Abstract:
Packaging and methods for packaging tools having a sharp or cutting edge, such as surgical tools, in which the tool is packaged under sterile conditions. The tool may be packaged first—at least partially—and in particular with its sensitive cutting edges and working surfaces packaged in a protective package. The protective package containing at least the cutting or working surfaces of the tool may then be secured in a fixed position in an outer blister pack, which may be sealed with a sealing film.

Description:
BACKGROUND 
       [0001]    1. Technical Field of the Invention 
         [0002]    This invention pertains generally to sterile plastic packaging for the storage of items having a cutting or sawing edge. More specifically, the invention includes a two-part package comprising a first protective package which holds the item and a second blister pack which holds the first package in a fixed position therein. 
         [0003]    2. Description of the Related Art 
         [0004]    The presently disclosed invention is described in connection with a surgical instrument such as an oscillating saw or a bone saw or the like is assumed as an example of a surgical instrument. The description of an oscillating saw with a sharp-edged serrated blade is thus to be understood only as an example without limiting the scope of the invention. 
         [0005]    In packaging sterile surgical tools, it is known that these surgical tools may be packaged in a polybag. The disadvantage of this type of packaging is that the sterile surgical tool, which may have sensitive cutting or sawing edges, can slip around unprotected in the interior of the polybag during shipping and handling of the package and may thus come in contact with the inside surfaces of the polybag. Microfine particles from the plastic packaging can therefore enter the blade area of the surgical tool in an unwanted manner. There is thus the risk during surgery that these particles—possibly invisible—may be introduced into the surgical wound, which could result in serious tissue irritation in the surgical area. 
         [0006]    In the past, there has not been an acknowledged method of sterile packaging of surgical tools in such a way that the package cannot be damaged even if it falls on the ground during shipping and handling. The object of the present invention is therefore to provide a package for, and a method for, packaging tools having a sharp or cutting edge such as, for example, surgical tools. The package and method of use thereof will make it possible to store tools having a sharp edge under sterile conditions so that they are free of contamination and damage, and ensures that the tools can be removed from the package in a sterile and undamaged condition when the package is opened. 
       SUMMARY 
       [0007]    The presently disclosed invention overcomes many of the shortcomings of the prior art by providing a two-part package, and method of use of such, which maintains a tool having a sharp or cutting edge securely within a first package which is then held securely within a second blister-pack package. In accordance with the disclosed invention, a tool is first packaged—at least partially—and in particular with its sensitive cutting edges and working surfaces in a (first) protective package and this protective package together with the surgical tool packaged therein is placed in a (second) blister pack, where it is held in a secure position and sealed with a sealing film after the position has been secured. 
         [0008]    This technical teaching yields the advantage of a two-step type of packaging which provides that the surgical tool with its sensitive blades and working edges is packaged in a first protective package, so that the sensitive parts of the surgical tool cannot come in contact with any plastic parts of the protective package. For this reason, a protective package is provided in the first step, its volume being designed so that the parts of the surgical tool that are sensitive to contact are held in a non-contact accommodation in the interior of the protective package. There is therefore no risk that the sensitive parts will come in contact with the plastic surfaces on the inside of the protective package and pick up microparticles in an undesirable manner. Such a protective package is designed so that the sensitive blades or working surfaces of the surgical tool cannot come in contact with the inside surfaces of the protective package even if the protective package drops to the ground. 
         [0009]    In a second step, it is provided that the surgical tool packaged in the protective package in this way is then placed in a blister pack and secured there in a fixed position. Due to the method of securing the tool in a fixed position in the blister pack, the surgical tool, which has already been packaged in the protective package, cannot slide back and forth in the blister pack. This could also result in microparticles being picked up in an undesirable manner. Securing the position of the protective package in the blister pack ensures that the surgical tool packaged in the protective package cannot come in contact with the walls of the blister pack along any of its surfaces to pick up unwanted microparticles there. 
         [0010]    This double packaging (protective package and blister pack) yields the additional advantage that even with improper or careless handling and shipping, there is no risk that the sensitive blades of the surgical tool might puncture the protective package or even break out of the blister pack because double packaging is provided. 
         [0011]    In a preferred embodiment of the invention it is provided that the fixed positioning of the surgical tool packaged in the protective package is provided only with respect to the protective package itself. This avoids any contaminating contact between the parts of the surgical tool which protrude out of the protective package and the blister pack. The unpackaged parts of the surgical tool protruding out of the protective package therefore do not come in contact with the surfaces of the blister pack. 
