Patent Publication Number: US-2021169628-A1

Title: Device especially useful for hernia repair surgeries and methods thereof

Description:
RELATED CASE INFORMATION 
     This application is a continuation of U.S. patent application Ser. No. 13/770,637, which is a continuation of U.S. patent application Ser. No. 12/516,373, which is a National Phase Application of PCT Application No. PCT/IL2007/001463 having an International Filing Date of Nov. 27, 2007, which claims the benefit of U.S Provisional Patent Application No. 60/861,095, filed on Nov. 27, 2006. 
    
    
     FILED OF THE INVENTION 
     The present invention generally related to a device especially useful in hernia repair and a method of using the same. 
     BACKGROUND OF THE INVENTION 
     This invention generally relates to a device, especially useful for hernia repair surgery. 
     Hernia, denoted hereinafter for umbilical hernia, ventral hernia, postoperative ventral hernia epigastric, hernia, spiegelian hernia inguinal hernia, etc. is a common medical condition in which an organ protrudes through an opening in its surrounding wails (especially in the abdominal region). Hernia is sometimes treated in a tension free repair, such as implementation of meshes, patches etc. This procedure requires the insertion of a wide mesh via a relatively small aperture such that the mesh is located in a posterior layer parallel to the abdominal wall. The insertion of the mesh implants to the abdominal wall by means of laparoscopic technique or similar medical procedures requires more than one aperture and thus the abdominal wall is punctured several times. Those procedures require anesthesia and usually demand a relatively long healing time. 
     One of the major problems of the above procedure is the unrolling or spreading and the positioning or deploying of the mesh inside the abdominal or the pre-peritoneal cavity. The step of unrolling the mesh, directing the right side of the mesh, positioning and fixating the mesh and positioning it in the right place usually adds significantly to the time required for carrying out the procedure. Moreover, inserting the mesh/patch into the body without a trocar may expose the mesh/patch to infections. 
     Some techniques suggested in the literature disclose mesh-like for treating hernia. Those techniques fail to guarantee even, complete and smooth deployment of the mesh, without formation of wrinkles, and cannot ensure full anchoring of the implant to the abdominal wall. 
     U.S. Pat. No. 5,824,082 (&#39;082) relates to a prosthetic hernia repair patch that can be roiled into a tube for laparoscopic delivery through a trocar and which deploys to a generally planar form when ejected from the trocar into the abdominal cavity. The deployment of the prosthetic is done by embedding a wire frame made of shape memory alloys into the prosthetic. When the prosthetic is inserted into the body it is heated thus, activated—i.e. it springs into its functional, predetermined configuration and deploys the patch. However, embedding a wire frame in a prosthetic is complicated. 
     Thus, there is still a long felt need for a device that is simple, will shorten the time required for the spreading and the positioning of the mesh inside the body and will be inserted via a single small-bore opening. 
     SUMMARY OF THE INVENTION 
     It is one object of the invention to disclose an inflatable contour-balloon useful in minimal invasive and/or open surgery; wherein at least a portion of said inflatable contour-balloon is positioned in the contour of a mesh and/or a patch and/or a net; further wherein said inflatable contour-balloon is adapted to spread and/or deploy said mesh and/or said patch and/or said net in the abdominal cavity and/or pre-peritoneal and/or space and/or hollow body organs and/or natural and/or artificial orifices and/or spaces and/or post operative spaces. 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said inflatable contour-balloon is especially adapted for use in hernia repair surgery. 
     it is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said inflatable contour-balloon additionally comprising means adapted to adjust the center of said inflatable contour-balloon to the center of said hernia. 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said inflatable contour-balloon additionally comprising means adapted to ensure the right side of said mesh or said patch or said net is directed to said abdominal cavity and/or said pre-peritoneal and/or said space and/or said hollow body organs and/or said natural and/or said artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the inflatable contour balloon as define above, wherein said inflatable contour-balloon is provided with means enabling coupling of inflating means to said inflatable contour-balloon. 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said means is selected from a group comprising at least one radial tube, non radial tubes. 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said inflating means is selected from a group consisting manually inflating pump, motorized inflating pump, 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said inflatable contour-balloon is provided with means enabling threading of said mesh and/or said patch to said inflatable contour-balloon. 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said means is selected from a group comprising at least one slit. 
     it is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said inflatable contour-balloon is glued to said mesh and/or said patch and/or said net 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said inflatable contour-balloon is provided with means enabling sewing of said inflatable contour-balloon to said mesh and/or patch and/or said net. 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said inflatable contour-balloon is made of a group comprising biocompatible materials, self-dissolving materials and shape memory materials. 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein the shape of said inflatable contour-balloon is selected from a group comprising a polygonal shape, a curved shape, a symmetrical, a non-symmetrical shape, a linear shape, continues, non-continues, a concave shape, a irregular shape, a square-like shape, a rectangular shape, an oval shape, a U-like shape, a grid-like shape, a flat structure, a 3D structure and a rake-like shape or any combination thereof. 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein said inflatable contour-balloon comprises at least two independent parts. 
     It is another object of the invention to disclose the inflatable contour-balloon as define above, wherein the configuration is as described in any of  FIG. 13  to  FIG. 17 . 
