom surface  972 . The opening  925  passes through the bottom surface  972 . Along the bottom surface  972 , the main cover  920  includes a number of movable locking arms  975 . For example, each locking arm  975  is in the form of an elongated arm that includes a first end  977  and a second end  979  that includes a through hole formed therein. The second ends  979  are positioned within the opening  925 . Accordingly, there are four ends  979  that are located in the opening  925 . The first end  977  can be contoured, such as having an arcuate shape (e.g., concave). The second seal  947  is in the form of an under lid seal top cover that is disposed in an annular shaped groove  941  that is formed in the underside of the flange  970 . 
     The back plate  950  is a disk shaped member that includes a first surface (top surface)  952  and a second surface (rear surface)  954 . Each of the first and second surfaces  952 ,  954  has a number of surface features to permit coupling between the components of the docking ring cover  900 . For example, the first surface  952  has a number of recessed channels formed therein and in particular, the first surface  952  can have a central recessed section  953  and there are a plurality of channels  954  that are open at one end to the recessed section  953  and extend outwardly therefrom. The channels  954  can be linear in nature. The back plate  950  also includes a number of through openings (e.g. oval shaped apertures)  990  that are formed therein. At an opposite end, the channel  954  is in communication with the opening  990 . In other words, one end of the channel  954  is in communication with the recessed section  953 , while the opposite end is in communication with the opening  990 . A protrusion or nub  951  is formed within the recessed section  953 . The second surface  954  includes a number of recessed portions. For example, the second surface  954  can include a plurality of circular shaped recesses  955 . The third ring  949  is received within an annular groove that is formed around the periphery of the back plate  950 . 
     The main cover  920  and the back plate  950  are constructed to mate with each other. The first surface  952  faces and engages the bottom surface  972 . The locking arms  975  are received within the channels  954 . Additional details of this coupling are discussed below. 
     The inner knob member  910  has a central upright bridge portion  912  that extends across a width of the knob member  910  and extends upwardly from a floor or base  915  of the knob member  910 . Within the bridge portion  912 , a longitudinal bore is formed that receives an inner locking knob pin  901  and a biasing element  903 , such as a spring. The bridge portion  912  also includes a button (slide pin)  917 , which as described hereinafter, is used to disengage the cover  730  from the body sleeve  710 . The button  917  is in the form of a slide pin that is received in a bore formed in the bridge portion  912  at a right angle to the longitudinal bore. When the slide pin  917  engages the pin  901  (e.g., a distal end of the pin  917  being received into an opening formed along the pin  901 . A release pin  919  is received within an opening formed in the top surface of the bridge portion  912 . The release pin  919  is in communication with the locking pin  901 /biasing element  903  assembly and is designed so that once the pin  919  is removed, the locking mechanism can be operated. 
     An underside of the inner knob member  910  includes a shaped boss or protrusion  990  that has a circular side wall that is shaped and sized to be received within the opening  925 . The protrusion  990  also includes a plurality of fingers or spokes  992 . Each finger  992  has curved side walls and in particular and as shown in  FIG. 14 , adjacent fingers  992  define a sloped surface (cam surface) and between adjacent fingers  992 , a pin or post is shown  994 . In addition, the protrusion includes a center pin  971  that extends outwardly therefrom. When the cover  900  is mated with the top cover  730 , the pin  994  engages the cam pin  742  to cause activation of the locking mechanism of the cover  730 . The pin  995  is received within the opening formed in the second end  979  of the arm  975  which results in the arm  975  being coupled to the protrusion  990 . When the inner knob member  910  is rotated, the rotation of the protrusion  990  causes movement of the arms  975  within the channels  954 . 
       FIG. 14  shows the interlocking arms  975  in retracted positions which corresponds to the unlocked position of the inner knob member  910 . When the inner knob  910  is rotated as described below, the arms  975  are moved longitudinally within the channels  954  so that the first end  977  is moved into the opening  990 . In  FIG. 14 , the rear backing plate  950  is transparent in order to permit viewing of the locking arms  975  in the locked positions. 
       FIG. 2  shows the bag or packaging sleeve  750  installed onto the sleeve assembly (locking member  800 ). Once the bag  750  is installed onto the sleeve assembly, then the docking ring cover  900  can be removed for access to the interior of the packaging sleeve  750  (bag). 
