Patent Publication Number: US-2023149584-A1

Title: Medical instrument sterilization backer card

Description:
RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Application No. 63/304,901filed on Jan. 31, 2022. This application is also a continuation-in-part of U.S. application Ser. No. 17/160,816, filed on Jan. 28, 2021. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to the sterilization of used medical instruments. More particularly, the present invention relates to a medical instrument sterilization backer card that immobilizes the medical instrument during and after the sterilization process. 
     BACKGROUND OF THE INVENTION 
     As is well known in the medical profession, the sterilization of precision medical instruments must be accomplished with certain purposes in mind. Basically, for both economic and efficiency reasons, such sterilization needs to be done in a manner which will ensure the most effective exposure of the instrument to the sterilizing medium while minimizing the possibility of contaminating the instrument prior to its use. Obviously, a major concern in this process is the actual handling of the instrument. In order to meet the need for effective handling of a medical instrument during sterilization, various packaging techniques have been proposed. The prior art devices, however, do not incorporate into one package all of the features which are deemed desirable for the most effective handling of a medical instrument during sterilization and between the time it is sterilized and its subsequent use. 
     One desirable feature of an instrument protector is that it immobilize the instrument. Such immobilization, particularly for medical instruments which are pointed or which have cutting or sharp edges, reduces the possibility of dulling or blunting their surfaces by contact with or rubbing against other surfaces. Yet another desirable feature for an instrument protector is the added protection it can give against an inadvertent puncturing of the outer sterilizable envelope by the instrument&#39;s sharp or pointed surfaces. 
     Sometimes, tip protectors are placed over the cutting ends or edges of the medical instrument. However, the tip protector&#39;s tight fit onto the instrument creates doubt as to whether the instrument gets sterilized completely. It is recommended not to use clear or colorless tip protectors in order to protect against the chance of retained surgical items in the wound by inadvertently leaving the tip protector on the medical instrument. The tip protectors are typically comprised of a plastic material, and the tip protectors and the labor required to attach and detach them may make them less convenient and more expensive than sterilization cards. 
     Another desirable feature is that the instrument protector present the instrument for sterilization in a configuration which will allow the greatest exposure of the instrument to the sterilizing medium. Oftentimes, the protector devices to which the medical instrument is attached prevents the sterilizing medium from freely flowing over all parts of the medical instrument to fully sterilize it. 
     Additionally, it is desirable if some provision is made for easy identification of the instrument. Preferably, such identification can be done visually and thus obviate the use of external labels which may cause confusion if the protector is used with a different instrument. This last consideration is particularly important when it is envisioned that any particular embodiment of a sterilizable instrument protector can be used with a plurality of different instruments. 
     Use of the instrument protector must be effective regardless of the particular sterilization process utilized. Two common sterilization processes include the use of steam, and in other cases ethylene oxide (ETO) which may be used when the medical instruments are moisture or heat sensitive or otherwise cannot be sterilized by steam sterilization. 
     Accordingly, there is a continuing need for an instrument protector which immobilizes the instrument both during and after sterilization. There is also a continuing need for an instrument protector which allows the greatest exposure of the instrument to the sterilizing medium without inadvertent puncturing. Such an instrument protector should be usable with a plurality of different instruments and allow for easy identification of the instrument. What is also needed is an instrument protector which is convenient and easy to use and relatively inexpensive. The present invention fulfills these needs and provides other related advantages. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a medical instrument protector, in the form of a medical instrument sterilization backer card, which immobilizes the medical instrument both during and after sterilization. The backer card of the present invention allows for the exposure of the medical instrument to sterilizing medium while protecting and covering points and sharp edges of the medical instrument which could otherwise inadvertently puncture an outer sterilizable envelope. The sterilization backer card of the present invention is convenient and easy to use and relatively inexpensive and allows for easy identification of the medical instrument. 