     It is another object of the invention to disclose a method for spreading and/or deploying a mesh and/or a patch, useful in minimal invasive and/or open surgery. The method comprises step selected inter alia from (a) obtaining an inflatable contour-balloon as define above; (b) attaching said inflatable contour-balloon to said mesh and/or to said patch; (c) coupling said inflating means to said inflatable contour-balloon; (d) adjusting said inflatable contour-balloon; (e) inserting said adjusted inflatable contour-balloon into abdominal cavity and/or pre-peritoneal and/or hollow body organs and/or natural and/or artificial orifices and/or spaces and/or post operative spaces; and, (f) inflating at least a portion of said inflatable contour-balloon via said inflating means; thereby spreading and/or deploying said mesh and/or said patch in said abdominal cavity and/or said pre-peritoneal and/or said hollow body organs and/or said natural and/or said artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of uncoupling said inflating means from said inflatable contour-balloon. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of extracting said inflatable contour-balloon from said abdominal cavity and/or said pre-peritoneal and/or said hollow body organs and/or said natural and/or said artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of deflating said inflatable contour-balloon. 
     It is another object of the invention to disclose the method as define above, especially in hernia repair surgery. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of fitting the center of said inflatable contour-balloon. to the center of said hernia. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of ensuring the right side of said mesh or said patch or said net is directed to said abdominal cavity and/or said pre-peritoneal and/or said space and/or said hollow body organs and/or said natural and/or said artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of threading said mesh or/and said patch or/and said net to said inflatable contour-balloon. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of gluing said mesh or/and said patch or/and said net to said inflatable contour-balloon. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of selecting said inflatable contour-balloon from a group comprising biocompatible materials, self-dissolving materials, shape memory materials. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of selecting the shape of said inflatable contour-balloon from a group comprising a polygonal shape, a curved shape, a symmetrical, a non-symmetrical shape, a linear shape, continues, non-continues, a concave shape, a irregular shape, a square-like shape, a rectangular shape, an oval shape, a U-like shape, a grid-like shape, a flat structure, a 3D structure and a rake-like shape or any combination thereof. 
     It is another object of the invention to disclose the method as define above, additionally comprising the step of continuing inflating said inflatable contour-balloon according to a predetermined medical need. 
     It is another object of the invention to disclose an elongate open-bored applicator (EOBP) useful in minimal invasive surgery; said EOBP having a distal portion that is insertable into the abdominal cavity and/or pre-peritoneal and/or space and/or hollow body organs and/or natural and/or artificial orifices and/or spaces and/or post operative spaces; and a proximal portion that remains outside said body. The EOBP comprising:
         a. at least one inflatable contour-balloon as defined above;   b. at least one inflatable dissection balloon; said inflatable contour-balloon and said inflatable dissection balloon are adjustable and located at said distal portion; and,   c. at least one actuating means located at said proximal portion; said actuating means is in communication with said inflatable contour-balloon and said inflatable dissection balloon; said actuating means is adapted to provide said inflatable contour-balloon and said inflatable dissection balloon with independent activation and/or de-activation;       

     wherein said device is adapted to spread and/or deploy a mesh and/or a patch and/or a net in said abdominal cavity and/or in said pre-peritoneal and/or in said space and/or hollow body organs and/or in said natural and/or artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said actuating means additionally comprises inflating means used to inflate said at least one inflatable dissection balloon and said at least one inflatable contour-balloon. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said EOBP is especially adapted for use in hernia repair surgery. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said EOBP additionally comprising means adapted to adjust the center of said inflatable contour-balloon to the center of said hernia. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said EOBP additionally comprising means adapted to ensure the right side of said mesh or said patch or said net is directed to said abdominal cavity and/or said pre-peritoneal and/or said space and/or said hollow body organs and/or said natural and/or said artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said EOBP is provided with means enabling coupling of inflating means to said inflatable contour-balloon; and the coupling of inflating means to said inflatable dissection balloon. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said means is selected from a group comprising at least one radial tube, non radial tubes. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said inflating means is selected from a group comprising manually inflating pump, motorized inflating pump. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said EOBP is provided with means enabling threading of said mesh and/or said patch to said inflatable contour-balloon. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said means is selected from a group comprising at least one slit. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said inflatable contour-balloon is glued to the edges of said mesh and/or said patch and/or said net. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said EOBP is provided with means enabling sewing of said inflatable contour-balloon to said mesh and/or patch and/or said net. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said inflatable contour-balloon and/or said dissection balloon is made of a group comprising biocompatible materials, self-dissolving materials and shape memory materials. 
     It is another object of the invention to disclose the EOBP as defined above, wherein the shape of said inflatable contour-balloon and/or said inflatable dissection balloon is selected from a group comprising a polygonal shape, a curved shape, a symmetrical, a non-symmetrical shape, a linear shape, continues, non-continues, a concave shape, a irregular shape, a square-like shape, a rectangular shape, an oval shape, a U-like shape, a grid-like shape, a flat structure, a 3D structure and a rake-like shape or any combination thereof. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said inflatable contour-balloon comprises at least two independent parts. 
     It is another object of the invention to disclose the EOBP as defined above, configured as described in any of  FIG. 13  to  FIG. 17 .. 