     Once the packaging sleeve body  710  is installed onto the locking member  800 , the locking tabs  720  are received into the cutouts that are formed in the track formed on the underside of the locking member  800 . Some of the locking tabs  720  engage the first locking mechanisms  860  and in particular, the loading of the sleeve body  710  applies a force to the first locking mechanism  860  resulting in the locks on the top cover  730  being released. It will also be appreciated that there are two locking assemblies for both interlocking systems. Once the packaging sleeve  710  is inserted, the interlocks are released for the top cover  730  but the packaging sleeve  710  must then be rotated into the correct docking position for the top cover  730  to engage the interlocks (locking assemblies) for the packaging sleeve. If this is not done, the top cover  730  will not come off and the packaging sleeve will dock. Once the packaging sleeve  710  has been rotated to the docking position, the interlocking mechanism of the docking ring cover  900  can be engaged to the top cover  730  by actuation of their respecting locking mechanisms. In particular, the inner knob  910  is rotated from the unlocked position where it does not align with the protrusions to a locked position, where the inner locking knob  910  axially aligned with the protrusions of the main cover  920 , resulting in the locking arms being moved to their extended positions and into contact with the top cover  730 . 
     Once all inner cover (cover  730 ) to docking ring cover  900  is complete, the user can now rotate the docking ring cover  900  to intimately contact the interlocks for the packaging sleeve  710  and thereby permit removal of the two covers  730 ,  900  together. It will be appreciated that when the covers  730 ,  900  are locked together, the bottom seal of the cover  900  engages (seals) with the top seal of the packaging sleeve cover  730 . 
     Thus, in one embodiment, to open the docking ring cover  900  and remove the cover  730  the following steps are undertaken. The release pin that is part of the inner knob member  910  is pressed. Next, the inner knob member  910  is rotated until it stops. The slide pin is slid to a locked position whereby the inner knob member  910  is securely coupled to the cover  730  and therefore, the cover  730  is lockingly coupled to the ring cover  900 . In the locked position, the inner knob member  910  is not linearly aligned with the protrusions  921  but rather is offset therefrom. The rotation of the inner knob member  910  causes rotation of the cover  730  and in particular, causes the pins  737  of the cover  730  to disengage from the locked position and move to a position where the pins  737  can be disengaged from the corresponding locking channels  739 . The docking ring cover  900  is further rotated and this allows the cover  730  to be removed from the sleeve body  710  by lifting of the attached docking ring cover  900  and the cover  730 . 
     Once the covers  730 ,  900  are locked together and removed from the docking ring assembly, the disposable sleeve (bag)  750  is now locked to the docking ring assembly and will not be able to be removed from the docking ring assembly. In other words, the sleeve body  710  is in a locked position relative to the sleeve locking member  800  and therefore, the sleeve body  710  cannot be pulled from or otherwise easily removed from the sleeve locking member  800 . More particularly, the locking tabs  720  remain in a locked position with respect to the sleeve locking member  800 , thereby preventing separation of the sleeve body  710  from the sleeve locking member  800 . 
     Referring to FIGS.  2  and  6 - 9 , as previously mentioned, the automated bag sealing mechanism  600  is at least partially automated and is configured to receive and seal an item within the material of the bag (protective sleeve)  750 . The mechanism  600  includes a support post (e.g., vertical or inclined)  1000  that includes a guide track  1010  formed along a length thereof. The post  1000  can also include at least one stop  1012  that is designed to limit the travel of an object within the guide track  1010  along the length of the post  1000 . 
     A robotic arm  1100  is coupled to and driven along the guide track  1010  and is configured to perform certain bag handling and processing operations. For example, the robotic arm  1100  can include a horizontal support member  1102  that extends radially outwardly from post  1000  and is preferably coupled to the guide track  1010  at a right angle. A free distal end of the member  1102  includes a pair of controlled grippers (gripping elements)  1110  that can be controlled and moved between an open position in which an item, such as the bag  750 , can be placed between the grippers  1110  and a closed position in which the grippers  1110  are closed and the item between the grippers  1110  is securely grasped and held therebetween. In the illustrated embodiment, each gripper  1110  is an elongated bar like member that has an inner surface that faces the other gripper  1110 . The inner surface is a contact or grip surface that engages the bag  750 . The inner surface can be modified (i.e., roughened) to enhance the gripping characteristics. For example, the inner surface can be a rubber pad or the like. The grippers  1110  can pivot or move linearly between the open and closed positions. 
     Any number of different means can be used to drive the robotic arm  1100  in a controlled manner where the location of the robotic arm  1100  can be precisely monitored and regulated. For example, a stepper motor can be used to drive the robotic arm  1100  vertically along a length of the guide track  1010 . Since the motor&#39;s position can be precisely controlled, a correlation can be made between the number of steps undertaken by the motor and the distance the robotic arm  1100  has been driven. This permits precise control over the location of the robotic arm  1100  along the guide track  1010 . 
