Abstract:
A prosthetic repair patch has a sheet and a plurality of sutures integrated there with. The sheet, with first and second sheet surfaces, completely under covers a hernia in the abdominal tissue of a patient with the first sheet surface adjacently abutting a first surface of the tissue that faces away from a person installing the patch. The sutures are connected to the sheet in a spaced apart configuration from one another and each has a longitudinal end thereof that extends from the first sheet surface. Each suture end is adapted to extend through the tissue for locally abutting the first sheet surface to the first tissue surface and to extend from an opposite second surface of the tissue for attachment with another suture end thereat for local fastening of the sheet to the tissue. The present invention also discloses a method of under covering a hernia with the repair patch.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to prosthetic repair patches for repairing undesired apertures, such as hernias, in biological tissue of the abdominal wall of a patient, and is more particularly concerned with a prosthetic repair patch having integrated sutures. 
       BACKGROUND OF THE INVENTION 
       [0002]    It is well known in the art to use prosthetic repair patches to repair, by under covering, undesired apertures, such as hernias, in biological tissue of the abdominal wall, aponeurosis or the like of a patient with prosthetic repair patches. Typically, such patches are made of biologically compatible material and are surgically placed under the hernia and then connected to the abdominal wall surrounding the hernia using sutures. 
         [0003]    An example of such a prosthetic repair patch is described in U.S. Pat. No. 6,120,539, issued to Eldridge et al. The patch described therein comprises a sheet used for, among other things, repair of ventral hernias, in patients by placement of the patch under the hernia with a first sheet surface thereof in adjacent abutment to the surrounding tissue, typically a first tissue surface which faces away from the health professional that is placing the patch in the patient to repair the hernia. The advantages of using such patches, as opposed to other approaches for repairing hernias, are generally well known in medical arts, and include, notably, reduced risk of hernia reoccurrence. Such patches are typically connected to the surrounding tissue, the abdominal wall in the case of ventral hernias, with sutures. Each suture is generally a biologically compatible thread or fiber having generally opposed first and second ends. The suture is typically inserted by the health professional into the surrounding tissue from a second tissue surface, facing towards the health professional and generally opposite the first tissue surface, through the tissue and the first tissue surface and then through the patch. The suture is then drawn across a portion of a second sheet surface, generally opposite the first sheet surface, and then back through the sheet, the tissue, and the second tissue surface. Thus, there is an intermediate portion, intermediate the ends, extending across a portion of the second sheet surface. The suture, and more specifically the ends thereof, may then be pulled towards the health professional to ensure that the first sheet surface is held locally adjacently abutting the first tissue surface with the ends fastened together. This operation is generally repeated for each suture until the sheet is connected around the entirety of its perimeter to the surrounding tissue with the first sheet surface adjacently abutting the first tissue surface and a portion of the sheet completely covering the hernia. This technique is typically referred to as an underlay repair for a hernia, the advantages of which are well known to one skilled in the medical arts. 
         [0004]    Unfortunately, as described above, the use of conventional patches for the underlay hernia repair technique described above obliges the health professional to insert the sutures through the tissue and the sheet of the patch, often with a needle, and then to loop the suture back through the sheet and tissue. As the sheet is placed on the first tissue surface facing away from the health professional, when the suture and needle are inserted through the sheet and tissue, they are often inserted towards subjacent internal organs, which creates a danger that the needle will pierce, and potentially damage, the subjacent internal organs. This may lead to surgical and post-surgical complications, such as, among others, tearing, bleeding (internal hemorrhage) of the internal organs such as intestine or the like and infection thereof (peritonitis, abscess). For example, in the case underlay repair of ventral hernias, the suture and needle are inserted towards the intestine, which poses a risk of damage thereto. Additionally, as the safe passage of the suture through the surrounding tissue and sheet requires careful manipulation of the needle to avoid other portions of non-damaged tissue, the use of conventional patches for the underlay procedure is also time consuming and complex. 
         [0005]    Conventional installation of patches often leads to non-uniform and unequal attachment of the patch to the abdominal wall all around the hernia, which subsequently leads recurrent patch repair on a same patient. 