     It is another object of the invention to disclose the EOBP as defined above, configured as described in any of  FIG. 10 a    to  FIG. 10   g.    
     It is another object of the invention to disclose a method for spreading and/or deploying a mesh and/or a patch, useful in minimal invasive and/or open surgery. The step comprises step selected inter alia from (a) obtaining an EOBP as defined above; (b) attaching said inflatable contour-balloon to said mesh and/or to said patch; (c) coupling said inflating means to said inflatable contour-balloon and said inflatable dissection balloon; (d) adjusting said inflatable contour-balloon and said inflatable dissection balloon; (e) introducing said device into abdominal cavity and/or pre-peritoneal and/or hollow body organs and/or natural and/or artificial orifices and/or spaces and/or post operative spaces; and, (f) inflating at least a portion of said inflatable contour-balloon via said inflating means; thereby spreading and/or deploying said mesh and/or said patch in said abdominal cavity and/or said pre-peritoneal and/or said hollow body organs and/or said natural and/or said artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of inflating at least a portion of said inflatable dissection balloon via said inflating means. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of uncoupling said inflating means from said inflatable contour-balloon. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of uncoupling said inflating means from said inflatable dissection balloon. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of deflating said inflatable contour-balloon. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of deflating said inflatable dissection balloon. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of extracting said inflatable contour-balloon from said abdominal cavity and/or said pre-peritoneal and/or said hollow body organs and/or said natural and/or said artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of extracting said inflatable dissection balloon from said abdominal cavity and/or said pre-peritoneal and/or said hollow body organs and/or said natural and/or said artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the method as defined above, especially in hernia repair surgery. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of fitting the center of said inflatable contour-balloon to the center of said hernia. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of ensuring the right side of said mesh or said patch or said net is directed to said abdominal cavity and/or said pre-peritoneal and/or said space and/or said hollow body organs and/or said natural and/or said artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of threading said mesh or/and said patch or/and said net to said inflatable contour-balloon. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of gluing said mesh or/and said patch or/and said net to said inflatable contour-balloon. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of selecting said inflatable contour-balloon and/or said inflatable dissection balloon from a group comprising biocompatible materials, self-dissolving materials, shape memory materials. 
     It is another object of the invention to disclose the method as defined above, additionally comprising the step of selecting the shape of said inflatable contour-balloon and/or said inflatable dissection balloon from a group comprising a polygonal shape, a curved shape, a symmetrical, a non-symmetrical shape, a linear shape, continues, non-continues, a concave shape, a irregular shape, a square-like shape, a rectangular shape, an oval shape, a U-like shape, a grid-like shape, a flat structure, a 3D structure and a rake-like shape or any combination thereof. 
     It is another object of the invention to disclose the EOBP as defined above, wherein said actuating means are adapted to extract said inflatable contour-balloon and/or said inflatable dissection balloon from said abdominal cavity and/or in said pre-peritoneal and/or in said space and/or hollow body organs and/or in said natural and/or artificial orifices and/or said spaces and/or said post operative spaces. 
     It is another object of the invention to disclose the EOBP as defined above, additionally comprising means adapted to anchor said EOBP in said abdominal cavity and/or in said pre-peritoneal and/or in said space and/or hollow body organs and/or in said natural and/or artificial orifices and/or said spaces and/or said post operative spaces. 
     It is still an object of the invention to disclose the method as defined above, additionally comprising the step of continuing inflating said inflatable dissection balloon according to a predetermined medical need. 
     It is lastly an object of the invention to disclose the method as defined above, additionally comprising the step of continuing inflating said inflatable contour-balloon according to a predetermined medical need. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       In order to understand the invention and to see how it may be implemented in practice, a plurality of preferred embodiments will now he described, by way of non-limiting example only, with reference to the accompanying drawings, in which 
         FIG. 1  schematically present general view of the of the elongate open-bored applicator. 
         FIGS. 1 a -1 d    schematically display wings-like means adapted to anchor the elongate open-bored applicator  100  within the tissue and to thrust the tissue. 
         FIG. 2  schematically display the elongate open-bored applicator once the posterior portion is inside the body. 
         FIGS. 2 a -2 d    schematically present general view of the applicator, the inflatable dissection balloon, the inflatable contour-balloon and the mesh. 
         FIG. 3  schematically presents cut view of the in the middle of the applicator.  FIG. 4 a    and  FIG. 4 b    displaying an applicator according to another embodiment of the present invention. 
         FIG. 5  schematically presents the applicator according to another embodiment of present invention. 
         FIG. 6 a   , presents a cut view in the middle of the applicator  100  according to the embodiment described in  FIG. 5 . 
         FIG. 6 b    displays the applicator according to another embodiment of the present invention. 
         FIGS. 7 a  to 7 e    schematically present the mesh implanting process according to one embodiment of the present invention. 
         FIGS. 8 a  to 8 e    schematically present the mesh implanting process according to another embodiment of the present invention. 
         FIGS. 9 a  to 9 g    present possible solutions or means for centering the mesh with respect to the inflatable dissection balloon. 
         FIGS. 10 a -10 g    present possible designs of the inflatable dissection balloon and possible coupling options between said inflatable balloon and the mesh. 
         FIGS. 11 a -11 d    present possible valve designs for sealing the airway of the inflatable contour-balloon. 
