Abstract:
A surgical mesh, having a mesh material having a first leaf, a second leaf, and a third leaf. The first leaf having first leaf targets disposed thereon, the second leaf having second leaf targets disposed thereon, the third leaf having third leaf targets disposed thereon. The leafs may also have an orientation line longitudinally disposed thereon. A surgeon can use the targets to identify the location of where to apply sutures through the mesh material to the patient to remedy prolapse.

Description:
GOVERNMENT RIGHTS 
       [0001]    This invention was not made with Government support under. The Government does not have any rights in this invention. 
       BACKGROUND OF THE INVENTION 
       [0002]    Uterine prolapsed occurs when the uterus slips downward into the vagina. Slight prolapsed may be unnoticeable, but the uterus may drop down so far that its bottom portion, the cervix, is felt as a round bulge at or coming out of the vaginal opening. 
         [0003]    In women who have had a hysterectomy, the top part of the vagina may prolapse into the lower vagina. 
         [0004]    Surgery may be required to return the organs to their correct anatomical positions and retain them in place. 
         [0005]    Per the National Center for Health Statistics, Hysterectomy Surveillance, U.S., 1994-1999; it is estimated that over 120,000 cases of uterine and vaginal vault prolapse are surgically treated each year in the U.S. 
         [0006]    Sacrocolpopexy is a method of correcting prolapse by using mesh to hold the vagina in an improved anatomical position. The mesh can be applied to reposition or hold the vagina from either an open surgery incision, which may be a 15-30 cm horizontal incision, or smaller incisions, which are less invasive than the procedure using the open surgery incision. This less invasive procedure results in less blood loss and less scarring. The less invasive procedure may use instruments such as monopolar curved scissors, bipolar forceps, needle drivers, dissectors, drivers, fenestrated graspers, or cadiere forceps. 
         [0007]    The mesh material may be sutured to the vagina, specifically the anterior vaginal wall or portion, the posterior vaginal wall or portion, and the longitudinal ligament, to reposition and hold the vagina in place. The procedure is physically challenging because of the small working environment and the limited camera viewing area of the mesh and internal organs. With small working conditions and a limited field of visibility, it is possible for the mesh to be secured to an organ in a way that applies unequal forces on the mesh and the organ, reducing the longevity of the mesh and the operation, which may result in a higher failure rate or resulting in subsequent surgeries. 
         [0008]    As can be seen, there is a need for a surgical procedure and mesh that allows surgeons to apply sutures through targeted locations on the mesh that improve the visibility of suture location during surgery. There is also a need to enable surgeons to apply sutures through targets that are positioned to apply substantially equal forces on the mesh and organ. This improved positioning decreases creased or folded mesh. This improved positioning results in mesh that is secured to the vagina with substantially equal forces, which increases the holding and longevity of the mesh and organ. 
         [0009]    There is also a need to improve visual orientation for fast, enhanced and secure repair. There is a need to facilitate precise, highly effective suture placement at anatomically correct pelvic organ prolapsed involving the vaginal apex. There is a need to reduce operating room (O.R.) time. There is also a need to increase safety. There is a need for a simple solution in mesh delivery and orientation. There is a need for ease in tailoring the size of the mesh done intracorporeally as necessary by using targets. There is a need to suture through marked targets to distribute equal forces. There is a need to improve mesh alignment to increase efficiency. There is also a need to maintain equal tension on the anterior and posterior vaginal wall. There is a need to decrease the failure rate. In addition, there is a need for the symmetrical placement of the sutures. 
       SUMMARY OF THE INVENTION 
       [0010]    An aspect of the present invention comprises a surgical mesh ( 10 ), comprising a first leaf ( 20 ) having a first leaf proximal end ( 22 ); a second leaf ( 30 ) having a second leaf proximal end ( 32 ); a third leaf ( 40 ) having a third leaf proximal end ( 42 ); said first leaf proximal end ( 22 ) disposed near said second leaf proximal end ( 32 ); said second leaf proximal end ( 32 ) disposed near said third leaf proximal end ( 42 ); a target ( 48 ) disposed on at least one of either said first leaf ( 20 ), said second leaf ( 30 ), or said third leaf ( 40 ). 
