Abstract:
The package ( 1 ) for a surgical mesh ( 100 ) comprises:
       a receiving member ( 2 ) configured and dimensioned to receive at least one surgical mesh ( 100 ), and   a covering member ( 3 ) configured and dimensioned to cover the said at least one surgical mesh ( 100 ) maintaining with the receiving member ( 2 ) the surgical mesh ( 100 ) in a substantially flat position, and   a gas channelling network interposed between the said receiving member ( 2 ) and the said covering member ( 3 ) configured to channel a sterilization gas within the at least one surgical mesh ( 100 ).

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims benefit of and priority to European Patent Application Serial No. EP15305621.3 filed Apr. 23, 2015, the disclosure of the above-identified application is hereby incorporated by reference in its entirety. 
       TECHNICAL FIELD 
       [0002]    The present invention relates generally to a package for a surgical mesh. 
       BACKGROUND OF THE RELATED ART 
       [0003]    Surgical meshes used for wall reinforcement, for example for the abdominal wall, are widely used in surgery. These surgical meshes are intended to treat, for example, hernias by temporarily or permanently filling a tissue defect. These surgical meshes are made generally from a surgical biocompatible textile and can have a number of shapes, for example rectangular, circular or oval, depending on the anatomical structure to which they are to adapt. The surgical mesh is generally flat and may vary in dimensions, from for example 5×10 cm up to 30×50 cm, depending on the size of the defect to be treated. 
         [0004]    Before being packaged as a commercial product and shipped to hospitals or end-users, the surgical mesh has to be sterilized to prevent contamination to the patient body in which it is intended to be implanted. 
         [0005]    Gas sterilization is commonly used in the medical field and surgical meshes are usually sterilized by means of ethylene oxide (EtO) gas. 
         [0006]    The sterilization process generally requires the immersion of the surgical mesh in ethylene oxide for a time sufficient for the gas to sterilize the surgical mesh. For handling purposes, the surgical mesh is usually inserted into a handling pouch before being submitted to the sterilization process. 
         [0007]    The handling pouch is provided with a window made of a material which is impervious to contamination by microorganisms, bacteria and/or a biologically active substance which may come into contact with the pouch while it is being handled, while at the same time remaining permeable to a sterilization gas such as for example ethylene oxide. Such a material is for example a nonwoven made of filaments of a high density polyethylene bound together by heat and pressure, such as a product sold by the Du Pont de Nemours under the trademark “Tyvek®”. The surgical mesh to be sterilized is therefore humidified by exposure to water vapor, inserted into a “Tyvek®” pouch and submitted to ethylene oxide gas for sterilization. 
         [0008]    However, it may happen, in particular for large surgical meshes, that the ethylene oxide gas may not reach the entire surface of the surgical mesh and/or does not diffuse in the surgical mesh a sufficiently efficient manner when the surgical mesh is first packaged in a pouch with a “Tyvek®” window. This proves to be a problem as it is desirable that sterilization is completed to a high degree on the entire surface of the surgical mesh. 
         [0009]    Furthermore, in order to proceed to ethylene oxide sterilization, the surgical mesh must be previously humidified. The larger the mesh, the more humid the mesh will be after the sterilization step. In addition, because of its intrinsic nature, the surgical mesh is subject to moisturization. Moisturization has to be avoided during transportation and storage so as to maintain optimal dry conditions of the surgical mesh at the moment of its use. 
       SUMMARY OF THE INVENTION 
       [0010]    In this technical context, it would be desirable to provide a packaging for a surgical mesh allowing an efficient ethylene oxide gas sterilization of all surgical meshes, whatever their size, that would prevent humidity of ambient air to permeate through the packaging, and that would also favour drying of the surgical mesh during storage and transportation. 
         [0011]    The present invention relates to a package for a surgical mesh comprising
       a receiving member configured and dimensioned to receive a surgical mesh, and   a covering member configured and dimensioned to cover the said at least one surgical mesh maintaining with the receiving member the surgical mesh in a substantially flat position, and   a gas channelling network interposed between the said receiving member and the said covering member configured to channel a sterilization gas within the surgical mesh.       
 
         [0015]    Thus, the invention makes it possible to maintain a surgical mesh in a substantially flat position and to bring a sterilizing gas in the entire surface of the mesh. This proves to be a great advantage for large surgical meshes, which tend to be partially sterilised using prior art sterilizing techniques. 
         [0016]    In a embodiment of the invention, the receiving member and the covering member define at least one gas diffusing compartment connected to the said gas channelling network. 