         [0012]    The packaging of the presently disclosed invention therefore provides a free-standing method for holding surgical tools in an inner protective package because only the protective package itself is secured in the outer blister pack and all the other parts of the surgical tool are free-standing in the blister pack and do not come in contact with the blister pack. 
         [0013]    The presently disclosed invention is not limited to accommodating a single surgical tool within a protective package in such a blister pack or to accommodating a single type of surgical tool in a protective package within a blister pack. That is, in certain embodiments various surgical tools may be packaged in the manner described herein, where each surgical tool is packaged in its own protective package and all the protective packages are secured in a fixed position in a blister pack. In this way, an entire set of the same or different surgical tools for a certain operation can be made available using a single blister pack. Thus, for example, two or three different saws, which are needed for a certain operation, may be accommodated in a single blister pack, with each surgical tool being packaged in its own protective package and all the protective packages being fixed in a secured position in the blister pack. 
         [0014]    The presently disclosed invention provides that only the sensitive (front) parts of the surgical tool may be enclosed by a protective package, and the other parts—for example, the shaft parts which are provided for connecting to a machine—remain unpackaged. This reduces costs because only a partial packaging is provided as the inner protective package for the surgical tool. To prevent the parts of the surgical tool that are not covered by the inner protective package from being contaminated by coming in contact with the inside surfaces of the outer blister pack, the invention provides that the outer blister pack holds only the protective package in a fixed position but not the unpackaged parts of the surgical tool. These unpackaged parts should therefore not come into contact with the walls of the outer blister pack. 
         [0015]    In a preferred embodiment, it is provided that the interior of the blister pack is either embodied as an air space or is filled with a protective gas. After placing the surgical tools held in the protective packages in the blister pack, the blister pack is either filled with a protective gas or remains filled with air and is then sealed at its top with a sealing film. This sealing film preferably consists of a sealable, airtight plastic material. Such sealing films have an adhesive coating, which leads to a complete and airtight seal of the interior of the blister pack after a suitable application of heat. 
         [0016]    The term “blister pack”, as used in the present patent application, is otherwise to be understood broadly. In a first embodiment of the invention, it is provided that the bottom part of the blister pack establishes a form-fitting receptacle to receive the protective package of the surgical tool. In this case, the top side of the blister pack may be provided with a smooth peripheral edge, which can be sealed with the sealing film. 
         [0017]    In another embodiment, it is provided that the blister pack is designed in two parts and consists of a top part, which has certain receptacles for form-fitting accommodation of parts of the protective package. The top part can be connected to the bottom part which likewise has receptacles for parts of the protective package. In this case, two molded parts (top part and bottom part) can be connected to one another in a connection area by sealing, adhesive bonding, welding or the like, for example. 
         [0018]    Such a blister pack preferably consists of a deep-drawable, gamma-radiatable plastic material. Likewise, this plastic material may be beta-radiatable, wherein both beta and gamma radiation may be used for sterilization, for example. The difference in the types of radiation lies in their ability to penetrate the material and in their dosing rate. To produce a sterile interior atmosphere inside the blister pack, it is provided that after complete airtight closure of the blister pack with the help of the sealing film or with the help of the attached to part at any subsequent point in time, sterility may be established by the fact that the blister pack is brought within the range of a beta- or gamma-radiation source. The inside of the blister pack and thus also the inside of the protective package which holds the surgical tool are sterilized. 
         [0019]    In comparison with the prior art, the invention has the advantage that the sensitive parts of the surgical tool are surrounded completely by the protective package and held at a distance (without contact) from the inside surfaces of the protective package, so that the sealing film or the top part is removed first when the blister pack is opened. The blister pack is opened under sterile conditions in the operating room. After opening the blister pack, the protective package with the surgical tool packaged therein can be removed from the blister pack by tearing open the sealing film. 
         [0020]    To this end, the invention provides that removal openings suitable for fingers are provided in the blister pack precisely on the side of the blister pack where the protective package is held. This ensures that the surgical tool packaged in the protective package may only be removed from the blister pack by gripping the protective package. 