         [0011]    Another aspect of the present invention is a surgical method ( 200 ) of applying a surgical mesh ( 10 ) to a patient, comprising the steps attaching a third leaf ( 40 ) to an organ ( 210 ) by using a third leaf target ( 70 ) as a reference point; attaching a second leaf ( 30 ) to an organ ( 220 ) by using a second leaf target ( 60 ) as a reference point; and attaching a first leaf ( 20 ) to an organ by using a first leaf target ( 50 ) as a reference point. 
         [0012]    A third aspect of the present invention is a surgical mesh ( 10 ), comprising: a mesh material ( 90 ) having a first leaf ( 20 ), a second leaf ( 30 ), and a third leaf ( 40 ), said first leaf ( 20 ) having an orientation line ( 100 ) disposed on at least one of said first leaf ( 20 ), said second leaf ( 30 ), or said third leaf ( 40 ). 
         [0013]    These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description and claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  is a pictorial of an embodiment of the surgical mesh of the present invention; 
           [0015]      FIG. 2  is a pictorial of the leafs of an embodiment of the surgical mesh of the present invention;  FIGS. 2A  is the first leaf;  2 B the second leaf; and  2 C the third leaf; 
           [0016]      FIG. 2  is a pictorial of the leafs of an embodiment of the surgical mesh of the present invention;  FIGS. 2A  is the first leaf;  2 B the second leaf; and  2 C the third leaf; 
           [0017]      FIG. 3  is a pictorial of an embodiment of the mesh material and target of the present invention; 
           [0018]      FIG. 4  is a schematic of a method of surgery of the present invention; and 
           [0019]      FIG. 5  is a pictorial of the mesh applied on a patient. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0020]    The following detailed description is of the best currently contemplated modes of carrying out the invention. The description is not to be taken in a limiting sense, but is made merely for illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims. 
       REFERENCE NUMERALS 
       [0021]      10  surgical aid 
         [0022]      20  first leaf 
         [0023]      22  first leaf proximal end 
         [0024]      24  first leaf edge 
         [0025]      26  first leaf middle portion 
         [0026]      30  second leaf 
         [0027]      32  second leaf proximal end 
         [0028]      34  second leaf edge 
         [0029]      36  second leaf row 
         [0030]      48  target 
         [0031]      50  first leaf target 
         [0032]      60  second leaf target 
         [0033]      70  third leaf target 
         [0034]      80  aperture or pore 
         [0035]      90  mesh material 
         [0036]      100  orientation line 
         [0037]      120  first orientation line 
         [0038]      130  second orientation line 
         [0039]      140  third orientation line 
         [0040]      200  surgical method 
         [0041]      210  attaching the third leaf  40  to an organ 
         [0042]      220  attaching the second leaf  30  to an organ 
         [0043]      230  attaching the first leaf  20  to an organ 
         [0044]      FIG. 1  illustrates one embodiment of the present invention surgical material  10 , also referred to herein as surgical mesh  10 . One embodiment of the surgical material  10  or surgical mesh may have a first leaf  20 ; the first leaf  20  may have a first leaf proximal end  22 . A second leaf  30  may have a second leaf proximal end  32 . A third leaf  40  may have a third leaf proximal end  42 . The first leaf proximal end  22  may be connected to the second leaf proximal end  32  or the third leaf proximal end  42 , or both the second leaf proximal end  32  and the third leaf proximal end  42 . The third leaf proximal end  42  may be connected to either the first leaf proximal end  22 , or the second leaf proximal end  32 , or both. 
         [0045]    The first leaf  20 , second leaf  30 , and third leaf  40  may be constructed of a mesh material  90  in one embodiment. In one embodiment, the mesh material  90  may be a large pore polypropylene mesh. One suitable type of large pore polypropylene mesh is IntePro™ of American Medical Systems, Inc. of Minnetonka, Minn. The mesh material  90  may also be a mesh elastic-elastic lightweight and large pore polypropylene, such as Optilene® of Aesculap, Inc., Center Valley, Pa. 
