Patent Publication Number: US-2011064336-A1

Title: Medical Instrument Sterilization Pouch

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     I hereby claim benefit under Title 35, United States Code, Section 120 of U.S. patent application Ser. No. 11/622,942 filed Jan. 12, 2007. This application is a continuation of the 11/622,942 application. The 11/622,942 application is currently pending. The 11/622,942 application is hereby incorporated by reference into this application. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not applicable to this application. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to sterilization pouches and more specifically it relates to a medical instrument sterilization pouch for efficiently bagging hinged instruments. 
     2. Description of the Related Art 
     Any discussion of the related art throughout the specification should in no way be considered as an admission that such related art is widely known or forms part of common general knowledge in the field. 
     Sterilization pouches have been in use for years. Typically, when in a medical, dental or other similar environment it is necessary to keep all the instruments in pouches prior to use. The pouches effectively serve to prevent germs or other harmful toxins from coming in contact with the instruments when the instruments are not being used. The instruments are also generally sterilized prior to being inserted into the pouch or sterilized while inserted within the pouch. 
     Sterilization pouches are manufactured from many different materials, sizes and with many different sealing mechanisms. Although, one universal feature that generally exists in all sterilization pouches is that the sterilization pouches are generally rectangular in shape. This poses a problem with respect to hinged instruments, such as but not limited to orthodontic pliers and surgical pliers in that the hinged instruments cannot adequately fit on their respective tool racks (i.e. pliers rack) once the hinged instruments are in the pouch. Because of the general lack of efficiency and practicality in the prior art there is the need for a new and improved medical instrument sterilization pouch for efficiently bagging hinged instruments. 
     BRIEF SUMMARY OF THE INVENTION 
     The general purpose of the present invention is to provide a medical instrument sterilization pouch that has many of the advantages of the sterilization pouches mentioned heretofore. The invention generally relates to a sterilization pouch which includes a sealable inner space for receiving one or more medical instruments, a preferred instrument being hinged pliers. The pouch is generally comprised of first and second layers, the layers being sealed around a peripheral edge except a separation in the seal to form an opening for accessing the inner space and a flap for closing the opening. The pouch has an upper portion and a first and second lower portion extending therefrom, the upper portion being comprised of a vertical length just as long or longer than the lower portions to allow for insertion and removal of the instrument through the opening, wherein the opening is along the peripheral edge of the upper portion. A recessed portion separates the first and second lower portions, such as to permit the inner space to connect the first and second lower portions only through the upper portion. 
     There has thus been outlined, rather broadly, some of the features of the invention in order that the detailed description thereof may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional features of the invention that will be described hereinafter and that will form the subject matter of the claims appended hereto. 
     In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction or to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of the description and should not be regarded as limiting. 
     An object is to provide a medical instrument sterilization pouch for efficiently bagging hinged instruments. 
     Another object is to provide a medical instrument sterilization pouch that accommodates a variety of different style hinged instruments. 
     An additional object is to provide a medical instrument sterilization pouch that may be utilized with non-hinged instruments. 
     A further object is to provide a medical instrument sterilization pouch that allows the hinged instruments to be placed on their respective holding racks (i.e. pliers rack) after the hinged instruments are bagged. 
     Another object is to provide a medical instrument sterilization pouch that includes a durable outer material to prevent puncture by the instrument. 
     Another object is to provide a medical instrument sterilization pouch that mimics the shape and size of the medical instruments utilized thus producing less environmental and biological waste. 
     Other objects and advantages of the present invention will become obvious to the reader and it is intended that these objects and advantages are within the scope of the present invention. To the accomplishment of the above and related objects, this invention may be embodied in the form illustrated in the accompanying drawings, attention being called to the fact, however, that the drawings are illustrative only, and that changes may be made in the specific construction illustrated and described within the scope of the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various other objects, features and attendant advantages of the present invention will become fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the several views, and wherein: 
         FIG. 1  is an upper perspective view of the present invention in use and positioned upon a tool rack. 
         FIG. 2  is a front view of the present invention. 
         FIG. 3  is an upper perspective view of the present invention with a medical instrument partially inserted within the pouch. 
         FIG. 4  is an upper perspective view of the present invention with a medical instrument inserted within the pouch. 
         FIG. 5  is an upper perspective view of the present invention with a medical instrument inserted within the pouch and the flap sealed upon the pouch. 
         FIG. 6  is a sectional view taken along lines  6 - 6  of  FIG. 2 . 
         FIG. 7  is a front view of a pouch illustrating a first step in a first example of manufacturing the present invention. 
         FIG. 8  is a front view of a pouch illustrating a second step in the first example of manufacturing the present invention. 
         FIG. 9  is a front view of a pouch illustrating a first step in a second example of manufacturing the present invention. 
         FIG. 10  is a front view of a pouch illustrating a second step in the second example of manufacturing the present invention. 