         [0021]    This is an advantage over the prior art where it was known only that the surgical tool is accommodated in the region of the shaft in a fixed position in a package. This had the disadvantage that when opening the package the surgeon would grip the tool precisely on the end opposite the shaft, namely on the sharp, sensitive blade, which must be protected from contamination, and thus the surgeon might contaminate the blade or injure his glove to such an extent that particles would come in contact with the blade. This can in turn lead to serious surgical complications. There was also the risk that by gripping the cutting edges of the surgical tools while wearing gloves, the gloves might be damaged and the blade might come in contact with the surgeon&#39;s skin, which would thus compromise sterility in the operating field. 
         [0022]    The presently disclosed invention further provides that the removal openings in the blister pack may be placed in the area of the protective package and that the protective package surrounds precisely the surgical blades and working surfaces of the surgical tool that are to be protected, holding them at a distance so that there is no contact with package surfaces. 
         [0023]    This provides the advantage that the surgical tool is grasped by holding the protective package at the level of the packaged blade, so the surgeon can immediately insert the shaft, which is protruding out of the protective package into the respective machine. The machine may have a coupling fitting, for example, for the shaft of the surgical tool to couple with. The protective package may then be removed only after successful coupling of the shaft of the surgical tool. The machine can then be held in one&#39;s hand and the protective package subsequently removed. There is no danger that the surgeon&#39;s gloved hand might come into the region of the blade of the surgical tool because the opening in the protective package is from the rear (shaft end) of the surgical tool and not from the front, from the cutting end. 
         [0024]    The protective package is therefore removed from the shaft end just before the surgery, i.e., with the machine being held securely and with the surgical tool coupled, so there is no risk that the surgeon&#39;s gloved hand might enter the working or cutting range of the surgical tool. 
         [0025]    Another advantage of the invention is that the protective package need not be adapted to the shape of the surgical tool. The protective package is designed so that a plurality of different shapes of surgical tools, for example, bone saws, scalpels, cutting tools and the like can be accommodated with a gripping effect in a standardized protective package, where the common feature of this holder is that the sensitive cutting and working surfaces of the surgical tool accommodated in the protective package are held so that there is no contact with the inside wall of the protective package. The volume of the protective package is selected to be so large in comparison with the packaged volume of the surgical tool that the packaged parts cannot come in contact with the inside surfaces of the protective package even in free fall of the protective package to the ground. 
         [0026]    In a preferred embodiment, different surgical tools are therefore each held with a gripping effect in the protective package, eliminating the need for a form-fitting holder that would have to be adapted to the particular shape of the tool. That is, in a holder with a gripping effect, a variety of different surgical tools can be held in the protective package, regardless of their precise shape. 
         [0027]    There is thus the advantage that only the protective package need be adapted to the blister pack according to the invention in a secured position, so it is suitable for holding a plurality of different surgical tools because a standard blister pack based only on the type of protective package to be held may be used here but not based on the type of surgical tool to be secured. This results in a universal usability of the blister pack according to the invention. 
         [0028]    Thus a fully automatic packaging of large quantities of surgical tools in blister packs becomes possible for the first time because the blister pack must always be based only on securing the position of a universal protective package but not on different surgical tools. 
         [0029]    All the information and features disclosed in these documents, including the abstract, in particular the three-dimensional formation depicted in the drawings, make up the presently disclosed invention, inasmuch as they are novel individually or in combination in comparison with the prior art. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0030]    The invention is explained in greater detail below, illustrating only one type of embodiment. Additional features that are essential to the invention and advantages of the invention are derived from the drawings shown herein, which include: 
           [0031]      FIG. 1  illustrates a schematic view from above of an opened blister pack containing a protective package with a surgical tool packaged therein; 
           [0032]      FIG. 2  illustrates a top view of the arrangement from  FIG. 1 ; 
           [0033]      FIG. 3  illustrates the section through the arrangement according to  FIG. 1  and  FIG. 2 ; 
           [0034]      FIG. 4  illustrates the section through the arrangement according to  FIG. 2  as seen in the direction of the arrow IV-IV; 
           [0035]      FIG. 5  illustrates the section through the arrangement according to  FIG. 2  as seen in the direction of the arrow V-V; 
           [0036]      FIG. 6  illustrates the same diagram as that in  FIG. 3  except that it shows a detail according to  FIG. 7 ; 
           [0037]      FIG. 7  illustrates the detail from  FIG. 6  illustrating the engagement opening for removing the protective package. 
       