     As explained below, the grippers  1110  are intended to grasp the sealed end of the bag (protective sleeve) and linear movement of the robotic arm  1100  is translated into an unfurling action whereby the bag  750  is slowly released from the sleeve body  710 . The tensioning elements (arms)  764  cause a controlled unfurling of the bag  750  from the sleeve body  710  as discussed above. Accordingly, a length of bag material that is unfurled can be easily calculated since the position (a first position or upper position) of where the grippers  1110  grasp the bag  750  is known and the end position of the grippers  1110  after the robotic arm  1100  has been driven to a second position. 
     The sealing mechanism  600  also includes a number of components that seal the bag  750  at select locations and also cut the bag  750  at a select location. More specifically, a heat sealer  1200  is provided for sealing the bag  750  at a specific location. In the illustrated embodiment, the heat sealer  1200  has a first part  1210  and a second part  1220 , each of which is placed into contact with the bag  750  for heat sealing thereof. At least one of the first and second parts  1210 ,  1220  is heated to allow for the local sealing of the bag  750 . In one embodiment, the first part  1210  is a support member that is not heated and the second part  1220  is heated. The first part  1210  is placed against and across one face of the bag  750  and the second part  1220  is placed against and across the opposite face of the bag  750 . 
     The first and second parts  1210 ,  1220  are movable between an engaged position where the respective parts  1210 ,  1220  are placed in contact with the opposite faces of the bag  750  and an open position where the parts  1210 ,  1220  are spaced from and not in contact with the bag  750 . In the illustrated embodiment, each of the first parts  1210 ,  1220  is operatively connected to a shaft that is driven (e.g., rotated) by a motor. When actuated, the motors cause the shaft to rotate and depending upon the direction of rotation, the parts  1210 ,  1220  are either driven toward one another into contact with the opposite faces of the bag  750  or they are driven away from one another, thereby being removed from contact with the bag  750 . The parts  1210 ,  1220  can be driven independent from one another or they can be driven at the same time. The motion of the parts  1210 ,  1220  is similar to a wiping action. 
     In one exemplary heat sealing operation, the second part  1220 , which is not heated, is first driven to its engaged position. This driving action results in the second part  1220  being placed into contact with the bag  750  (see  FIG. 7 ). The second part  1220  is maintained in this engaged position, thereby applying an inward force to the bag  750 . Next, the second part  1220  is then manipulated (driven) to its engaged position and as it is driven into engagement with the opposite face of the bag  750 , the heat element of the second part  1220  engages the bag  750 . This results in the bag  750  being captured and compressed (pinched) between the two parts  1210 ,  1220  and a heat seal is formed in the bag  750 . Since the first and second parts  1210 ,  1220  are elongated horizontal structures, the heat seal is a linear seal that extends horizontally across the bag  750 . In one embodiment, the heat seal actually consists of two distinct heat seals that are spaced from one another with an unsealed area therebetween. 
     The scaling mechanism  600  also includes a cutting element (cutter)  1300  that has a blade or the like for cutting the bag  750  at a specific location. The cutting element  1300  can be a linear blade  1302  that is horizontally oriented so that the bag  750  is cut horizontally across its width. Similar to the first and second parts  1210 ,  1220 , the cutting element  1300  can be moved between different positions. More specifically, the cutting element  1300  can be moved between an engaged position where the cutting element  1300  is placed in contact with one face of the bag  750  (e.g., the face that the second part  1220  has contacted) and an open position where the cutting element  1300  is spaced from and not in contact with the bag  750 . In the illustrated embodiment, the cutting element  1300  is operatively connected to a shaft that is driven (e.g., rotated) by a motor. When actuated, the motor causes the shaft  1310  to rotate and depending upon the direction of rotation, the cutting element  1300  is either driven toward the bag  750  or is driven away from the bag  750 , thereby being removed from contact with the bag  750  (see  FIG. 8 ). As with the motion of the parts  1210 ,  1220 , the action of the cutting element  1300  follows a wiping action. 
     As shown, the cutting element  1300  and second part  1220  can be disposed on the same side of the bag  750 , while the first part  1210  is located on the other side of the bag  750 . The paths of the cutting element  1300  and the second part  1220  at least partially overlap and therefore, both components can not engage the bag  750  at the same time. 
     The location of the cutting element  1300  and in particular, the blade  1302  relative to the heat element of the second part  1220  is selected so that bag  750  is cut within the unsealed space that is formed between the two heat sealed region. In other words, the bag  750  is cut at a location that results in the bag material being sealed above the cut line and sealed below the cut line. 