     The medical instrument sterilization backer card of the present invention comprises a generally planar base. A first flap extends from a first end of the base. The first flap is movable from a non-deployable position extending away from the base to a deployed position folded over the base and forming an open-ended pocket configured to receive an end of a shaft of the medical instrument therein. A second flap extends from a second end of the base. The second flap is movable between a non-deployable position extending away from the base to a deployed position over the base and forming a shell defining a compartment configured to receive a head of the medical instrument therein. 
     The first flap may have tabs which are insertable into tab slots formed in the base to hold the first flap in position relative to the base. The tabs may be partially inserted into the tab slots to maintain the first flap in a spaced relation to the base. 
     A window may be formed in the first flap. The window may facilitate visual identification of the medical instrument and/or facilitate exposure of the instrument to the sterilizing medium. 
     The second flap typically has multiple sections foldable relative to one another to form the shell so as to at least partially surround the head of the medical instrument. A top section of the second flap may have a window formed therein. The window may be used to facilitate exposure of the medical instrument to the sterilizing medium and/or provide easy visual identification of the medical instrument. 
     A locking mechanism retains the second flap into a folded, deployed position over the base. The locking mechanism may comprise a first locking member detachable from the base and a second locking member formed in the second flap that lockingly engages the first locking member. The first locking member may comprise a belt partially detachable from the base, and the second locking member may comprise a slit formed in the second flap. The belt extends over the deployed second flap and into the slit. The first locking member may instead comprise a wall lifted upwardly from the base and having a slot formed therein. A wing formed in the second flap is insertable into the slot wall and forms the second locking member. 
     A sterilization indicator retainer may be formed in the base for holding a sterilization indicator or integrator therein. 
     A fingerhold may extend from the base which has an aperture sized for insertion of a finger therethrough for lifting and moving the sterilization backer card and attached medical instrument. Alternatively, or in addition, a fingerhold aperture may be formed through the base which is sized for insertion of a finger therethrough. 
     An eyelet may be formed in the base intermediate the ends thereof which has an aperture or notch formed therein. The eyelet is pivotable upwardly from the base to receive the shaft of the medical instrument. Alternatively, or additionally, a notch may be formed in the second flap that receives the shaft of the medical instrument therein. 
     Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings illustrate the invention. In such drawings: 
         FIG.  1    is a top view of a medical instrument sterilization backer card in an unfolded state; 
         FIG.  2    is a side perspective view of the backer card of  FIG.  1    in a folded state; 
         FIG.  3    is a top view of the backer card of  FIG.  2    supporting a medical instrument, in accordance with the present invention; 
         FIG.  4    is a partially fragmented and enlarged perspective view of area “ 4 ” of  FIG.  3   , illustrating an end of the folded backer card surrounding a head of the medical instrument, in accordance with the present invention; 
         FIG.  5    is a top view of a medical instrument sterilization backer card embodying the present invention; 
         FIG.  6    is a side perspective view illustrating the backer card of  FIG.  5    in a folded state; 
         FIG.  7    is a top plan view of the backer card of  FIG.  6   , supporting a medical instrument thereon, in accordance with the present invention; and 
         FIG.  8    is an enlarged perspective view of area “ 8 ” of  FIG.  7   , illustrating an end of the backer card surrounding a head of the medical instrument, in accordance with the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     As shown in the accompanying drawings and photographs, for purposes of illustration, the present invention is directed to an instrument protector backer card, generally referred to by the reference number  100 , for holding and protecting a medical instrument. The instrument protector backer card  100  provides a mounting surface configured to hold and maintain and protect a medical instrument, such as for sterilization and the like. 
     The backer card  100  is comprised of a material which can be printed and/or dye cut, subjected to sterilizing steam and/or chemicals, and which can securely and protectively hold a medical instrument  10 , typically a medical or surgical instrument or the like, thereon such as for sterilization processes and the like. The backer card  100  of the present invention is typically comprised of a paper material of a sufficient thickness, such as at least 14 pt. thickness, so as to securely hold the instrument  10  thereon and enable certain aspects of the backer card  100  to be manually bent, folded and the like by the user when attaching the medical instrument  10  thereto. In a particularly preferred embodiment, the backer card  100  is comprised of a solid bleached sulfate (SBS), which is a bleached virgin fiber grade of paper board of high quality. It has been found that using a 14 pt. paper board material enables the user to manually manipulate and articulate portions of the backer card  100  while retaining the medical instrument  10  securely on the backer card. The SBS paper board material is steam sterilization and ethylene oxide friendly. 