    
    
     DETAILED DESCRIPTION 
       [0038]    Referring now to the drawings,  FIGS. 1-7  illustrate embodiments of the packaging system of the presently disclosed invention. The figures illustrate in general a bottom shell  1  of a blister pack made of a deep-drawable plastic material. A safety container  13  may be inserted into the bottom shell in a secured position which is inserted into the interior  29  of bottom dish  1  of the blister pack. 
         [0039]    In the exemplary embodiment shown here, stop surfaces  21 , which cooperate with the respective stop surfaces on the outside wall of the protective container  13  are provided in the interior  29  of the bottom shell  1  of the blister pack, so that the protective container  13  is held in a fixed position in the bottom shell  1  without tilting or twisting. 
         [0040]    The protective container  13  in turn accommodates the surgical tool  15  to be protected, wherein the sensitive blade  14  of the tool  15  is accommodated in the protective container  13  at a distance from all the inside surfaces of the protective container  13  in a non-contact accommodation. This ensures that the blade  14  of the tool  15  will not come in contact with a plastic surface of the protective container  13 . 
         [0041]    The tool shaft  17  of the tool  15  protrudes out of the rear side of the protective container  13  and protrudes with play and while maintaining a distance (without contact) into the interior of the bottom shell  1 . Consequently, only the protective container  13  may be held in a secure position and the tool shaft  17  protruding out of the protective container  13  may be supported in a smaller assigned receiving opening  10  in the bottom shell  1 , while retaining a contact distance. The rear part of the tool shaft  17  may be held in a round receptacle opening  11  while retaining a contact distance. 
         [0042]    This ensures that the tool shaft  17  of the tool  15  accommodated in the protective container  13  will not come in contact with the material of the bottom shell  1  of the blister pack at any point and be unintentionally contaminated there. This is thus a free-standing support of the surgical tool, as is also apparent from  FIG. 6 . 
         [0043]    The bottom shell  1  has a top peripheral sealing face  19  and forms a pull strip  2  directed toward the front. The pull strip  2  may be connected to the remaining material of the bottom shell  1  as one piece of material. The sealing film  20  lies loosely over the pull strip  2  and can be pulled away there. It rests on the surrounding sealing face  19  and may be sealed there in an airtight manner. 
         [0044]    The surface  3  of the pull strip  2  sits below the plane of the sealing face  19 , so that the sealing film  20  can be gripped easily by hand in this area and pulled upward. 
         [0045]    The protective container  13  may be held in the larger receptacle opening  4  in the area of the interior  29  of the bottom shell  1  in a fixed position. The protective container has counter faces  22 , which cooperate with the respective stop faces  21  in the bottom shell  1 , to thereby hold the protective container  13  in the receptacle opening  4  of the bottom shell  1 , so that it is fixed in position and is free of tilting and twisting. 
         [0046]    This ensures that the protective container  13  can be removed from the bottom shell  1  when the sealing film  20  is torn off. A handle opening  6  in the bottom shell  1 , which may be arranged in the area of the pull strip  2  and maintains the distance at the end face, can be used for removal of the protective container  13  from the bottom shell  1 . 
         [0047]    According to  FIG. 7 , the protective container  13  is removed in the direction of the arrow  31  by gripping with the finger  25  on one hand into the handle. The hand thus holds the protective container  13  securely and the sensitive blade  14  of the tool  15  is still held free-standing and in a secured position in the protective container  13 . In this situation, the protective container  13  is gripped and the tool shaft  17  is supplied to a tool (not shown in detail here) with its coupling receptacle  18 , which establishes a coupling with the tool shaft  17 . 