         FIG. 12  presents a possible design a handle which is also used as an air pump. 
         FIGS. 13 a -13 o    schematically display a different design of the inflatable contour-balloon; furthermore  FIGS. 13 a -13 o    display different options for connecting the mesh/net/patch to the balloons. 
         FIGS. 14, 15 and 16  schematically display different rectangle shapes of the inflatable contour-balloon and the mesh. 
         FIG. 17  schematically represents the inflatable contour-balloon and the mesh according to another embodiment of the present invention. 
         FIG. 18  displays an option of attaching the mesh to the inflatable contour-balloon. 
         FIG. 19  displays the inflatable contour-balloon with the mesh threaded inside the slits. 
         FIGS. 20 a  and 20 b    display a more detail look of the same. 
         FIGS. 20 c -20 e    display a different way to couple the inflatable contour-balloon and the mesh. 
         FIG. 20 f    displays another design of the inflatable contour-balloon and the mesh. 
         FIGS. 20 g  and 20 h    display another option to couple the inflatable contour-balloon and the mesh. 
         FIGS. 20 i -20 j    display different designs of the inflatable contour-balloon. 
     
    
    
     DETAIL DESCRIPTION OF THE INVENTION 
     The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of the carrying out this invention. Various modifications, however, is adapted to remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide an inflatable contour-balloon useful in minimal invasive and/or open surgery. The inflatable contour-balloon positioned in the contour of a mesh and/or a patch and/or a net. The inflatable contour-balloon is adapted to spread and/or deploy a mesh and/or a patch and/or a net in the abdominal cavity and/or pre-peritoneal and/or space and/or hollow body organs and/or natural and/or artificial orifices and/or spaces and/or post operative spaces. 
     The present invention also provides a method for spreading and/or deploying a mesh and/or a patch, useful in minimal invasive and/or open surgery. The method comprises step selected inter alfa from (a) obtaining an inflatable contour-balloon; (b) attaching the inflatable contour-balloon to the mesh and/or to the patch; (c) coupling the inflating means to the inflatable contour-balloon; (d) adjusting the inflatable contour-balloon; (e) inserting the adjusted inflatable contour-balloon into abdominal cavity and/or pre-peritoneal and/or hollow body organs and/or natural and/or artificial orifices and/or spaces and/or post operative spaces; and (f) inflating at least a portion of the inflatable contour-balloon via the inflating pump; thereby spreading and/or deploying said mesh and/or the patch in the abdominal cavity and/or the pre-peritoneal and/or the hollow body organs and/or the natural and/or the artificial orifices and/or the spaces and/or the post operative spaces. 
     The present invention also provides a device adapted to spread and/or deploy a mesh and/or a patch, useful in minimal invasive and/or open surgery. The device comprising: (a) at least one inflatable contour-balloon; (b) one inflatable dissection balloon; (c) at least one actuating means. The device is adapted to spread and/or deploy a mesh and/or a patch and/or a net in the abdominal cavity and/or pre-peritoneal and/or space and/or hollow body organs and/or natural and/or artificial orifices and/or spaces and/or post operative spaces. 
     The present invention also provides a method for spreading and/or deploying a mesh and/or a patch, useful in minimal invasive and/or open surgery. The method comprises step selected inter alia from (a) obtaining a device; (b) attaching the inflatable contour-balloon to the mesh and/or to the patch; (c) coupling the inflating means to the inflatable contour-balloon and the inflatable dissection balloon; (d) adjusting the inflatable contour-balloon and the inflatable dissection balloon; (e) introducing the device into abdominal cavity and/or pre-peritoneal and/or hollow body organs and/or natural and/or artificial orifices and/or spaces and/or post operative spaces; (f) inflating at least a portion of the inflatable dissection balloon via the inflating means; and, (g) at least a portion of inflating the inflatable contour-balloon via the inflating means; thereby spreading and/or deploying the mesh and/or the patch in the abdominal cavity and/or the pre-peritoneal and/or the hollow body organs and/or the natural and/or the artificial orifices and/or the spaces and/or the post operative spaces. 
     The methods can comprise steps selected inter alia from extracting the inflatable contour-balloon and/or the inflatable dissection balloon from the abdominal cavity and/or the pre peritoneal and/or the hollow body organs and/or the natural and/or the artificial orifices and/or the spaces and/or the post operative spaces; continuing inflating the inflatable contour-balloon and/or the inflatable dissection balloon according to a predetermined medical need; deflating the inflatable contour-balloon and/or the inflatable dissection balloon. 
     The term “balloon” refers hereinafter to any flexible bag which can inflates or expands. The balloon can be made from materials such as rubber, latex, silicone, polyurethane, chloroprene or a nylon fabric or any thermoelastomeric materials. The balloon can be made of biocompatible materials, self-dissolving materials or shape memory materials. 
     The term “Hernia” refers hereinafter for umbilical hernia, hiatal hernia, ventral hernia, postoperative hernia, epigastric hernia, spiegelian hernia, inguinal hernia and femoral hernia, generally any abdominal wan related hernia. 
     The term “minimally invasive surgery” refers hereinafter to a procedure that is carried out by entering the body through the skin or through a body cavity or anatomical opening, but with the smallest damage possible. 