         FIG. 11  is a front view of a first alternative embodiment of the present invention. 
         FIG. 12  is a front view of a second alternative embodiment of the present invention. 
         FIG. 13  is a front view of a third alternative embodiment of the present invention. 
         FIG. 14  is a front view of a fourth alternative embodiment of the present invention. 
         FIG. 15  is a front view of a fifth alternative embodiment of the present invention. 
         FIG. 16  is a front view of a sixth alternative embodiment of the present invention. 
         FIG. 17  is a front view of a seventh alternative embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     A. Overview. 
     Turning now descriptively to the drawings, in which similar reference characters denote similar elements throughout the several views,  FIGS. 1 through 17  illustrate a medical instrument sterilization pouch  10 , which comprises a pouch  20  including a first layer  30  and a second layer  40 , wherein the first layer  30  and/or the second layer  40  are comprised of a gas permeable material and wherein the first layer  30  is attached to the second layer  40  via an outer seal  42  substantially surrounding an outer perimeter of the first layer  30  and the second layer  40 . The layers  30 ,  40  are sealed around a peripheral edge except a separation in the seal  42  to form an opening  29  for accessing the inner space and a flap  50  for closing the opening  29 . 
     The pouch  20  includes a first lower portion  21  and a second lower portion  23 , wherein the first lower portion  21  is separated from the second lower portion  23  and wherein the first lower portion  21  and the second lower portion  23  form a recessed portion  27  between thereof. The upper portion  25  is comprised of a vertical length just as long or longer than the lower portions  21 ,  23  to allow for insertion and removal of the instrument  12  through the opening  29 , wherein the opening  29  is along the peripheral edge of the upper portion  25 . The pouch  20  preferably receives a medical instrument  12  (e.g. surgical pliers), wherein the medical instrument  12  is sterilized within the pouch  20  and is then positioned upon a respective tool rack  14  (i.e. pliers rack). 
     B. Pouch. 
     The pouch  20  is preferably comprised of a configuration to hold hinged medical instruments  12 , such as but not limited to orthodontic pliers, surgical pliers, tweezers and scissors. The pouch  20  also preferably adequately holds non-hinged medical instruments  12 , such as but not limited to inspection mirrors, dental picks, dental scalers and spatulas, wherein the non-hinged medical instruments  12  are simply inserted into the pouch  20  in a crossed manner. It is also appreciated that the pouch  20  may hold various other tools or equipment not associated with medical use. The pouch  20  preferably mimics the shape of the medical instrument  12 , thus requiring the minimal amount of packaging for each medical instrument  12 . 
     The pouch  20  includes a first layer  30  and a second layer  40  as shown in  FIG. 6 . The first layer  30  and the second layer  40  are preferably both comprised of a gas permeable material. The first layer  30  and the second layer  40  are further impermeable to micro-organisms or toxins. The first layer  30  and the second layer  40  are further preferably comprised of a material resistant enough to withstand both steam and dry heat sterilization cycles. The first layer  30  and the second layer  40  may further be comprised of various materials, such as but not limited to nylon films, polypropylene films, polyethylene films, polyester polypropylene pellicles, blends of medical grade paper or a combination of two or more materials. The first layer  30  and the second layer  40  are further preferably comprised of a transparent material so as to easily view the medical instrument  12  within the pouch  20 . The first layer  30  and the second layer  40  may also include chemical, steam and heat activated indicators. The indicators are preferably painted on the first layer  30  or the second layer  40 . 
     The first layer  30  and the second layer  40  may be comprised of a plurality of different shapes and sizes, wherein each of the configurations of the first layer  30  and the second layer  40  forms a recessed portion  27  to receive the legs of a medical instrument  12  as illustrated in  FIGS. 1 through 17 . The first layer  30  and the second layer  40  are further preferably comprised of substantially similar configurations. 
     The first layer  30  and the second layer  40  are preferably attached substantially near an outer perimeter of the first layer  30  and the second layer  40  via an outer seal  42  as shown in  FIGS. 1 through 5 . The outer seal  42  extends substantially across an entire perimeter of the first layer  30  and the second layer  40 , wherein the outer seal  42  leaves room for an opening  29  along at least one outer edge to access the inner space between the first layer  30  and the second layer  40 . 
     The pouch  20  includes the first lower portion  21 , the second lower portion  23  and the upper portion  25  opposite the first lower portion  21  and the second lower portion  23 . The first lower portion  21  and the second lower portion  23  are preferably separably formed, wherein each lower portion preferably receives a respective leg of a medical instrument  12 . In the case of the medical instrument  12  being comprised of a medical, hinged pliers, the head of the pliers  12  is received by the upper portion  25 , the first leg of the pliers  12  is received by the first lower portion  21 , and the second leg of the pliers  12  is received by the second lower portion  23  as illustrated in FIGS.  1  and  3 - 5 . 