         [0006]    Accordingly, there is a need for an improved prosthetic replacement patch and method of use thereof that obviate the aforementioned difficulties. 
       SUMMARY OF THE INVENTION 
       [0007]    It is therefore a general object of the present invention to provide an improved prosthetic replacement patch for repairing hernias in biological tissue of the abdominal wall or the like of a patient and a method therefor. 
         [0008]    An advantage of the present invention is that repair of the hernia is simplified and accelerated by using the patch provided by the present invention. 
         [0009]    Another advantage of the present invention is that the risk of piercing or damaging other tissue and subjacent internal organs during connection of the patch provided by the present invention to the tissue surrounding the hernia is reduced. 
         [0010]    A further advantage of the patch provided by the present invention is that the risk of infection, either to the tissue surrounding the hernia or to other subjacent internal tissue, is reduced by use thereof to repair the hernia. 
         [0011]    Still another advantage of the present invention is that the uniform and equal installation and attachment of the patch to the abdominal wall is increased while the risk of recurrence of the hernia is reduced. 
         [0012]    Another advantage of the present invention is that the patch thereby allows for better placement of the patch compared to conventional placement of the patch. 
         [0013]    According to a first aspect of the present invention, there is provided a prosthetic repair patch comprising:
       a sheet comprising biologically compatible material, the sheet having first an second sheet surfaces and being sized and shaped for completely covering an aperture in biological tissue in a body of a patient with the first sheet surface adjacently abutting a first tissue surface of the tissue, the first tissue surface generally facing away from a person installing the patch; and   a plurality of sutures connected to the sheet in a spaced apart configuration from one another and extending from the first sheet surface, each the suture being adapted to extend through the tissue for locally and adjacently abutting the first sheet surface to the first tissue surface to extend from an opposite second surface of the tissue for attachment with another the suture adjacent the second tissue surface to locally fasten the sheet to the tissue.       
 
         [0016]    In a second aspect of the present invention, there is provided a method for covering an aperture in an internal biological tissue extending therearound in a body of a patient with a prosthetic repair patch comprising a sheet of biologically compatible material and sutures connected thereto and extending from a first sheet surface thereof, the method comprising the steps of:
       a) positioning said sheet proximal a first tissue surface of the tissue in the body with said first sheet surface facing the first tissue surface and said sheet extending under the aperture, the first tissue surface generally facing away from a person installing said patch;   b) extending each said suture end through the tissue and out from a second tissue surface of the tissue generally opposite the first tissue surface;   c) pulling each said suture end until said first sheet surface locally and adjacently abuts the first tissue surface while under covering the aperture;   d) attaching each said suture end with another said suture end adjacent the second tissue surface to locally fasten said sheet to the tissue.       
 
         [0021]    Other objects and advantages of the present invention will become apparent from a careful reading of the detailed description provided herein, with appropriate reference to the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    Further aspects and advantages of the present invention will become better understood with reference to the description in association with the following Figures, in which similar references used in different Figures denote similar components, wherein: 
           [0023]      FIG. 1  is a top perspective view of a prosthetic repair patch in accordance with an embodiment of the present invention, with integrated sutures; 
           [0024]      FIG. 2  is top perspective view of biological abdominal tissue having a hernia (aperture) therein and surrounded thereby, with the patch shown in  FIG. 1  under covering, and thereby repairing, the aperture; 
           [0025]      FIG. 3  is a side sectional view of the abdominal tissue and patch shown in  FIG. 2 , taken along line  3 - 3  of  FIG. 2 ; 
           [0026]      FIG. 4   a  is a perspective view of the patch shown in  FIG. 1  with the sutures in a first suture configuration laid on a first sheet surface of the patch; 
           [0027]      FIG. 4   b  is a view similar to  FIG. 4   a  showing another embodiment of the present invention with the sutures arranged in groups; and 
           [0028]      FIG. 5  is a perspective view of the patch shown in  FIG. 4   d  in a rolled up configuration. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0029]    With reference to the annexed drawings the preferred embodiments of the present invention will be herein described for indicative purpose and by no means as of limitation. 