         [0046]    A target  48 , such as a first leaf target  50  may be disposed on the first leaf  20 . The first leaf target  50  may be made of thread, or any suitable material that allows suturing therethrough. The first leaf target  50  may be made of the same mesh material  90  as the first leaf  20 . The first leaf target  50  may be a different color than the remainder of the first leaf  20 . In one embodiment, the first leaf target  50  may be green. The target  48 ,  50 ,  60 ,  70  may be visible from both sides of the respective leaf  20 ,  30 ,  40 . The target  48 ,  50 ,  60 ,  70  may be visible on both sides of the respective leaf  20 ,  30 ,  40 . 
         [0047]    The first leaf  20  may also be referred to as the sacral wall leaf  20  because the first wall leaf  20  or first leaf  20  may be attached to the longitudinal ligament of the patient. As illustrated in  FIG. 2A , the first leaf  20  may taper as the sacral leaf extends away from a sacral leaf proximal end  22 . 
         [0048]    In one embodiment the first leaf  20  may be about 4.5 inches long by about 1.5 inches wide. 
         [0049]    In one embodiment the first leaf  20  may have green targets  50  because the word longitudinal has a “g” in it and the word “green” starts with a “g so the surgeon can possibly more easily know that the first leaf  20  is sutured to the longitudinal ligament. 
         [0050]    Similarly, a target  48 , such as a second leaf target  60  may be disposed on the second leaf  30 . The second leaf target  60  may be made of thread  100  or any material that allows suturing therethrough. The second leaf target  60  may be the same mesh material  90  as the second leaf  30 . The second leaf target  60  may be a different color than the remainder of the second leaf  30 . The second leaf target  60  may be a different color than the first leaf target  50 . In one embodiment the second leaf target  60  may be the color red. The second leaf target  60  may be red because the second leaf  30  may be sutured to the posterior wall of the vagina, which may be close to the rectum, and the word “rectum” and “red” both start with the letter “r” so that the surgeon can possibly easily identify that the leaf with the red target  60  is sutured to the wall near the rectum of the patient. 
         [0051]    The second leaf  30  may also be referred to as the posterior wall leaf  30  because the posterior wall leaf  30  may be attached to the posterior vaginal wall or the rectum of the patient. 
         [0052]    In one embodiment the second leaf  30  may be about 3 inches long by about 1.5 inches wide. 
         [0053]    A target  48 , such as a third leaf target  70 , may be disposed on the third leaf  40 , also referred to as the anterior wall leaf  40 . The third leaf target  60  may be made of thread  100 . The third leaf target  70  may be the same mesh material  90  as the third leaf  40 . The third leaf target  70  may be a different color than the remainder of the third leaf  40 . The third leaf target  70  may be a different color than the first leaf target  50 . The third leaf target may be a different color than the second leaf target  60 . In one embodiment the third leaf target  70  may be blue. The third leaf target  70  may be blue because the third leaf  40 , also referred to herein anterior wall leaf  40  is close to the bladder; and the word “bladder” and “blue” both start with the letter “b.” 
         [0054]    The third leaf  40  may also be referred to as the anterior wall leaf  40  because the anterior wall leaf  40  may be attached to the anterior vaginal wall or the bladder of the patient. 
         [0055]    In one embodiment the third leaf  40  may be about 3 inches long by about 1.5 inches wide. 
         [0056]    As illustrated in  FIG. 2A  the first leaf  20  may have a single row of first leaf targets  50  disposed along a first leaf middle portion  26  of the first leaf  20 . 
         [0057]    As illustrated in  FIG. 2B  the second leaf  30  may have two second leaf rows  36  of second leaf targets  60  disposed thereon. Each second leaf row  36  may be disposed about 1.5 cm from the second leaf edge  34 . The second leaf edge  34  may be disposed about the perimeter of the second leaf  30 . Alternatively each second leaf row  36  may be disposed so that there are at least two apertures  80  or pores  80  from the third second leaf edge  34  to the target  60 , as illustrated in  FIG. 3 . 
