Abstract:
In one aspect, the present invention is directed to an implant ( 10 ) for supporting the pelvic floor, the implant ( 10 ) consisting essentially of (FIGS.  1, 12, 16, 18 ): one or more straps ( 40, 48 A,  48 B,  48 C) having a width of less than 25 millimeter, for anchoring the ends ( 86 ) thereof to a pelvis, thereby providing a low-mass implant ( 10 ) to avoid mesh related adverse effects.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to the field of pelvic floor reconstruction. In particular, the present invention relates to the field of pelvic floor reconstruction using implants. 
       BACKGROUND OF THE INVENTION 
       [0002]    Pelvic organ prolapse (POP) is a common female problem that can have a profound impact on a woman&#39;s quality of life. 
         [0003]    The organs in the pelvic cavity, uterus, vagina, bladder and rectum, are held in place by a web of muscles and connective tissues that act much like a hammock. When these muscles and tissues become weakened or damaged, one or more of the pelvic organs shift out of normal position and literally “fall” into the vagina. 
         [0004]    Modern prolapse surgical reconstruction is performed through the vagina. During the procedure, the surgeon repositions the prolapsed organs, securing them to surrounding tissues and ligaments. 
         [0005]    Commonly a synthetic non-absorbable polypropylene mesh implant shaped as a plain sheath surface is used. 
         [0006]    However, the prior art surgical procedures using mesh implants shaped as plain sheath surface do not provide reliable anchoring. One of their disadvantages is their high mass. 
         [0007]    It is an object of the present invention to provide a reliable anchoring of the mesh implant. 
         [0008]    Other objects and advantages of the invention will become apparent as the description proceeds. 
       SUMMARY OF THE INVENTION 
       [0009]    The phrase “consisting essentially of” limits the scope to the specified element(s). 
         [0010]    In one aspect, the present invention is directed to an implant ( 10 ) for supporting the pelvic floor, the implant ( 10 ) consisting essentially of ( FIGS. 1 ,  12 ,  16 ,  18 ):
       one or more straps ( 40 ,  48 A,  48 B,  48 C) having a width of less than 25 millimeter, for anchoring the ends ( 86 ) thereof to a pelvis,
 
thereby providing a low-mass implant ( 10 ) to avoid mesh related adverse effects.
       
 
         [0012]    The one or more straps ( 40 ,  48 A,  48 B,  48 C) may comprise (FIGS.  1 , 3 ):
       a mother strap ( 40 ),
 
wherein the length thereof is adapted to anchor, by the ends ( 86 ) thereof, the two sacrospinous ligaments ( 22 ) of the pelvis, and to support the uterine cervix ( 20 ) in between,
 
thereby allowing supporting the central compartment of the pelvic floor.
       
 
         [0014]    The one or more straps ( 40 ,  48 A,  48 B,  48 C) may further comprise ( FIGS. 12 ,  13 ):
       a second strap ( 48 A), extending approximately from the center of the mother strap ( 40 ), the length of the second strap ( 48 A) thereof adapted to anchor the perineal body ( 26 ),
 
thereby allowing supporting the central and posterior compartments of the pelvic floor.
       
 
         [0016]    The one or more straps ( 40 ,  48 A,  48 B,  48 C) may further comprise ( FIGS. 12 ,  14 ):
       a first pair of straps ( 48 A), each strap thereof extending approximately from the center of the mother strap ( 40 ), the length of each the strap adapted to anchor by the end ( 86 ) thereof, one arcus tendineous fascia pelvic (ATFP) ligament ( 24 ),
 
thereby allowing supporting the central and anterior compartments of the pelvic floor.
       
 
         [0018]    Each of the one or more straps ( 40 ,  48 A,  48 B,  48 C) may comprise a loop ( 34 ) at the end ( 86 ) thereof, for being trapped (FIGS.  4 , 5 ) by a needle ( 70 ) and for being released ( FIG. 7 ) within the pelvic area after threading ( FIG. 6 ) the end ( 86 ) into a tissue ( 22 , 24 ,  26 ), 
         [0000]    thereby allowing reliable anchoring of the end ( 86 ) to the pelvis. 
         [0019]    The mother strap ( 40 ) may comprise a loop ( 32 ), for fixing the utero-cervical fibrotic ring ( 20 ). 
         [0020]    The at least first pair of straps ( 48 A) extending from the mother strap ( 40 ) may comprise ( FIG. 12 ) a third strap ( 49 A) in between, thereby providing additional support. 
         [0021]    The central and anterior embodiment may further comprise ( FIGS. 16 ,  17 ):
       a second strap ( 48 A), extending approximately from the center of the mother strap ( 40 ), the length of the second strap ( 48 A) thereof adapted to anchor the perineal body ( 26 ),
 
thereby allowing supporting the central, posterior and anterior compartments of the pelvic floor.
       