         [0030]    Reference is now made to  FIGS. 1 and 2 , which show a prosthetic replacement patch, shown generally as  10 , in accordance with an embodiment of the present invention for repairing an aperture  20  or hernia in surrounding biological tissue  22  of the abdominal wall of a patient. For the purposes of this description, it should be noted that the term aperture  20  denotes any undesired aperture  20  in biological tissue  22  of a patient, including hernias, tears, punctures, and the like. However, the patch  10  described herein is ideally suited for repair of hernias, and ventral hernias in a particular, using an underlay repair surgical technique. It should also be noted that the term repair, with regard to apertures  20  in the tissue  22 , generally denotes, for the purposes of this description, the complete under covering of an aperture  20  with the patch  10  and the connecting of the patch  10  to surrounding tissue  22  surrounding the aperture  20 , such that the aperture  20  is completely covered, i.e. closed. However, the patch  10  described herein is particularly suited for use in underlay hernia repair procedures, in which the patch  10  is placed underneath the surrounding abdominal tissue  22  surrounding the aperture  20 , i.e. facing a first tissue surface  24  facing away from the health professional placing the patch in the patient, with the patch completely under covering the aperture  20  and sutured to the surrounding tissue  22  on a second tissue surface  26 , generally opposite the first tissue surface  24 . 
         [0031]    The patch  10  has a sheet  12 , possibly having multiple layers, and which has a first sheet surface  14  and a second sheet surface  16  comprised of biologically compatible material, suitable for placement within a patient. Such biologically compatible materials typically consist of, for example, polyester, polyglycolic acid, polypropylene, polytetrafluoroethylene, and a combination of polytetrafluoroethylene and polypropylene. However, any biologically compatible material typically suitable for long term or permanent placement within a patient, or eventually resorptive (absorbable), and which is suitable for under covering the aperture  20  in the surrounding biological abdominal tissue  22  may be deployed. The sheet  12  is sized and shaped for completely covering the aperture  20  in the surrounding biological tissue  22  with the first sheet surface  14  adjacently and locally abutting the first tissue surface  24  for closing off, i.e. covering, and repairing the aperture  20 . 
         [0032]    Referring now to  FIGS. 1 ,  2 , and  3 , the patch  10  also has a plurality of sutures  18 , connected to the sheet  12  in a spaced apart configuration from each other, preferably around the entire perimeter  28  of the sheet  12  and which have at least one, preferably respective both longitudinal end  34   a ,  34   b  extending from the first sheet surface  14 . The sutures  18 , integral to the patch  10 , are used to connect the sheet  12  to the tissue  22  to at least partially secure the sheet  12  thereto with the first sheet surface  14  adjacently abutting the first tissue surface  24  for under covering the aperture  20 . More specifically, each end  34   a ,  34   b  of the sutures  18  are adapted for extension through the tissue  22 , from the first tissue surface  24  to the second tissue surface  26 , for locally and adjacently abutting the first sheet surface  14  to the first tissue surface  24  with the sutures ends  34   a ,  34   b  extending outwardly from the second tissue surface  26  for attachment of each suture end  34   a  to another suture end  34   b  adjacent the second tissue surface  26 , typically of the same suture  18 . Accordingly, the sutures locally fasten the sheet  12  to the tissue  22  with the first sheet surface  14  adjacently abutting the first tissue surface  24  for completely under covering, and thereby repairing, the aperture  20 . The sutures  18  are also made from biologically compatible materials, such as those mentioned for the sheet  12 , and are preferably monofilament sutures. 