         [0017]    In an embodiment of the invention, the covering member includes at least one cut off portion allowing a large exposure to a sterilizing gas and a large exposure for humidity absorption by a desiccant agent. 
         [0018]    In an embodiment, the receiving member comprises a resting rib and an inner wall configured to receive the at least one surgical mesh and the covering member comprises at least one resting rib and an inner wall configured to maintain the at least one surgical mesh between the said resting ribs and to define the at least one gas diffusing compartment for a sterilizing gas. 
         [0019]    In an embodiment, the receiving member comprises at least one groove and the covering member comprises at least one groove defining with at least one groove of the receiving member a channel for a sterilizing gas. 
         [0020]    In an embodiment, the receiving member and/or the covering member comprise at least one transverse resting ribs forming at least two diffusing compartments. 
         [0021]    In an embodiment, the receiving member and the covering member include peripheral rim provided with at least one locking pin and at least one corresponding locking opening. 
         [0022]    In an embodiment, the peripheral rim includes a series of locking toothing. 
         [0023]    In an embodiment, at least one of the receiving member and of the covering member includes a cavity configured to receive a capsule of desiccant material. 
         [0024]    In an embodiment, the receiving member and the covering member have a substantially rectangular shape. 
         [0025]    In an embodiment, the covering member includes at least two cut off portions. 
         [0026]    In an embodiment, the covering member includes a central portion and two lateral portions extending from the central portion. 
         [0027]    In an embodiment, the covering member includes a hinge allowing access to the surgical mesh. 
         [0028]    In an embodiment, the hinge is formed by a weakened line. 
         [0029]    In an embodiment, the hinge is positioned at the junction the central portion and the lateral portion. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0030]    The foregoing objects and advantages of the present invention will become apparent from the reading of the following description in connection with the accompanying drawings, in which: 
           [0031]      FIG. 1  includes a perspective view of a package according to an embodiment of the invention; 
           [0032]      FIG. 2  includes a perspective view of a receiving member of the embodiment of  FIG. 1 ; 
           [0033]      FIG. 3  includes a perspective view a the receiving member with a surgical mesh; 
           [0034]      FIGS. 4 and 5  include perspective views of a covering member; 
           [0035]      FIG. 6  includes an exploded view of another embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0036]    Reference will now be made to the drawings wherein like structures are provided with like reference designations. 
         [0037]    Turning to  FIG. 1 , a package  1  for a substantially rectangular mesh is shown in an perspective view. 
         [0038]    Package  1  includes a receiving member  2  and a covering member  3 . In the illustrated embodiment of  FIG. 1 , the package  1  is shown as rectangular; however, the package  1  may be of any suitable shape for receiving a surgical mesh. 
         [0039]    The surgical mesh  100  can be seen in  FIG. 1 or 3 . 
         [0040]    The receiving member  2  has a generally planar shape. In the illustrated embodiment, the receiving member  2  comprises a series of resting ribs  4  protruding from an inner panel  5 . 
         [0041]    As depicted on  FIG. 2 , the receiving member  2  is thus provided with transverse ribs  4  and longitudinal ribs  4  which divide the inner panel  5  into diffusing compartments  8  as will be explained later. 
         [0042]    In the embodiment of  FIGS. 1 and 2 , the receiving member  2  is provided with four transverse resting ribs  4  and two longitudinal resting ribs  4 , which define three diffusing compartments  8 . 
         [0043]    The resting ribs  4  include at least one groove  9 . In the embodiment of  FIGS. 1 to 3 , the resting ribs  4  are provided with a series of grooves  9  spaced out at regular intervals. 
         [0044]    In embodiments, the inner wall  5  can be provided with strengthening ribs  11 . 
         [0045]    The receiving member  2  further includes a peripheral rim  12 . 
         [0046]    Along each length of the receiving member  2 , the peripheral rim  12  includes a series of locking toothing  13 . 
         [0047]    Along each width of the receiving member  2 , the peripheral rim  12  is provided with a locking pin  14  and a locking opening  15 . The peripheral rim  12  can also include one or more grooves  16 . 
         [0048]    Turning to  FIGS. 4 and 5 , a covering member  3  is shown. 
         [0049]    The covering member  3  has a generally planar shape. The covering member  3  has a substantially planar shape and is comprised of a central portion  20  and of two lateral portions  30  extending from the central portion  20  forming substantially a H. As can be seen on  FIG. 4 , the covering member  3  includes two symmetrical cut off portions  40 . 
         [0050]    In the illustrated embodiment, the covering member  3  comprises a series of resting ribs  4  protruding from an inner panel  5 . 