     The normal operating procedure is that after the second part  1220  has engaged and heat sealed the bag  750  and is then moved to its open position, the cutting element  1300  is then moved into its engaged position. This action results in the sharp blade  1302  being driven into contact with the bag  750  resulting in the bag  750  being cut. Since the first part  1210  remains in the engaged position, the first part  1210  provides a solid substrate against which the bag  750  and the cutting element  1300  can be driven with force against the bag  750  to cause a shearing of the bag  750 . The cutting element  1300  is then moved back to the open position and the second part  1220  is driven to its open position by driving the shaft in an opposite direction causing disengagement of the second part  1220  from the bag  750 . At this point, the bottom sealed end of the bag  750  remains held between the grippers at one thereof and the top sealed end is free and folds over and is directed towards a collection or storage bin  1400 . The grippers  1110  are then opened (e.g., pivoted open) and the bag  750  falls into the storage bin  1400  where it is collected (see  FIG. 9 ). 
     Once the sealed bag  750  which contains an item, such as a drug filled syringe, a container, waste (such as contaminated wires, etc.) or replaced/serviced parts, etc., is disposed within the storage bin  1400 , the steps of the bag sealing action are repeated. In particular, the loose sealed end of the bag  750  (defined by the section of the heat seal that was located above the cut line) is captured by the grippers  1110  when they are driven to their up position. The grippers  1110  are then closed to capture the sealed bottom end of the bag  750  and then the robotic arm  1100  is driven downward to a bottom position (the precise location can depend on the size of the item) that is to be inserted into the bag  750 . For example, if a larger item is to be inserted into the bag  750 , a greater length of bag material needs to be unfurled from the sleeve body  710 . 
     The item is only inserted when the sealed end of the bag  750  is captured between the grippers  1110  and the robotic arm and grippers  1110  are in the bottom extended position (i.e., a length of bag material has been unfurled). After insertion of the item, the heat sealing and cutting processes proceed as described above. 
     It will also be appreciated that the bag  750  can be designed so that it provides ability to hang a dose without removing the over wrap completely. For example, the bag  750  can have a sealed opening that allows the bag  750  to be hung. In addition, the bag material is non-permeable to the drug or other hazardous contents located therein. 
     The robotic arm  1100  and other operative parts of the automated system are in communication with a controller processor) that is part of a computer system that includes software that has executable code that controls the actions of the robotic arm  1100 , the grippers  1110 , etc. For example, an operator input can be provided for entering information such as the type and/or size of the item that is being inserted into the open end of the packaging sleeve for sealed enclosure therein. Based on this information, the controller can determine the distance that the robotic arm  1100  needs to travel along the guide track  1010  in order to unfurl the proper length of bag material and thereby provide an adequate interior space in the bag  750  for containing the item and allowing the heat seal and cut line to be formed above the item. For example, the operator can input that the item being inserted is an IV bag and can even input a size of the IV bag or that it is a particular type of syringe; drug vial; etc. 
     In addition, once the sealing mechanism  600  has determined that the packaging sleeve body  710  contains the last bag protective sleeve)  750 , the operator is signaled (alerted) or otherwise warned that the disposable sleeve  700  needs to be replaced. The signal can be in the form of an audible or visual alarm or indicator, or a combination thereof. In other words, the sealed second end of the bag  750  that is captured by the grippers  1110  should not be pulled (unfurled) in a direction away from the first end  712  of the sleeve body  710  since no additional length of bag material is left to be unfurled and this could result in the sealed, attached first end of the bag  750  being detached from the first end of the sleeve body  710 . This would result in a potentially hazardous situation since the sealed environment of the sleeve body  710  and the third section  400  of the system is destroyed. The operator is thus exposed to contaminants, such as cytotoxin drug particles, that may be present along the inner surface of the sleeve body  710 . 
     When the sleeve  700  needs to be replaced, the covers  900 ,  730  need to be reinstalled so that the finished packaging sleeve  700  can be removed and disposed of. First, the button  917  on the side of the docking ring cover  900  is pressed. This resets the lock for the disposable sleeve top cover  730 . Second, the combined docking ring cover  900  and the disposable top cover  730  are re-installed by placing the combined cover  900  and top cover  730  back onto the sleeve locking member  800  and then rotating the docking ring cover  900  to re-install both covers  900 ,  730  onto the sleeve locking member  800  and the sleeve body  710 . The button  917  is then slid to the unlock position on the inner knob  910 . This will unlock the inner knob  910  of the docking ring cover  900 . Next, the inner knob  910  of the docking ring cover  900  is rotated to the un-lock position. Once these covers  900 ,  730  are unlocked, the disposable packaging sleeve  710  is unlocked and can be removed from the docking ring assembly. After removal of the sleeve body  710 , a new sleeve body  710  can be inserted and locked in place using the procedure previously discussed herein. 
     While the invention has been described in connection with certain embodiments thereof, the invention is capable of being practiced in other forms and using other materials and structures. Accordingly, the invention is defined by the recitations in the claims appended hereto and equivalents thereof.