         [0058]    As illustrated in  FIG. 2C  the third leaf  40  may have two third leaf rows  46  of third leaf targets  70  disposed thereon. Each third leaf row  46  may be disposed about 1.5 com from the third leaf edge  44 . The third leaf edge  44  may be disposed about the perimeter of the third leaf  40 . Alternatively each third leaf row  46  may be disposed so that there are at least two apertures  80  or pores  80  from the third leaf edge  44  to the target  70 , as illustrated in  FIG. 3 . 
         [0059]    As illustrated in  FIG. 3 , in one embodiment the respective targets  50 ,  60 ,  70  are disposed with at least 2 apertures or pores  80  inwardly from the respective edge  24 ,  34 ,  44 , such as the first leaf edge  24 , the second leaf edge  34 , or the third leaf edge  44 . This may reduce tears of the mesh material  90  and provide for a more stable attachment of the mesh material  90  to the organ of the patient. 
         [0060]    In another embodiment the targets  50 ,  60 ,  70  may be disposed inwardly from the respective edges  24 ,  34 ,  44  by a distance of about 1.5 cm. In other words, there may be a distance of about 1.5 cm of mesh material  90  from an edge of the target  50 ,  60 ,  70  to the respective edge  24 ,  34 ,  44  of the mesh material  90 . The present invention may be used with mesh material  90  having different sized apertures  80 ; or with differently sized mesh material  90 . 
         [0061]    In one embodiment the second leaf  30  or posterior wall leaf  30  may be longer than the third leaf  40  or the anterior wall leaf  40 . 
         [0062]    As illustrated in  FIGS. 1 ,  2 B, and  2 C, an orientation line  100  may be disposed longitudinally along at least one of first leaf  20 , second leaf  30 , or third leaf  40 . The first leaf  20  may have a first orientation line  120  disposed longitudinally thereon. The second leaf  30  may have a second orientation line  130  disposed longitudinally thereon. The third leaf  40  may have a third orientation line  140  disposed longitudinally thereon. The orientation line  100 ,  120 ,  130 ,  140  may be visible from either side of the respective leaf  20 ,  30 ,  40 . The orientation line  100 ,  120 ,  130 ,  140  may be visible on both sides of the respective leaf  20 ,  30 ,  40 . 
         [0063]    In one embodiment the first orientation line  120  is the same color as the first leaf target  50 . In one embodiment the second orientation line  130  is the same color as the second leaf target  60 . In one embodiment the third orientation line  140  is the same color as the third leaf target  70 . The first orientation line  120  may be disposed along the middle portion of the first leaf  20  and may bisect the leaf forming two substantially equal halves on each side of the first orientation line  120 . The second orientation line  130  may be disposed along the middle portion of the second leaf  30  and may bisect the leaf forming two substantially equal halves on each side of the second orientation line  130 . The third orientation line  140  may be disposed along the middle portion of the third leaf  40  and may bisect the leaf forming two substantially equal halves on each side of the third orientation line  140 . 
         [0064]      FIG. 4  illustrates one embodiment of performing the surgical method  200  with the surgical mesh  10  of the present invention. One embodiment may include the following steps: 
         [0065]      210  attaching the third leaf  40  to an organ by using the third leaf target  70  as a reference point; 
         [0066]      220  attaching the second leaf  30  to an organ by using the second leaf target  60  as a reference point; 
         [0067]      230  attaching the first leaf  20  to an organ by using the first leaf target  50  as a reference point. 
         [0068]    In one embodiment the targets  70 ,  60 ,  50  may be used as reference points by placing sutures through the respective reference point to the organ of the patient. 
         [0069]    In one embodiment the step  210  may include the third leaf  40  attached to the anterior vaginal wall, in step  220  the second leaf  30  may be attached to the posterior vaginal wall, and in step  230  the first leaf  20  may be attached to the sacrum. 
         [0070]    The attaching of the three leafs  40 ,  30 ,  20  may be accomplished by suturing thread through the targets  70 ,  60 ,  50  and through the respective organ of the patient so that the surgical mesh  10  holds and maintains the organs in an acceptable anatomical position. 
         [0071]      FIG. 5  illustrates the mesh  10  of the present invention as applied on a patient. 
         [0072]    It should be understood, of course, that the foregoing relates to exemplary embodiments of the invention and that modifications may be made without departing from the spirit and scope of the invention as set forth in the following claims.