     The term “Biocompatible materials” refers hereinafter to materials that have the ability to perform with an appropriate host response in a specific application. Biocompatible materials have the quality of not having toxic or injurious effects on biological systems. 
     The term “self-dissolving materials” refers hereinafter to materials that are degraded by the body&#39;s enzymatic and/or hydrolytic pathways through a reaction against “foreign” material. Some urologists may prefer self-dissolving materials in catheter simply because then they don&#39;t have to go necessarily through the procedure of removing them afterwards. Examples of self-dissolving polymers are Polydioxanone (PDO), Polycaprolactone (PCL), Polylactic acid (PLA), Polyglycolic acid (PGA), Adipic acid, PEG and glutamic acid. 
     The term “shape memory materials” refers hereinafter to materials which can “remember” there original geometry. After a sample of shape memory materials has been deformed from its original geometry, it regains its original geometry by itself during heating (one-way effect) or, at higher ambient temperatures, simply during unloading (pseudo-elasticity or superelasticity). The thermally induced shape-memory effect has been described for different material classes: polymers, such as polyurethanes, poly(styrene-block-butadiene), Polydioxanone and polynorbornene, metallic alloys, such as copper-zine-aluminium-nickel, copper-aluminium-nickel, and nickel-titanium (NiTi) alloys. 
     The term “adjusting” or “adjustable” refers hereinafter to rolling, bending, twisting, folding and winding. 
     The term “activation” refers hereinafter to the act of inflating a balloon. 
     The term “de-activation” refers hereinafter to the act of deflating the balloon (i.e. extracting the air out of the balloon). 
     The term “contour” refers hereinafter to any section (and not only to the outer edge) of the mesh and/or patch and/or net. 
     Reference is now  FIGS. 1-2   d , which schematically present a general view of the elongate open-bored applicator  100  according to the present invention. The elongate open-bored applicator  100  has an anterior portion  11  terminated outside the body and a posterior portion  12  terminated with an orifice  13  insertable into the abdominal cavity abdominal cavity and/or pre-peritoneal and/or space and/or hollow body organs and/or natural and/or artificial orifices and/or spaces and/or post operative spaces. The elongate open-bored applicator  100  comprises at least one inflatable contour-balloon  30 , which is attached to the contours of mesh  20  (the different ways of attaching the inflatable contour balloon  30  to mesh  20  will be discussed later on in the detail description). The elongate open-bored applicator  100  may additionally comprises a second inflatable balloon (refers herein after as inflatable dissection balloon)  10 . The mesh and the inflatable contour-balloon are adjusted to lit inside the applicator  100 . Mesh  20  is adapted to deploy when injected outside the applicator inside the body cavity. The elongate open-bored applicator  100  additionally comprises actuating means  14  adapted to push mesh  20  throughout the applicator via said posterior orifice  13 . The actuating means  14  can comprises a maneuverable pistol and/or handles operating the same (denotes as  14  in  FIG. 1 ) or inflating pumps for inflating the inflatable dissection balloon  10  and the inflatable contour-balloon  30  (denotes as  14  in  FIG. 2 ). 
     Reference is now made to figures la-lb, which schematically display wings-like means  77  adapted to anchor the elongate open-bored applicator  100  within the tissue and to thrust the tissue. The wings-like means  77  are positioned in the posterior portion  12 .  FIG. 1 a    represent the wings-like means  77  in a semi open configuration and  FIG. 1 b    represents the wings-like means  77  in a fully open configuration. Activation means  78  are also provided for activating (i.e. opening and closing) the wings-like means  77 . The activation or de-activation of the wings-like means  77  by the activation means  78  can be performed by sliding the activation means  78  towards and away from the posterior portion  12 . 
     The wings-like means  77  can have the configuration as shown in  FIGS. 1 c -1 d   . In those figures the wings-like means  77  are fixed in their positions. 
     Reference is now made to  FIG. 2  which schematically display the elongate open-bored applicator  100  once the posterior portion  12  is inside the body. As can be seen from  FIG. 2 , both the inflatable dissection balloon  10  and the inflatable contour-balloon  30  are inflated so as mesh  20  is in parallel to the wall of the abdominal cavity. 
     The modus in which both the balloon are inflated can include different timing. For example, the inflatable contour-balloon  30  is inflated to about 50% of its volume, then the inflatable dissection balloon  10  is inflated to about 70% of its volume, and then the inflation of the inflatable contour-balloon  30  is completed. 
     The actuating means  14  are represented in  FIG. 2  as two pumps  14  used for inflating balloons  10  and  30 . It should be pointed out that the present invention is not limited to the use of two pumps. One pump can be used to inflate both balloons  10  and  20  (as seen in  FIG. 2 a   ). 
     Reference is now made to  FIGS. 2 a  and 2 b    schematically present general view of the applicator, the inflatable contour-balloon  30  and mesh  20 . According to  FIG. 2 a    the applicator  100  comprises only the inflatable contour-balloon  30 .  FIG. 2 b    is an enclose view of the inflatable contour-balloon  30  and mesh  20 . 