     While the medical instrument protector backer card  100  of the present invention could be used with a variety of devices, and is particularly configured for use with medical instruments having a head  12  and shaft  14  portions. In a particularly preferred embodiment, the instrument protector backer card  100  is configured for use with a Davinci instrument having a head portion  12  and a shaft  14  extending therefrom, such as used in Davinci robotic surgical systems. The end of the shaft or jaw  16  of such systems may have attached thereto various accessories, such as hooks, forceps, drivers, etc., needed for surgical purposes. The entire medical instrument  10 , including the head  12 , shaft or jaw  14 , and attached accessory can be supported and protected when partially enveloped and held in place on the folded instrument protector backer card  100  of the present invention. This enables the medical device  10  to be sterilized, stored, transported, etc. when connected to and supported by the instrument protector backer card  100  of the present invention. 
     With reference now to  FIG.  1   , a backer card  100  embodying the present invention is shown in an unfolded state. The backer card  100  has a generally planar base  102  forming an elongated middle portion of the unfolded backer card  100 , as illustrated in  FIG.  1   . The base  102  serves as a support member for the medical device  10 . 
     A first flap  104  extends from a first end  106  of the base  102 . The first flap  104  is movable from a non-deployed position, extending away from the base  102 , as illustrated in  FIG.  1   , to a deployed position folded over the base  102  to form an open-ended pocket which receives an end  16  of the shaft  14  of the medical instrument  10  therein, as illustrated in  FIGS.  2  and  3   . As illustrated in  FIGS.  1 - 3   , the flap  104  is elongated, such as being preferably of a sufficient length so that an end portion  16  of shaft  14  of different lengths or configurations may be inserted therein to accommodate different medical instruments or medical instruments having varying shaft lengths. The flap  104 , as illustrated in  FIGS.  1 - 3   , is of a width less than that of the base  102 , such as being approximately one-half or less the width of the base  102 , although it is not necessarily limited to such. 
     The first flap  104  may include tabs  108  and  110  which may be folded from a generally planar position, as illustrated in  FIG.  1   , to a downward position, as illustrated in  FIGS.  2  and  3   . Score lines  112  and  114  may be used to assist in the folding of the tabs  108  and  110 . The tabs  108  and  110  are insertable into tab slots  116  and  118  formed in the base  102  a distance from end  106  corresponding to the length of the flap  104 . The tabs  108  and  110  may be of a height or dimension so as to extend upwardly from the base  102  after being inserted, or partially inserted, in tab slots  116  and  118  such that the first flap  104  is spaced from the base  102  a desired distance. 
     With reference now to  FIGS.  1  and  2   , the first flap  104  extends from the first end  106  of the base  102  along a score line or fold line  120 . This facilitates the folding of the flap  104  over the base  102  when moved from a non-deployed position to a deployed position, as mentioned above. A second score line or fold line  122  may be formed a distance from the first score line  120  to form a wall  124  comprised of the space between the score lines  120  and  122 . This wall, as illustrated in  FIG.  2   , also raises the flap  104  a distance from the base  102  to provide a compartment of a desired dimension within the pocket cooperatively formed by the deployed flap  104  and base  102 . The space between the flap  104  and the base  102  can be altered by altering the distance between fold or score lines  120  and  122 . Such spacing can also, or alternatively, be altered by increasing or decreasing the size of tabs  108  and  110 . As illustrated, the use of the tabs  108  and  110  and the wall  124  formed by the space between score lines  120  and  122  cooperatively raise the flap  104  a distance from the base  102  to create a compartment within the pocket in which the end  16  of the shaft  14  of the medical instrument  10  can reside. Such a compartment within the pocket may enable the end  16  of the shaft to not come into contact with the base  102 , flap  104 , or other structure of the backer card  100  when the end  16  of the shaft  14  is inserted into the pocket. 