     The recessed portion  27  is formed between the first lower portion  21  and the second lower portion  23  as shown in  FIGS. 1 through 5 . The recessed portion  27  is preferably positioned upon a respective tool rack  14  (i.e. pliers rack) when storing or sterilizing the medical instrument  12  (i.e. surgical pliers) within the pouch  20  as illustrated in  FIG. 1 . Sterilizing the surgical pliers or other hinged instruments  12  upon the pliers rack  14  prevents the pouches  20  from being stacked upon one another, wherein stacking multiple medical instruments  12  upon one another may prevent the sterilization substance from coming in contact with the entire medical instrument  12 . Utilizing the tool rack  14  allows the pouches  20  to be spaced adequately apart and thus allows the sterilization substance to effectively contact all surfaces of the medical instrument  12 . 
     The recessed portion  27  is preferably comprised of a triangular shaped configuration. An apex of the recessed portion  27  preferably extends upwardly toward the upper portion  25  as shown in  FIGS. 1 through 5 . It is appreciated that the recessed portion  27  may also be comprised of a substantially semi-circular or oval shaped configuration as illustrated in  FIGS. 16 and 17 , or may have a flat upper edge as illustrated in  FIG. 15 . It is further appreciated that the recessed portion  27  may be comprised of a plurality of various configurations all which substantially separate the first lower portion  21  from the second lower portion  23  as illustrated in  FIGS. 11  through  15 . The recessed portion  27  is adapted to permit the inner space to connect the first lower portion  21  and the second lower portion  23  through the upper portion  25  and to restrict the inner space from connecting the first lower portion  21  directly to the second lower portion  23 . 
     The first lower portion  21  and the second lower portion  23  preferably substantially mirror each other as shown in  FIG. 2 . The ends of the first lower portion  21  and the second lower portion  23  may also be comprised of a plurality of configurations, such as but not limited to flat, inclined or rounded as illustrated in  FIGS. 2 and 11  through  17 . 
     The upper portion  25  extends upwardly from lower portions  21 ,  23  and preferably receives the head of the medical instruments  12  as illustrated in  FIGS. 1 ,  4  and  5 . The upper portion  25  may also be comprised of a plurality of configurations, as illustrated in  FIGS. 11 through 17 . The upper portion  25  may include at least one tapered edge or a bottle neck configuration to better conform to the overall shape of the medical instrument  12  as illustrated in  FIG. 2 . The inside of the pouch  20  is preferably fluidly connected from the first lower portion  21  to the upper portion  25  to the second lower portion  23 . The inside of the first lower portion  21  is preferably substantially fluidly sealed from the inside of the second lower portion  23  via the recessed portion  27 . The upper portion  25  may be triangular shaped such as illustrated in  FIGS. 2 and 14 , rectangular shaped such as illustrated in  FIG. 8 , or be comprised of other polygonal or curved shapes, such as illustrated in FIGS.  13  and  15 - 17 . 
     The opening  29  is preferably formed along at least one edge of the upper portion  25  of the pouch  20  as shown in  FIGS. 1 through 5 , wherein the outer seal  42  does not extend across the perimeter of the first layer  30  and the second layer  40  along the opening  29 . The opening  29  is further preferably positioned along a tapered, angular end of the upper portion  25  as illustrated in  FIGS. 1 through 5 . The opening  29  allows access to the inside of the pouch  20  between the first layer  30  and the second layer  40 . The opening  29  is also preferably large enough to allow the hinged instrument to be inserted adequately into the pouch  20 . The opening  29  may also be formed along the top edge of the upper portion  25 , such as in the rectangular embodiment of  FIG. 8  and thus be oriented horizontally. 
     The vertical length of the upper portion  25  is also preferably just as long or longer than the first lower portion  21  and also just as long or longer than the second lower portion  23  thus being able to adequately permit insertion of the medical instrument  12  within the pouch  20  through the opening  29  of the upper portion  25 . Further, in some embodiments, the upper portion  25  is longer than the first lower portion  21  and is longer than the second lower portion  23 . For example, the embodiment of the pouch  20  in  FIG. 8  clearly illustrates that the upper portion  25  is longer in length than the first lower portion  21  and the second lower portion  23 . The upper portion  25  is also illustrated as just as long or longer than the lower portions  21 ,  23  in  FIGS. 2 and 11  through  17 . 
     C. Flap. 
     The flap  50  covers the opening  29  after the medical instrument  12  has been inserted within the pouch  20  to prevent contaminants and toxins from coming into contact with the medical instrument  12 . The flap  50  preferably extends along an entire length of the opening  29  as shown in  FIGS. 1 through 5 , wherein the opening  29  extends along an edge of the upper portion  25 . The flap  50  is further preferably parallel with the opening  29  and thus may extend along an angular edge as illustrated in  FIG. 2 , a horizontal edge as illustrated in  FIG. 8 , or partially along a vertical edge as illustrated in  FIGS. 16 and 17 . 
