Abstract:
An information holder for holding informational documents used to track and identify medical instruments can be releasably attached to a sterilization container or tray. The information holder includes an autoclavable material pouch and a releasable attachment structure coupled to the pouch for securing the information holder to sterilization container or tray. The attachment structure can include adhesive or a handle-engaging member. The information holder can be removed from the container or tray after sterilization without breaching the sterilization of the contents contained within sterilization container or tray. The information holder can be re-attached to the same or a different container.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit under 35 U.S.C. 119 of Provisional Application No. 61/310,034, filed Mar. 3, 2010, which is incorporated herein by reference in its entirety for all purposes. 
    
    
     TECHNICAL FIELD 
     The present invention relates to an information holder for medical instruments and/or medical instrument trays for tracking and identification purposes before and after sterilization. 
     BACKGROUND OF THE INVENTION 
     The tracking and identification of surgical instruments and/or surgical devices after they have been cleaned and sterilized for use in the operating environment is difficult. After devices have been cleaned they are placed into rigid sterilization containers or are placed in sterilization baskets/trays and are then wrapped with sterilization paper. The rigid containers cannot be opened and the sterilization paper cannot be removed as sterility will be compromised. Thus, identification of these devices in the rigid containers or sterilization trays cannot be done by visually inspecting them. The number and identification of these devices is generally accomplished through manual record keeping. Hospital staff will record the contents of the sterilization tray on an informational document, some of which are commonly referred to as a “Count Sheet”, and will place this informational document or multiple informational documents into the rigid sterilization container or in a sterilization tray/basket, which is then wrapped with sterilization paper. The difficulty with this methodology is that the informational document(s) placed into the sterilization tray may compromise or otherwise create an issue with the sterilization of the devices inside the sterilization tray. 
     SUMMARY OF THE INVENTION 
     One embodiment of the invention is a holder or container for surgical instrument informational documents that can be releasably attached to a sterilization tray or container. One embodiment of the holder includes a polymer pouch. In another embodiment of the invention, the pouch substantially encloses the informational documents. Other embodiments of the invention have adhesive with a release liner or another attachment structure on the holder for attaching the holder to the tray. In another embodiment, the releasable attachment structure includes a handle-engaging member such as a looped member, a strap, or a releasable cable tie. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A and 1B  are front and back schematic views of an information holder in accordance with an embodiment of the present invention. 
         FIG. 1C  is a schematic view showing the information holder of  FIGS. 1A and 1B  in use. 
         FIGS. 2A and 2B  are front and back schematic views of an information holder in accordance with another embodiment of the present invention. 
         FIG. 2C  is a schematic view showing the information holder of  FIGS. 2A and 2B  in use. 
     
    
    