     The pocket formed by the base  102  and flap  104  has an opening  126  for insertion of the shaft  10  therethrough. In a particularly preferred embodiment, as illustrated, the pocket is open-ended, with the opening  126  being defined by substantially the length or width of the end of the flap  104 . In this manner, ends of medical instruments having varying sizes or configurations may be inserted into the pocket  128 . 
     With reference now to  FIGS.  5 - 7   , a cutout  130  may be formed through the flap  104  so as to create a window  130  within the first flap  104 . This window  130  is sized and positioned so as to reside over the end  16  of shaft  14 . The window  130  may have multiple purposes. First, the window  130  enables sterilant fluid, such as steam or ETO, to more freely penetrate and pass through the pocket  128 , and thus expose the end  16  of shaft  14  of the medical instrument  10  to the sterilant. The window  130  may also be used to see and visually identify the end  16  of the medical instrument  10 . This may assist a user in determining the type or characteristic of the medical instrument  10 . 
     With reference now to  FIGS.  1 - 4   , a second flap  132  extends away from a second end  134  of the base  102 . The second flap is movable between a non-deployed position extending away from the base  102 , as illustrated in  FIG.  1   , to a deployed position over the base  102  and forming a shell defining a compartment configured to receive the head  12  of the medical instrument therein, as illustrated in  FIGS.  2 - 4   . Typically, the second flap  132  has multiple sections foldable relative to one another to form the shell that at least partially surrounds the head  12  of the medical instrument  10 . More particularly, the second flap  132  has a first section  136  defining a front wall of the shell, a second section  138  defining a top wall of the shell, and a third section  140  which defines a back wall of the shell. To facilitate manual bending and folding of the second flap between its non-deployed position extending outwardly from the base  102  to its deployed position folded over the base  102 , a fold or score line  142  may be formed between the flap  132  and the base  102 . Another score or fold line  144  may be formed between the top wall section  138  and the back wall section  140 . Another fold or score line  146  may be formed between front wall section  136  and top wall section  138  of the second flap  132 . The second flap  132  is folded at these lines so as to create the cell structure which at least partially surrounds the head  12  of the medical instrument  10 , as illustrated in  FIGS.  2  and  3   . The shell is comprised of the sections  136 - 140  that wrap around the head  12  of the medical instrument  10  and cooperatively form with the base  102  a compartment that holds the head  12  of the medical instrument  10  therein. 
     A cutout  148  may be formed in the second flap  132 , such as in the top wall section  138 . This cutout  138  forms a window which can have multiple purposes. Similar to window  130  formed in the first flap  104 , this window  148  formed in the second flap  132  can facilitate the entry and exit and flow of the sterilant medium, which may be steam or ETO. Also, the window  148  allows for easy viewing and visual identification of the head  12  of the medical instrument  10 , which can provide information to the user as to the exact type of medical instrument which is being supported by the backer card  100 . While window  148  can be of various configurations and sizes in the top wall section  138 , preferably, the window  148  is of a configuration, size and placement, such as illustrated, wherein it occupies only a portion of the top wall  138  and is sufficiently spaced from the edges of the top wall  138  to reduce the chance of buckling of the card material during folding of the second flap  132 . 
     A locking mechanism retains the second flap  132  into a folded, deployed position over the base  102 . The locking mechanism comprises a first locking member detachable from the base and a second locking member formed in the second flap that lockingly engages the first locking member. The locking mechanism, and the first and second locking members, may take a variety of forms. 
     With reference to  FIGS.  1 - 4   , the first locking member comprises a wall  150  having a slot  152  formed therein. The wall  150  is generally co-planar with the base  102  until the backer card is assembled, wherein the wall  150  is partially detached from the base  102  and lifted upwardly. In this position, the front wall  136  of flap  132  and the first locking member wall  150  are disposed adjacent to one another. A wing  154  of section  136  of the flap  132  is bent outward and insertable into the slot  152  of the wall  150 , as illustrated in  FIGS.  2  and  4   , so as to lock the folded shell structure of the deployed second flap  132  to the base  102 . 