         [0033]    Having described the general characteristics of the patch  10 , the deployment thereof for use in an underlay repair procedure for an aperture  20 , such as a ventral hernia, is now described with reference to  FIGS. 2 and 3 . Initially, the patch  10  is positioned with the sheet  12 , and preferably the first sheet surface  24 , proximal the first tissue surface  24  and extending under and toward the aperture  20 . The sutures  18  (end  34   a ,  34   b  pairs as shown) are then extended, i.e. drawn, through the tissue  22 , from the first tissue surface  24  therethrough and out of the second tissue surface  26 . The drawing of the suture  18  through the tissue  22  may be effected, for example, by inserting a conventional suture passer (or through wire instrument)—not shown—through the tissue  22  from the second tissue surface  26  through the first tissue surface  24 , engaging the suture  18  therewith, and drawing the suture  18  therewith through the tissue  22  from the first tissue surface  24  toward and out of the second tissue surface  26 . Each suture end  34   a ,  34   b  is then pulled until the first sheet surface  14  locally and adjacently abuts the first tissue surface  24  while covering the aperture  20 . Suture ends  34   a ,  34   b  (preferably of a same suture  18 ) are then attached to one another adjacent the second tissue surface  26  to locally fasten the sheet  12  to the tissue  22  with the sheet  12 , and notably the first sheet surface  14 , under covering the aperture  20 . 
         [0034]    Advantageously, since the sutures  18  are already connected to the sheet  12 , there is no need, unlike with conventional patches, to use a needle or other surgical tool to thread the suture  18  from the first sheet surface  14  through the sheet  12 , and possibly out through the second sheet surface  16 , and then back through the sheet  12  out of the first sheet surface  14  to connect the suture to the sheet  12 . Accordingly, the surgical procedure of repairing the aperture  20  with the patch  10  of the present invention is facilitated and the amount of time required to perform the procedure, compared to conventional patches, is reduced. Further, the risk of damaging other tissue or internal organs in proximity to the surrounding tissue  22  by inserting a needle or other instrument through the patch, as required with conventional patches, is eliminated. The elimination of this risk also reduces the risk of infection and of complications. In addition, as the sutures  18  are already attached to the patch  10  in a spaced apart relationship around the perimeter  28  (at between about 0.5 cm (0.2 inch) and about 2.5 cm (1 inch), and preferably about 1 cm (0.4 inch) therefrom), the risk of irregular stitching, non-uniform placement or attachment of the sutures  18  to the patch  10  and tissue  22 , which may be encountered with conventional patches, is reduced and proper placement of the patch  10  relative the tissue  22  and aperture  20  is facilitated. 
         [0035]    Referring to  FIGS. 1 and 3 , for the embodiment shown, both suture ends  34   a ,  34   b  of a same suture  18  are spaced apart relative one another at a distance d 1  varying between about 5 mm (0.2 inch) and about 10 mm (0.4 inch). Similarly, adjacent suture ends  34   a ,  34   b  from adjacent sutures  18  are spaced apart relative one another at a distance d 2  varying between about 0 mm (0 inch) and about 10 mm (0.4 inch), and preferably at about 7-8 mm (0.3 inch). These distances d 1 , and especially d 2 , are intended to ensure the uniformity of the patch attachment and that each suture end  34   a  can be readily engaged with a suture passer and pulled through the tissue  22  for attachment to another, preferably adjacent, suture end  34   b  for securely connecting the sheet  12  to the tissue  22  with the sutures  18  relatively evenly distributed therearound. More specifically, and as shown in  FIGS. 1 and 3 , the sutures  18  typically form pairs, shown generally as  30 , of adjacent suture ends  34   a ,  34   b . Each pair  30  of adjacent suture ends  34   a ,  34   b  consists of a thread  32  of biologically compatible material, typically non-absorbable. Each thread  32  is threaded through the sheet  12  with an intermediate portion  36  of the thread  32  extending across a portion of the second sheet surface  16  and the first and second ends  34   a ,  34   b  extending out from the first sheet surface  14  and respectively forming the pair from a suture  18 . However, one skilled in the art will appreciate that sutures  18  need not be connected to the sheet  12  in this fashion. In fact, each suture  18  could, if desired, be a single thread securely connected to, or having the intermediate portion  36  connected to the sheet  12  to one of the sheet surfaces  14 ,  16 , or therebetween. 
         [0036]    While the distances for the spacing of the sutures  18  described herein are well adapted for use of the patch  10  to repair apertures  20  such as ventral hernias, the spacing may be adapted, i.e. modified, in function of the size of the sheet  12  as well as the size of the aperture  20  to be repaired. For example, larger apertures may require larger sheets and greater, or less, spacing between sutures  18 . 