     While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. 
     DETAILED DESCRIPTION 
     The invention is an information holder that has a number of important features. The information holder can hold the informational document(s) in a manner that will not impede sterilization of the surgical instrument/surgical devices within the sterilization container or tray. The holder facilitates easy removal and review of the informational document(s) without compromising the sterility of the surgical instrument/surgical devices within the sterilization container or tray. The holder also can be quickly and easily attached and removed if needed from the outside of the sterilization container or tray. Additionally, the information holder, according to the various embodiments as described herein, provides a rapid method for the hospital staff to hold and attach the informational document(s) without the worry of impeding sterilization, and that facilitates a quick review of the informational document(s) without needing to open the tray, which may possibly breach sterilization. 
       FIGS. 1A and 1B  are front and back views of an information holder  10  according to one embodiment of the invention. As shown in  FIGS. 1A and 1B , one embodiment of the information holder  10  includes transparent, autoclavable polymer material  14 , which can, but need not be, biodegradable, and that is manufactured into the shape of a pouch  30 , sealed at the bottom  18  and both sides  22   a ,  22   b , and open at the top  26 , thus forming a bag or pouch or other container to hold and preferably substantially enclose the informational document(s)  34 . One example of an informational document that can be enclosed in the pouch  30  is a count sheet for recording the contents of a sterilization container or tray. 
     Double sided tape  38 , made of a polymer carrier, a polymer release liner, and adhesive on both sides, can be adhered to the back side  42  of the pouch  30 . A release liner  46  remains on the adhesive  50  on the side of the double sided tape  38  that is not adhered to the pouch  30 . The pouch  30  is preferably large enough to hold multiple informational documents  34  securely. In other embodiments, other releasable structures, such as clips attached to the pouch, can be used to releasably attach the pouch to the instrument tray. 
       FIG. 1C  shows the information holder  10  in use with a sterilization tray  54  including an optional lid  56 . In use, according to one embodiment, the user can fold the informational document(s)  34  and place them into the information holder  10 . The user removes the release liner (not shown) and attaches the information holder  10  to the sterilization tray  54  via the adhesive strip on the backside of the information holder  10  (or otherwise attaches the holder  10  to the tray  54 ). The sterilization tray  54  with the information holder  10  is then placed into the sterilizer. When removed from the sterilizer, the user may remove and view the informational document(s)  34  without fear of breaching sterilization and can place the informational document(s) back into the information holder  10  to maintain identification of the items in the sterilization tray  54 . 
     The information holder  10  can be removed and reused. The information holder  10  can remain on the sterilization tray for additional use or may be removed by simply grabbing onto the information holder  10  and pulling it off of the sterilization tray  54 . For example, as described above according to one embodiment, the adhesive holding the information holder  10  to the sterilization tray  54  will release when the information holder  10  is pulled away from the tray  54 . The information holder  10  can then be placed onto another sterilization tray. 
       FIGS. 2A and 2B  are front and back views of an information holder  100  according to another embodiment of the present invention. Like the information holder  10 , described above with reference to  FIGS. 1A-1C , the information holder  100  is configured for releasable attachment to a sterilization tray ( FIG. 2C ). The information holder  100  includes transparent, autoclavable polymer material  104 , which can, but need not be, biodegradable, and that is manufactured into the shape of a pouch, sealed at the bottom  108  and both sides  112   a ,  112   b , open at the top  116 , thus forming a bag or pouch  120  or other container to hold and preferably substantially enclose the informational document(s)  124 . According to various embodiments, the pouch  120  is large enough to hold multiple informational documents  124  securely. One example of an informational document  124  that can be enclosed in the pouch  120  is a count sheet. 
     Additionally, as shown in  FIGS. 2A and 2B , the information holder  100  includes at least one aperture  128  formed in both the front  132  and back  134  of the pouch  120 . In one embodiment, the aperture  128  formed in the front  132  of the pouch  120  is superimposed over the aperture  128  formed in the back  134  of the pouch  120 . According to some embodiments, the apertures  128  can be die cut holes or slits formed in the front  132  and/or back  134  of the pouch. 
     As shown in  FIG. 2C , the information holder  100  also includes a handle-engaging member  140 , such as, for example, a cable tie, strap, looped member or other similar attachment means for attaching the information holder to the sterilization tray  150 . The handle-engaging member  140  is looped through the apertures  128  provided in the front  132  and back  134  of the pouch  120  and around a handle  144  of the sterilization tray  150  to attach the information holder  100  to the sterilization tray  150 . In preferred embodiments of the invention the member  140  is configured as a releasable member (e.g., it can have a buckle or can be broken by physical force). In other embodiments of the invention the handle-engaging member  140  is attached to pouch  120  by other approaches (e.g., is adhesively attached to the pouch). 
     Referring to  FIG. 2C , which shows the information holder  100  in use, the user can fold the informational document(s) and place them into the information holder  100 . The user inserts the handle-engaging member  140  through the apertures  128  provided in the front  132  and back  134  of the pouch  120  and loops the handle-engaging member  140  around the handle  144  of the sterilization tray  150 , securing the handle-engaging member  140  to the sterilization tray  150 . The sterilization tray  150  with the information holder  100  including the information document(s) enclosed therein is then placed into the sterilizer. When removed from the sterilizer, the user may remove and view the informational document(s) without fear of breaching sterilization and can place the informational document(s) back into the information holder  100  to maintain identification of the items contained in the sterilization tray  124 . The information holder  100  can remain on the sterilization tray  150  for additional use or the information holder  100  can be removed and reused by attaching the information holder  100  to another sterilization tray. 
     In other embodiments, the information holder, as described herein, is opaque. In still other embodiments, the information holder can be manufactured with various clear or colored polymers for immediate visual identification. Different colors may be used to identify different types of surgical procedures, surgeon owned instruments, configurations, locations, etc. Clear information holders allow for inspection of the informational documents within. Materials other than polymers can also be used for the pouch. 
     The sterilization environment for surgical instrument/surgical devices is severe involving heat, moisture, chemicals and gases or any combination thereof. The information holders&#39; polymers or other components and adhesives are stable in this environment. 
     As an example, one embodiment of the invention includes a pouch formed from high density polypropylene (HDPE). A carrier formed from material such as polyethylene terephthalate (PTE) is attached to the pouch by a permanent acrylic adhesive. A removable acrylic adhesive that is used to releasably secure the pouch (and carrier) to the sterilization tray is applied to the side of the carrier opposite the permanent adhesive. A liner of material such as low density polyethylene (LDPE) can be applied over the removable adhesive to protect the carrier and adhesives prior to use of the information carrier. When the liner is removed the information carrier can be attached to the sterilization container. 
     Although the invention is described and shown in connection with the embodiments described herein, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the invention.