A PACKAGING AND COMPONENT DELIVERY SYSTEM FOR USE IN STERILE MEDICAL OR DENTAL PROCEDURES

Abstract: The present invention relates to a packaging and component delivery system for use in sterile medical or dental procedures which enables an operator to carry out surgical procedures using a conventional aseptic surgical technique, to pick up and manipulate the package and deliver the sterile contents for use during the procedure. The packaging intended to contain sterile items is provided with openings, attachments or other features or accoutrements that facilitate and enable manipulation and opening of said packaging by means of dedicated instrumentation. The materials that form the packaging are folded back upon themselves to create said openings.

Description: A packaging and component delivery system for use in sterile medical or dental procedures. For many surgical procedures conducted under conventional high standards of cleanliness and sterility (i.e. good aseptic technique) , components or materials such as bone screws, implants, dental implants and components, suture materials and wound dressings, must be selected during the course of the procedure. The surgeon may wear sterile gloves and sterile gown, and it would not be appropriate to handle the non-sterile exterior of a package. In current practice, this problem is usually overcome by asking an assistant who is not otherwise involved in the actual procedure to open the package and tip out the sterile contents within onto a sterile surface, or otherwise permit the sterile item to be withdrawn from the packaging. The present invention relates to an adaptation of existing packaging systems which will permit a non- sterile package to be selected and opened, and the sterile contents removed and delivered onto a sterile surface. This process may be carried out by the operator working under sterile operating condi- tions, without compromising the cleanliness or sterility of the procedure. This eliminates the need for an assistant, and facilitates the selection of exactly the items that the operator requires, with minimal interruption of the proceedings. A specific embodiment of the invention will now be described with reference to figures 1, 2 and 3. SUBSTITUTE SHEET{HOLE 26) Figure 1 illustrates a rectangular package which comprises a backing 1 consisting of a paper label laminated with a polymeric film. The front part of the package consists of a vacuum formed polymeric film 2. These parts are bonded together to create a pocket 3 containing an item or items 4 that must be delivered sterile at operation. At one end of the package, the backing 1 is folded onto itself to create a tubular opening 5 which runs along the length of the short side of the package. The front part of the package 2 is also folded onto itself to create a similar tubular opening 6. Figure 2 illustrates a dedicated instrument for manipulation and opening of the packet. The relatively heavy handle of the instrument 8 is provided with apertures for finger and thumb, resembling in this respect the handles of a pair of scissors . The arms of the instrument are hinged at a fulcrum point about one third of the way along the instrument by means of a rivet 9. A spring 10 holds the handles apart unless they are actually squeezed toget- her. At the functional end of the instrument the last section bends to form two extensions 12, running parallel to each other, and approximately perpendi- cular to the length of the instrument. Each extension is shaped in cross section to fit into the openings of the "tubes" 5,6 formed in the packaging material. The extensions are slightly longer than the tubes to permit the instrument to be fully inserted into the tubes. At the tip of each extension a small ledge 13 is created. Approximately two thirds of the way along the instrument, and facing in the opposite directions to the extensions, there is positioned a protruding rest 14. When not in use the instrument balances upon this rest, and the relatively heavy handles 8. Figure 3 illustrates (plan view) a storage tray or organiser tray for packages of the type described in figure 1. The tray comprises a shallow cardboard box 15, having dimensions which will comfortably accommodate a row of several of the packages, which are stored and transported in a low profile, well protected position 16 in which the vacuum molded part of the package protrudes into the shallow box through a cut-out portion 17 of a cardboard support 18, which is recessed into the box. The cut-out portion 17 in the cardboard support is also shaped to accommodate the package in an alter- native orientation 19, in which the openings of the "tubes" 5,6 formed in the parts of the packages may be easily accessed by the extensions of the instrument during a surgical procedure, thus effectively converting the storage tray into an organiser or rack. The packages are raised off the base of the box by a small amount, and maintained in position by means of two slotted corrugated cardboard strips (not shown) , which run between the cardboard support and the base of the box so that the ledges 13 at the tips of the instrument extensions 12 are able to pass beyond, and engage the packaging. There is also provided a lid (not shown) that sits over the box and contents when the packages are in the "storage" position 16, so as to provide protection during transportation and storage. In use, the surgeon carrying out the sterile procedure picks up the sterilised instrument in a gloved hand. Various packages containing a range of different items are preposi tioned close by, or arranged in the appropriate storage rack, so that the openings of the tubes formed in the parts of the package may be easily accessed by the extension of the instrument. The extensions of the instrument are inserted into the tubes formed in the parts of the package selected by the surgeon, so that the tips of the extensions protrude past the ends of the tubes. Gently squeezing the handles separates the extensions. The notched tips of the extensions then retain the package in place on the instrument. The instrument is then held over a sterile surface; further pressure on the handles separates the front and back of the package along the relatively weakly bonded interface, and the contents of the package may then be emptied out. After initial use the opened packaging is allowed to fall away from the instrument. The instrument is then replaced on the sterile surface, making sure that the extensions, which have now been in contact with the non-sterile exterior of the package do not contact other sterile items.