         [0051]    As depicted on  FIG. 5 , the covering member  3  is thus provided with transverse ribs  4  and longitudinal ribs  4 , which define with the inner panel  5  diffusing compartments  8 . 
         [0052]    In the embodiment of  FIGS. 4 and 5 , the covering member  3  is provided with two transverse resting ribs  4  and two longitudinal resting ribs  4 , which define a diffusing compartment  8  in each lateral portion  30 . 
         [0053]    The resting ribs  4  include at least one groove  9 . In the embodiment of  FIGS. 4 and 5 , the resting ribs  4  are provided with a series of grooves  9  spaced out at regular intervals. 
         [0054]    In embodiments, the inner wall  5  can be provided with strengthening ribs  11 . 
         [0055]    The covering member  3  further includes a peripheral rim  12 . 
         [0056]    Along each length of the covering member  3 , the peripheral rim  12  includes a series of locking toothing  13 . 
         [0057]    Along each width of the receiving member  3 , the peripheral rim  12  is provided with a locking pin  14  and a locking opening  15 . The peripheral rim  12  can also include one or more grooves  16 . 
         [0058]    The central portion  20  can include a cavity  22  provided with three retaining tabs  23 . 
         [0059]    In an embodiment, the covering member  3  includes two weakened line  25  to form a hinge at the junction of the central portion  20  with each of the lateral portions  30 . 
         [0060]    The surgical mesh  100  is placed onto the receiving member  2  as can be seen on  FIG. 3 . The surgical mesh  100  seats on the resting ribs  4  and is surrounded by the peripheral rib  12 . 
         [0061]    The covering member  3  is placed above the receiving member  4  and is locked onto the receiving member  2 . The locking pins  14  of the covering member  3  are engaged into the corresponding openings  15  of the receiving member  2 . The locking toothing  13  of the receiving member  2  engage into the locking toothing of the covering member  3 . 
         [0062]    The surgical mesh  100  is thus interposed between the receiving member  2  and the covering member  3  and is maintained in a substantially flat position. The surgical mesh  100  is maintained between the resting ribs  4  of the receiving member  2  and the resting ribs  4  of the covering member  3 . 
         [0063]    It can be noted that, within the package  1 , the gap between the resting ribs  4  of the receiving member  2  and the resting ribs  4  of the covering member  3  can be in the area of 1 mm while the surgical mesh  100  thickness can be in the area of 0.6 mm. 
         [0064]    When positioned in the package  1 , the surgical mesh  100  is thus maintained along the resting ribs  4 ; the part of the surgical mesh  100  which is not directly interposed between the resting ribs  4  of the receiving member  2  and of the covering member is received in the diffusing compartments  8  where the surgical mesh  100  is free from contact with the package. 
         [0065]    The surgical mesh  100  positioned in the package  1  may then be sterilized by immersion in a sterilizing solution of gas including ethylene oxide. 
         [0066]    The sterilizing gas can flow within the package  1  and diffuses into the surgical mesh  100  through the cut off portion  40  and through the grooves  9  provided in the resting ribs  4 . The entire surface of the surgical mesh  100  is thus exposed to the sterilizing gas. 
         [0067]    After sterilization, the package  1  can be hermetically sealed in a suitable envelope like container (not shown) to be stored for a later use. 
         [0068]    The central cavity  22  can receive a capsule of a desiccant material to ensure that the any moisture within the surgical mesh  100  is captured. The desiccant capsule is maintained in position by the tabs  23 . The cut off portions  40  provide a significant exposure to the action of the desiccant capsule. 
         [0069]    It can be appreciated that the receiving portion  2  and the covering member  3  are devoid of sharp angles or sharp edges thus limiting the risk of damaging the container. 
         [0070]    When needed on an operating room, the package  1  can be presented to the medical staff. 
         [0071]    One of the lateral portions  30  of the covering member  3  may be lifted and may be folded along the weakened line  25  thereby giving access to the surgical mesh  100 . 
         [0072]      FIGS. 6  depicts another embodiment of the invention. 
         [0073]    In this embodiment of the invention, the receiving member  2  and the covering member  3  are identical. 
         [0074]    A surgical mesh  100  is positioned onto a receiving member  2  such as the receiving member  2  illustrated on  FIG. 2  and a covering member  3 . The covering member  3  is structurally identical to the receiving member  2 . However, the covering member  3  further includes a cavity  22  for a desiccant capsule. 
         [0075]    The package described herein may be made of any material suitable for sterilization such as plastic, foils, combination thereof and laminates thereof and may be formed using any suitable molding process.