     Reference is now made to  FIGS. 2 c  and 2 d    schematically present general view of the applicator, the inflatable dissection balloon  10 , the inflatable contour-balloon  30  and mesh  20 . As can be seen in  FIG. 2 c   , the applicator  100  comprises the inflatable contour-balloon  30  and inflatable dissection balloon  10 .  FIG. 2 d    is an enclose view of the inflatable contour-balloon  30 , the inflatable dissection balloon  10  and mesh  20 . 
     Those figures ( FIGS. 2 a -2 d   ) also display the actuating means  14  (which are handles is in those figures) enabling the surgeon to control and to pump air into the inflatable contour-balloon  30  and to the inflatable dissection balloon  10 . 
     The elongate open-bored applicator is activated as follows: applicator  100  is introduced into the wall of the abdominal cavity. Next, at least a portion of the inflatable dissection balloon  10  is inflated, hence thrusting. Then the inflatable contour-balloon  30  which is attached to mesh  30  is inflated to a predetermined size, such that said mesh is laying in parallel to said wall. Next, the inflatable dissection balloon  10  is deflated and evacuated throughout said applicator  100 . Finally, applicator  100  is removed and mesh  20  is fastened to the posterior abdominal wall. 
     Contour-balloon  30  and/or the inflatable dissection balloon  10  can be made of a group comprising biocompatible materials, self-dissolving materials such that after a period of time only mesh  20  stays connected to the tissue. Inflatable contour-balloon  30  can be made of shape memory materials. 
     Inflatable contour-balloon  30  may be covered with mesh  20  all-around. Furthermore, inflatable contour-balloon  30  can be removed out of the body when mesh  20  is fully spread. 
     The shape of the inflatable contour-balloon  30  and/or the inflatable dissection balloon  10  can be a polygonal shape, a curved shape, a symmetrical, a non-symmetrical shape, a linear shape, continues, non-continues, a concave shape, a irregular shape, a square-like shape, a U-like shape, a grid-like shape and a rake-like shape or any combination thereof. 
     Mesh  20  is attached to the inflatable contour-balloon  30  by means of gluing, sewing, or threading the mesh into the inflatable contour-balloon  30 . Another option to couple the mesh to the balloon is by velcro. The mesh can be attached to the inflatable contour-balloon  30  by means of gluing the balloon to the mesh such that the balloon remains in the body. Another option is to glue the mesh to the inflatable contour-balloon  30  such that the balloon can be separated from the mesh and extracted from the body. I.e., only the mesh remains in the body. The actuating means  14  can be used for extracting the inflatable contour-balloon  30  and/or the inflatable dissection balloon  10 . 
     Another option is to use the mesh as bedding for building the inflatable contour-balloon  30 . A proofing material is spread on the mesh&#39;s fibers. The inflatable contour-balloon  30  will be created by !biding the edges of mesh. 
     Both the balloons ( 30  or  10 ) can he inflated by air, CO2, saline etc. 
     Reference is now made to  FIG. 3 , which schematically presents cut view of the middle of the applicator  100  showing mesh  20 , inflatable contour-balloon  30 , inflatable dissection balloon  10  and the relation between them. 
     Reference is now made to  FIGS. 4 a    and  FIG. 4 b    displaying an applicator according to another embodiment of the present invention. According to this embodiment, the applicator additionally comprising a cover  52  and means  51  enabling the surgeon to pull aside the cover  52  from the balloons system. 
     Reference is now made to  FIG. 5 , displays the applicator according to another embodiment of the present invention. According to this embodiment, the inflatable contour-balloon  30  is positioned above the inflatable dissection balloon  10 . 
       FIG. 6 a    schematically presents a cut view in the middle of the applicator  100  according to the embodiment described in  FIG. 5 . 
       FIG. 6 b    displays the applicator according to another embodiment of the present invention. According to this embodiment, the inflatable contour-balloon  30  comprises two independent parts (as seen clearly from  FIG. 20 i    or  20   j  which display a balloon comprising several independent parts). Furthermore, the applicator according to this embodiment comprises three handles: one for the inflatable dissection balloon  10  and two for the inflatable contour-balloon (one for each part). 
     Reference is now made to  FIGS. 7 a  to 7 e   , which schematically present the mesh implanting process according to one embodiment of the present invention. According to this embodiment, the mesh is spread by using the inflatable contour-balloon  30  only (without the inflatable dissection balloon  10 ). 
     According to this embodiment, the applicator  100  comprises mesh  20  and the inflatable contour-balloon  30   
       FIG. 7 a    schematically shows the surgeon check the hernia area through the incision made by the surgeon. 
       FIG. 7 b    schematically displays the placement of applicator  100  in the incision made by the surgeon. 
     In  FIG. 7 c    the inflatable contour-balloon  30  is inflated (thus producing a cavity in which the mesh will be placed) and mesh  20  is spread in its anterior part. 
       FIG. 7 d    shows the surgeon insuring, through the incision, that mesh  20  is fully spread. 
       FIG. 7 e    shows the incision closed with stitches. 
     Reference is now made to  FIGS. 8 a  to 8 e   , which schematically present the mesh implanting process according to another embodiment of the present invention: 
     According to this embodiment, the applicator  100  comprises mesh  20 , the inflatable contour-balloon  30  and the inflatable dissection balloon  10 . 
       FIG. 8 a    represents the first step in which the applicator  100  is placed in the incision made by the surgeon. 