         [0048]    The protective container  13  may be removed only when the tool  15  has been coupled by the tool shaft  17  to the machine while still packaged. This is done in a sterile atmosphere because the sealing film  20  is removed from the blister pack according to the invention only in the sterile operating room. 
         [0049]      FIGS. 4 and 5  show that the bottom side of the protective container  13  is a distance away from the bottom  7  of the bottom shell  1 , and there are spacer ribs  30 , which maintain the protective container  13  with respect to the bottom of the bottom shell  1 . 
         [0050]      FIG. 1  shows that the side edges  8  in the area of the protective container  13  form the stop faces for the holder in the area of the larger receptacle opening  4 . 
         [0051]    The closure  23  of the protective container  13  established by catch means is held in a clearance, namely in a receptacle opening  9 , to also prevent the closure  23  from coming in contact with the container surfaces of the bottom shell  1 . 
         [0052]    A folding hinge  24 , preferably embodied as a film hinge, is integrally molded on the side of protective container  13  opposite the closure  23 . 
         [0053]    The tool  15  to be protected is held in the protective container  13  by the fact that the tool shaft  17  is enclosed with a gripping effect between the top and bottom sides by two elastomeric holding elements  27 . This is illustrated in a sectional view in  FIG. 5 . 
         [0054]    However, the end of the tool shaft  17  pointing in the direction of the front end (blade  14 ) is free of any contact with surfaces of the blister pack, so that the blade  14  protrudes completely freely into the interior of the protective container  13  without any contact, as shown in  FIG. 4 . Thus the interior  28  of the protective container  13  is held without contact with the blade  14 . 
         [0055]      FIG. 5  shows that the protective container  13  can be carried and supported in its rear part by molded ribs  30  on the bottom  7  of the bottom shell  1 . This shaping of the bottom shell is designed with a receptacle opening  4 , so that the receptacle opening  4  surrounds the protective container  13  at least partially in a form-fitting manner, so that only the protective container  13  is accommodated in a fixed position in the bottom shell  1 , but the tool  15  accommodated in the protective container  13  does not come in contact with any surface of the bottom shell  1 . 
         [0056]    This creates a blister pack which is opened only in the sterile operating room, where the protective container  13  is gripped with a finger  25 , while the sensitive blade  14  is protected from contact and the tool  15 , which is still packaged in the protective container, is inserted into a machine and coupled there. Only then is the protective container  13  removed just before the tool  15  is used for an operation. 
       LEGEND TO THE DRAWINGS 
       [0000]    
       
           1  Bottom shell 
           2  Pull strip 
           3  Surface (of  3 ) 
           4  Receptacle opening (large) 
         
           5 
         
           6  Gripping opening 
           7  Bottom 
           8  Side edge 
           9  Receptacle opening (small) 
           10  Receptacle opening (small) 
           11  Receptacle opening (round) 
         
           12 
         
           13  Protective container 
           14  Blade 
           15  Tool 
           16  Holding part 
           17  Tool shaft 
           18  Coupling receptacle 
           19  Sealing face 
           20  Sealing film 
           21  Stop face 
           22  Counter face 
           23  Closure 
           24  Folding hinge 
           25  Finger 
         
           26 
         
           27  Holding element 
           28  Interior (of  13 ) 
           29  Interior (of  1 ) 
           30  Molded rib 
           31  Direction of arrow