     With reference now to  FIGS.  5 - 8   , in this embodiment, the first locking member of the locking mechanism comprises a belt  156 . The belt  156  is attached to the base  102  and generally co-planar therewith. However, the belt  156 , which comprises an elongated strip, as illustrated, is partially detachable from the base  102  and raised upwardly and folded over at least a portion of the constructed and deployed flap  132 , such as over front wall  136  and top wall  138  so as to be inserted into slit  158  such that the belt  156  and the deployed strap  132  are locked into place relative to the base  102 . Score lines  160  and  162  may be formed in the belt  156  so as to facilitate the bending and folding of the belt  156  over walls  136  and  138  of the deployed second flap  132 . The slit  158  is formed within the second flap  132 , such as illustrated between the top wall section  138  and back wall section  140 . 
     The backer card  100  may include means for holding the shaft  14  of the medical instrument  10 , such that the shaft  14  will remain elevated and spaced apart from the base  102 . Such may include an eyelet flap  164  which is partially detachable from the base  102  and pivotable upwardly from the base  102 , as illustrated in  FIG.  2   . The eyelet flap  164  may include an aperture  166  or notch therethrough that receives the shaft  14  of the medical instrument  10  therein, as illustrated in  FIG.  3   . 
     With reference now to  FIGS.  5 - 8   , alternatively, or additionally, a notch  168  may be formed in the second flap  132 , such as in front wall section  136  that receives the shaft  14  of the medical instrument  10  therein. The notch  168  is open-ended and may be configured so as to have a narrower width or opening at an open end thereof leading to a larger opening, such that the shaft  14  is received in snap-fit relation to the notch  168  and so that the shaft  14  will remain in place within the notch  168 . 
     It is known in the industry to utilize sterilization indicators or integrators to confirm and visually indicate that sterilization has been complete and that the medical instrument  10  has been properly sterilized. Such may include autoclave tape or an indicator, in the form of an integrator card  20  which are designed to react to various variables of sterilization, including time, temperature, and/or steam. Temperature or steam sensitive chemicals may be layered between paper and aluminum foil or other materials on the card which melt or otherwise react during the sterilization cycle. Thus the user can quickly and easily determine if proper sterilization of the medical instrument  10  has taken place. The present invention may include a sterilization indicator card retainer formed in the base  102 . Such may be comprised of slits  170  and  172  forming small flaps and/or areas for the card to be inserted into and held onto the backer card  102  during the sterilization process. Corners or edges of the sterilization indicator or integrator card  20  may be inserted into the one or more flaps  170 , slits  172  or the like to hold it into place on the backer card  102 . 
     In a particularly preferred embodiment, the backer card  100  also includes a finger hold through which a user may insert one or more fingers to move or carry the backer card  100  in a safe and sterile manner. Such may include an aperture  174  formed in the base  102 , such as at one end thereof, through which the user may insert one or more fingers to hold and grasp the sterilization card  100  and the attached medical instrument  10 . Alternatively, or additionally, a finger hold member  176  may extend from the base  102 , such as an end thereof, and have an aperture  178  formed therethrough through which one or more fingers of the user may be inserted for the purpose of holding and carrying the backer card  100 . Such may be formed, as illustrated, at the end  134  of the backer card  102  and extending into the back wall section  140  of the second flap  132 , and detachably connected thereto such that as the flap  132  is lifted and folded into its deployed shell shape, the finger hold  176  remains extending outwardly from the base  102 , as illustrated. The finger holds may be used to carry the medical instrument  10  and backer card  100 , place them within a sterilization package, such as a peel pouch or the like or for use when removing the medical instrument  10  from the backer card  100 . 
     Although several embodiments have been described in detail for purposes of illustration, various modifications may be made without departing from the scope and spirit of the invention. Accordingly, the invention is not to be limited, except as by the appended claims.