       FIG. 8 b    represents the second step in which the inflatable dissection balloon  10  is semi inflated starting to produce a cavity in which mesh  20  will be spread in. 
       FIG. 8 c    represents the next step in which the inflatable dissection balloon  10  is inflated and the inflatable contour-balloon  30  is inflated thus mesh  20  is spread in its anterior part. 
       FIG. 8 d    represents the next step in which the inflatable dissection balloon  10  is emptied and drawn out from the incision while mesh  20  stays spread around the incision and lying in parallel to abdominal wall. 
       FIG. 8 e    represents the last step in which the incision is closed with stitches. 
     Reference is now made to  FIGS. 9 a , 9 b  and 9 c    presenting a possible solutions or means for centering mesh  20  with respect to the inflatable dissection balloon  10 . 
     In  FIG. 9 a   , centralization of mesh  20  may be realized with wires  91  stretching from the posterior side of the inflatable dissection balloon  10  to mesh  20 . 
     Centralization of mesh  20  is realized by using Velcro and/or double sided masking tape and/or small Silicon tubes  92  that hold the mesh until the inflatable dissection balloon  10  is inflated enough to tear the connection.  FIG. 9 b    displays the inflatable dissection balloon  10  with Velcro and/or double sided masking tape and/or small Silicon tubes  92 .  FIG. 9 c    displays the inflatable dissection balloon  10  with Velcro and/or double sided masking tape and/or small Silicon tubes  92 , attached/combined/adjusted with the inflatable contour-balloon  30  and mesh  20 .  FIG. 9 d    displays the Velcro and/or double sided masking tape and/or small Silicon tubes  92  after the inflatable dissection balloon  10  is inflated enough such that the connection between the inflatable dissection balloon  10  and mesh  20  is torn apart. 
     In  FIGS. 9 e -9 f    centralization of mesh  20  is made by a ribbon  90  that surrounds the balloon and holds the mesh tight to the dissection balloon. When the inflatable dissection balloon  10  is inflated, the ribbon expands until mesh  20  is relapsed.  FIG. 9 e    displays the inflatable dissection balloon  10  is inflated such that mesh  20  is relapsed.  FIG. 9 f    displays the inflatable dissection balloon  10  prior to the inflation. 
     In  FIG. 9 g   , rigid but flexible stripes  91  are leaning on the inflatable contour-balloon  30  just like the mechanism of an umbrella, when the stripes  91  are pushed they stretch mesh  20 . The inflatable dissection balloon  10  makes room in between the tissues and strengths the central part of the mesh  20 . 
     Reference is now made to  FIGS. 10 a -10 g    presenting possible designs of the inflatable dissection balloon  10  and possible coupling options between said inflatable balloon  10  and the mesh  20 . As can be seen from the figures tube  101  is used to inflate the inflatable dissection balloon  10  and tube  102  is used to inflate the inflatable contour-balloon  30 . 
     As can be seen from  FIGS. 10 a  and 10 b    the inflatable dissection balloon  10  surrounds mesh  20  and the inflatable contour-balloon  30 . 
     In  FIGS. 10 a -10 b    mesh  20  and the inflatable contour-balloon  30  are positioned in the internal portion of the inflatable dissection balloon  10 .  FIG. 10 a    is a cut view of the same. 
     in  FIG. 10 c    mesh  20  and the inflatable contour-balloon  30  are positioned in the internal portion of the inflatable dissection balloon  10 .  FIG. 10 d    is a cut view of the same. The difference between  FIGS. 10 a  and 10 e    is the location of the two balloon with respect to each other. In  FIGS. 10 a  and 10 b    the inflatable dissection balloon  10  surrounds mesh  20  and the inflatable contour-balloon  30  from bellow and in  FIGS. 10 c  and 10 d    the inflatable dissection balloon  10  surrounds mesh  20  and the inflatable contour-balloon  30  from above. 
     In  FIG. 10 e    mesh  20  and the inflatable contour-balloon  30  are positioned in the inner portion  103  of the inflatable dissection balloon  10 . 
     In  FIG. 10 f    mesh  20  and the inflatable contour-balloon  30  are incorporated within inflatable dissection balloon  10 . Figure lOg is a cut view of the same. 
     Reference is now made to  FIGS. 11 a -11 d    presenting possible valve designs for sealing the airway of the inflatable contour-balloon  30 : 
       FIG. 11 a    displays a possible valve design according to one embodiment of the present invention. According to this embodiment, a rigid tube  110  in inserted into the flexible inflating tube  101  The inside portion of the tube  102  is covered with glue  111 . When the rigid tube  110  is drawn out of the flexible inflating tube  102 , the inside portion of said tube  102  stick together and do not allow air to escape. 
       FIG. 11 b    displays another possible design of a valve. In this embodiment, the valve is made of a rigid tube  113 . The rigid tube  113  is positioned inside the flexible inflating tube  102 . In the inside of the flexible inflating tube  102  there are leafs  114  covered with glue. When the rigid tube  113  is drawn out of the flexible inflating tube  102 , leafs  114  inside the inflating tube  102  expand and stick to each other and thus do not allow air to escape. 