         [0037]    Further, sutures  18  could also be arranged in spaced apart groups  38 , as shown in  FIGS. 4   b  and  5 , of at least one suture  18 , each end  34  of each suture  18  of each group  38   a ,  38   b ,  38   c ,  38   d  being configured for attachment to the corresponding suture end  34   b  of a same suture  18  of the same group  38   a ,  38   b ,  38   c ,  38   d . Each group  38   a  or  38   b  of suture  18  would, preferably, extend from the first sheet surface  14  at a position thereon substantially opposite an opposing group  38   c  or  38   d , with the sheet  12  being connected to the tissue  22  via alternative means, such as, for example, stapling of or application of a biologically compatible adhesive to the sheet  12  at least in spaces extending between the groups. The use of multiple groups is especially useful the patch installation is made via laparoscopic treatment. To ensure proper orientation of the patch  10  relative to the aperture  20 , the different groups  38  of sutures  18 , typically opposite groups  38   a ,  38   c  and  38   b ,  38   d  on symmetrical patches, are visually identified using visual identifiers  39  such as different suture colors, suitable printed markings on the patch adjacent the groups (as dots, bars, letters T, B, L and R for top, bottom, left and right or N, S, E and W for north, south, east and west) and the like, as shown in  FIG. 4   b.    
         [0038]    Reference is now made to  FIGS. 4   b  and  5 . Optionally, the patch  10  may be manufactured, packaged, or otherwise initially configured in a compactly rolled first sheet configuration, shown generally as  40  in  FIG. 4   b , in which the sheet  12  is compactly rolled. The compact first sheet configuration  40  facilitates insertion of the sheet  12  into the body of the patient and placement of the sheet  12  in proximity to the aperture  20  and tissue  22 . The sheet  12  may then be unrolled into the second sheet configuration, shown generally as  42  in  FIG. 5 , for connection to the tissue  22  to under cover the aperture  20 . The compact first configuration  40  is particularly useful for reducing the size of incisions required for inserting the patch  10  into the body of the patient, especially when the surgical procedure for repairing the aperture  20  with the patch  10  is performed laparoscopically. 
         [0039]    Referring now to  FIG. 2 , optionally, the sutures  18  may be initially placed in a first suture configuration, shown generally as  44  in  FIGS. 2 ,  4   a  and  4   b , and in which the suture ends  34   a ,  34   b  are laid securely, ideally partially folded or rolled, and twisted in corresponding pairs  30  (for improved identification thereof since the suture ends  43   a ,  34   b  could easily be about 15 to 20 cm (6-8 inches) long) across the first sheet surface  14 . The suture ends  34   a ,  34   b  may then be extended into a second configuration, shown as  46  in  FIGS. 1 and 2 , for connection to the tissue  12 . The first suture configuration  42 , which may be combined with the first sheet configuration  40 , advantageously facilitates placement of the patch  10  with the sutures  18  readily engageable in a known configuration, i.e. first suture configuration  44 , thus facilitating engagement thereof with a medical instrument such as a suture passer for extending the suture ends  34   a ,  34   b  into the extended second suture configuration  46  for connection to the tissue  22 . Typically, as partially illustrated in  FIG. 2 , the health professional, for the installation of the patch  10  once in proper position relative to the aperture  20 , untwist a first suture pair  30  and extend the to suture ends  34   a ,  34   b  through the tissue  22  before attachment to one another with the unused portion thereof being cut away and discarded; and typically each suture pair  30  being connected to the tissue one after another (again color coding or the like visual identifiers  39  help the installation process). As with the first sheet configuration  40 , the first suture configuration  44  is particularly useful when the surgical procedure for repairing the aperture  20  with the patch  10  patch is performed laparoscopically. 
         [0040]    Although the present patch  10  has been described with a certain degree of particularity, it is to be understood that the disclosure has been made by way of example only and that the present invention is not limited to the features of the embodiments described and illustrated herein, but includes all variations and modifications within the scope and spirit of the invention as hereinafter claimed.