Claims: C LAIMS 1. A packaging system comprising instrumentation, sterilisable packaging, and storage trays or organiser racks for sterile products, which enables an operator carrying out surgical procedures using a conventional aseptic surgical technique, to pick up and manipulate the package, and deliver the sterile contents for use during the procedure. 2. Packaging intended to contain sterile items within, which is provided with openings, attachments, or other features or accoutrements that facilitate and enable manipulation, and opening, of said packaging by means of dedicated instrumentation, intended for use by an operator who is carrying out sterile surgical procedures, and who must not comp- romise the aseptic surgical technique, or the sterility of the items contained within the package. 3. A package as described in claim 2, in which the materials that form the packaging are folded back upon themselves to create openings which may be engaged by appropriate instrumentation used to manipulate and open the packaging. 4. A package as described in claim 2, in which the materials that form the packaging are perforated to create openings which may be engaged by appropriate instrumentation used to manipulate and open the packaging . 5. A package as described in claim 2 , in which tubular sections of paper, cardboard, metal, or polymeric material are fixed to the packaging so as to create openings which may be engaged by appro- priate instrumentation used to manipulate and open the packaging. 6. A package as described in claim 2, in which sec- tions of a paper, cardboard, metal, or polymeric material are fixed to, or protrude from, the packaging so as to create tags which may be engaged by specially designed or adapted instrumentation used to manipulate and open the packaging. 7. A dedicated instrument, which is an element of the packaging system outlined in the preceding claims, with functional extensions designed to engage, grasp or mate with a package containing a sterile item, which is provided with features which accommodate the functional end of the instrument. 8. An instrument as described in claim 7, which when placed on a flat surface is balanced so as to always balance upon a sterile handle and rest, so that it may be placed upon a sterile surface, without contamination of that surface by the functional end of the instrument which will come into contact with the non-sterile exterior of the matched packaging . 9. Storage or organiser trays or racks for the packages described in preceding claims, in which the packages are ideally positioned to allow retrieval by the instruments described in the preceding claims, with minimal risk of the non-sterile exterior of the stored packages contacting the surgeon's gloved hand, or that part of the instrument which is grasped by the surgeon's gloved hand. 10. Storage or organiser trays or racks for the packages described in preceding claims, in which the packages may be positioned in a well protected enclosure within the tray for the purposes of sto- rage or transportation, but may be reoriented so as to be ideally positioned to allow retrieval by the instruments described in the preceding claims, with minimal risk of the non-sterile exterior of the stored packages contacting the surgeon's gloved hand, or that part of the instrument which is grasped by the surgeon's gloved hand. 11. A packaging system substantially as herein described and illustrated in the accompanying drawings .

Inventors: DAWOOD J S ANDREW, DAWOOD, J., S., ANDREW
Applicants: DAWOOD J S ANDREW, NOBEL BIOCARE AB, DAWOOD, J., S., ANDREW, NOBEL BIOCARE AB (PUBL)
Application year: 1998
Main classification: B65D83
IPC codes: A61B19, B65D75