       FIGS. 11 c  and 11 d    display a rubber band  115  positioned around the rigid tube  116 . When the rigid tube  116  is drawn out of the flexible inflating tube  102  (see  FIG. 11 d   ), the rubber band  116  applies force on the flexible inflating tube  102  and thus do not allow air to escape. 
     Reference is now made to  FIG. 12 , which presents a possible design a handle which is also used as an air pump. The air pump can be used either to pump air or to empty the air out of the inflatable contour-balloon  30 . 
     Reference is now made to  FIG. 13 , which schematically displays different designs of the inflatable contour-balloon  30 . 
     The inflatable contour-balloon  30  may have a flat structure as displays in  FIGS. 13 a , 13 b , 13 c   , or a 3D structure as displays in  FIGS. 13 d , 13 e    and  13   f.    
     The inflatable contour-balloon  30  may not have a complete closed shape as can be seen in  FIGS. 13 g  and 13 h   . The different parts of the inflatable balloon may be connected to each other with glue, wire, scotch Etc. 
     The inflating tube  102  may be flexible ( FIG. 13 i   ), or rigid ( FIG. 13 j   ). Moreover, the inflating tube  102  may not be connected to the center of the balloon  30 .  FIG. 13 k    represents a different design for the inflatable contour-balloon  30 . According to this design, inflatable contour-balloon  30  has two parts. An internal pad  31  and an external part  32 . Mesh  20  is positioned in between the internal part  31  and the external part  32 . An inflating tube  102  is coupled to a tube  34 , which passes through both the internal part  31  and the external part  32 ,  FIG. 13I  is a cross section area of the same. 
     In another embodiment of the invention the  2  balloons may be inflated with different pumps allowing the use of sequenced pumping. 
       FIG. 13 m    represent another different design for the inflatable contour-balloon  30 . According to this design, the inflatable contour-balloon  30  encapsulate an internal balloon  40  shaped as an o-ring. Mesh  20  is captured in between the inflatable contour-balloon  30  and the internal balloon  40 .  FIG. 13 n    is a cut and an enlarge view of the same.  FIG. 13 o    displays the inflatable contour-balloon  30  and the internal balloon  40  according to this design. 
     Reference is now made to  FIGS. 14, 15 and 16 , which schematically display different rectangle shapes of the inflatable contour-balloon  30  and mesh  20 . 
     As can be seen from  FIG. 14 , the shape of the inflatable contour-balloon  30  is a rectangle shape having two oppositely faced curves. The two curves can be fused one to the other in a common section. Additionally, according to this embodiment mesh  20  is threaded in slits  7  which are positioned in two oppositely sides ribs on the rectangle. Inflating tube  102  is connected to inflatable contour-balloon  30 . An inflating pump  14  is connected to the inflating tube  102 . 
     Reference is now made to  FIG. 15 , which schematically represents the inflatable contour-balloon  30  and the mesh  20  according to another embodiment of the present invention. According to this embodiment mesh  20  extends beyond the inflatable contour-balloon  30 . 
     Reference is now made to  FIG. 16 , which schematically represents the inflatable contour-balloon  30  and the mesh  20  according to another embodiment of the present invention. 
     Reference is now made to  FIG. 17 , which schematically represents the inflatable contour-balloon  30  and mesh  20  according to another embodiment of the present invention. According to this embodiment, the inflatable contour-balloon  30  additionally comprises two arcs  10  that may replace the function of the dissection balloon. The inflatable contour-balloon  30  is fixed to its position, by creating pressure on the mesh/patch towards the abdominal wall. 
     Reference is now made to  FIG. 18 , which displays an option of attaching mesh  20  to the inflatable contour-balloon  30 . According to that embodiment, the inflatable contour-balloon  30  additionally comprises at least one slit  7  into which the edges of mesh  20  are threaded.  FIG. 19  displays the inflatable contour-balloon  30  with mesh  20  threaded inside the slits.  FIG. 20 a    and  FIG. 20 b    display a more detail look of the same. 
     Another way of coupling between the inflatable contour-balloon  30  and the mesh is by making specials cuts in the mesh such that those cute surround the balloon as can be seen from  FIGS. 20 c    and  20   d.    
     Another way to attach the inflatable contour-balloon  30  to the mesh is by double-sided adhesive material as displayed in  FIG. 20 e   .  FIG. 20 f    displays another design of the inflatable contour-balloon  30  and mesh  20 . 
     Another option to couple the inflatable contour-balloon  30  and mesh  20  is by using special extensions  11  as can be seen in  FIGS. 20 g  and 20 h   . The special extensions  11  are insertable into extension  18  in the mesh  20 . The inflatable contour-balloon  30  can additionally comprise means  25  (such as bulge, lines, signs and symbols) adapted to adjust the center of said inflatable balloon to the center of the hernia. 
     Reference is now made to  FIG. 20 i   , which schematically displays the inflatable contour-balloon  30 , which comprises several independent parts  40  and several inflating tubes  102  (which will be couple to the inflating means). As can be seen from  FIG. 20 i    tubes  102  are not positioned in the center of the balloon. 
     Reference is now made to  FIG. 20 j   , which schematically displays the inflatable contour-balloon  30  comprising several independent parts  40  and several inflating As can he seen from  FIG. 20 i    tubes  102  are not radial. I.e., tubes  102  are positioned in the perimeter of the inflatable balloon.