     The flap  50  includes a first flange portion  52  and a second flange portion  54 . The first flange portion  52  is preferably attached to the upper portion  25  and is substantially parallel with the opening  29 . The second flange portion  54  preferably extends outwardly from the first flange portion  52  as shown in  FIG. 6 . The second flange portion  54  further preferably extends outwardly from the upper portion  25 . The second flange portion  54  is also preferably parallel with the opening  29  as illustrated in  FIG. 6 . 
     The second flange portion  54  preferably includes a sealing member  56  extending across a longitudinal axis of the second flange portion  54  as shown in  FIG. 4 . The sealing member  56  is positioned about an upper side of the second flange portion  54  of the flap  50 . The sealing member  56  is further preferably comprised of an adhesive material so as to adequately stick to the upper side of the first layer  30 . An outer layer  58  is preferably removably attached to the upper side of the sealing member  56  to prevent foreign substances from attaching to the sealing member  56  when not in use. 
     The sealing member  56  and the outer layer  58  function in a similar manner to a sticker, wherein the backing of the sticker must be removed to attach the sticky surface to an object. It is appreciated that the opening  29  of the pouch  20  may be sealed utilizing a plurality of various manners rather than the preferred method, such as but not limited to a self-sealing extremity or a thermo-sealing blade. 
     D. Manufacture of Invention. 
     The present invention may be manufactured in various manners as illustrated in  FIGS. 7 through 11 . A first example of a way to manufacture the present invention involves utilizing a standard rectangular pouch  20  as illustrated in  FIGS. 7 and 8 . A wedge is cut out of the pouch  20  from a substantially center bottom edge of the pouch  20  as illustrated by the cutting line  60  in  FIG. 7 . The wedge is preferably comprised of a substantially triangular shaped configuration. The wedge is then removed from the bottom of the pouch  20 , thus forming a first lower portion  21 , a second lower portion  23  and a recessed portion  27  between thereof. The perimeter of the recessed portion  27  is then sealed to prevent any microorganisms or toxins from entering the inside of the pouch  20  via the recessed portion  27 . 
     A second example of a way to manufacture the present invention is illustrated in  FIGS. 9 and 10 . A quadrilateral shaped hole is first cut through a substantial center of the sheet as illustrated by the cutting line  60  in  FIG. 9 . The sheet is preferably comprised of a pouch  20  material. The quadrilateral shaped hole is preferably cut, wherein each opposing corner perpendicularly faces an outer edge of the sheet as illustrated in  FIG. 9 . The quadrilateral shaped hole is then removed from the sheet, thus forming a hole in the center of the sheet. The sheet is then folded in the middle as illustrated by the folding line  61  in  FIG. 9 . The opposing ends of the sheet are thus joined and form a pouch  20  as shown in  FIG. 10 . The pouch  20  may then be sealed around the outer perimeter of the pouch  20 . An opening  29  is also preferably left unsealed to allow insertion of a medical instrument  12 . It is appreciated that the present invention may be manufactured in a plurality of manners other than the described manners above. 
     E. In Use. 
     In use, the medical instrument  12  (i.e. surgical pliers) is first inserted within the pouch  20  by inserting the handles or legs of the medical instrument  12 . Each respective leg is inserted within the respective lower portion  21 ,  23  of the pouch  20  and the head of the medical instrument  12  is inserted within the upper portion  25  of the pouch  20 . When the medical instrument  12  is adequately positioned within the sealed pouch  20  the medical instrument  12  may be sterilized via various techniques, such as but not limited to steam sterilization. It is appreciated that the medical instrument  12  may be sterilized in a plurality of manners and also before insertion into the pouch  20 . 
     The outer layer  58  of the flap  50  is then removed thus revealing the sealing member  56 . The second flange portion  54  is then folded over the opening  29  of the pouch  20  and the sealing member  56  is attached to the upper surface of the first layer  30  thus sealing the medical instrument  12  within the pouch  20 . The medical instrument  12  may now be positioned upon the respective tool rack  14  (i.e. pliers rack). When the user is ready to utilize the medical instrument  12  the above process is simply reversed. The sealed pouch  20  can also be opened by utilizing a scissors to cut open the pouch  20 . In addition, a slit  44  anywhere along the non-sealed periphery of the pouch  20 , as shown in  FIG. 2 , would allow the operator to tear open the pouch  20  with their fingers. 
     Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar to or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described above. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety to the extent allowed by applicable law and regulations. In case of conflict, the present specification, including definitions, will control. The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof, and it is therefore desired that the present embodiment be considered in all respects as illustrative and not restrictive. Any headings utilized within the description are for convenience only and have no legal or limiting effect.