 
         [0023]    The one or more straps or straps ( 40 ,  48 A,  48 B,  48 C) may further comprise ( FIG. 18 ,  19 ):
       a second pair of straps ( 48 C), each strap thereof extending approximately from the center of the mother strap ( 40 ), the length of each the strap adapted to anchor by the end ( 86 ) thereof, one arcus tendineous fascia pelvic (ATFP) ligament ( 24 ),
 
thereby providing
 
the first pair of straps ( 48 A) anchoring the arcus tendineous fascia pelvic (ATFP) ligaments ( 24 ) close to the obturator foramen covered with the obturator pascia ( 16 ), and
 
the second pair of straps ( 48 C) anchoring the arcus tendineous fascia pelvic (ATFP) ligaments ( 24 ) close to the iscial spine bone ( 14 ).
       
 
         [0025]    The reference numbers have been used to point out elements in the embodiments described and illustrated herein, in order to facilitate the understanding of the invention. They are meant to be merely illustrative, and not limiting. Also, the foregoing embodiments of the invention have been described and illustrated in conjunction with systems and methods thereof, which are meant to be merely illustrative, and not limiting. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0026]    Embodiments and features of the present invention are described herein in conjunction with the following drawings: 
           [0027]      FIG. 1  illustrates a mother implant, according to one embodiment of the present invention. 
           [0028]      FIG. 2  is an anterior view of the pelvic area before installing any implant. 
           [0029]      FIG. 3  illustrates the view of  FIG. 2  after installing the implant of  FIG. 1 . 
           [0030]      FIG. 4  illustrates the head of a needle for threading the ends of the implant of  FIG. 1 . 
           [0031]      FIG. 5  illustrates the first step of threading the strap of the implant, using the needle of  FIG. 4 . 
           [0032]      FIG. 6  illustrates the second step of threading the strap of the implant, using the needle of  FIG. 4 . 
           [0033]      FIG. 7  illustrates the third step of threading the strap of the implant, using the needle of  FIG. 4 . 
           [0034]      FIG. 8  illustrates the fourth step of threading the straps of the implants, using the needle of  FIG. 4 . 
           [0035]      FIG. 9  illustrates the needle of  FIG. 4  and its operation. 
           [0036]      FIG. 10  illustrates the operation of the needle of  FIG. 6  in respect of the surgeon&#39;s access to the pelvic area. 
           [0037]      FIG. 11  illustrates the operation of the needle of  FIG. 4  threaded into another ligament. 
           [0038]      FIG. 12  illustrates an implant for posterior or anterior reinforcement according to another embodiment of the present invention. 
           [0039]      FIG. 13  depicts the view of  FIG. 2  after installing the implant of  FIG. 12 . 
           [0040]      FIG. 14  depicts the view of  FIG. 2  after installing the implant of  FIG. 12 , according to another embodiment. 
           [0041]      FIG. 15  depicts the installation of  FIG. 14  having the additional strap. 
           [0042]      FIG. 16  illustrates an implant according to another embodiment of the present invention. 
           [0043]      FIG. 17  depicts the view of  FIG. 2  after installing the implant of  FIG. 16 . 
           [0044]      FIG. 18  illustrates an implant according to another embodiment of the present invention. 
           [0045]      FIG. 19  depicts the view of  FIG. 2  after installing the implant of  FIG. 18 . 
       
    
    
       [0046]    It should be understood that the drawings are not necessarily drawn to scale. 
       DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0047]    The present invention will be understood from the following detailed description of preferred embodiments, which are meant to be descriptive and not limiting. For the sake of brevity, some well-known features, methods, systems, procedures, components, circuits, and so on, are not described in detail. 
         [0048]    The present invention provides an implant for supporting a female pelvic floor, having a lower mass than prior art implants. The low mass feature may avoid mesh related adverse effects. 
         [0049]    In order to obtain this advantage, the inventive implant does not include any plain sheath surface, but rather relatively narrow straps only. 
         [0050]    Thus, the inventive implant functions as a harness, rather than being an encasement for the supported organs. 
         [0051]    The following text associates each strap to the pelvic support thereof, disclosing that narrow straps only may also provide sufficient and improved pelvic support. 
         [0052]      FIG. 1  illustrates a mother implant according to one embodiment of the present invention. 
         [0053]    An implant  10  includes a single strap  40  ending with ends  86 . Implant  10  may also include a loop  32  at the center and loops  34  at the ends thereof. 
         [0054]    Implant  10  does not include plain sheath surfaces, but only narrow strap  40  or additional straps. The width of strap  40  does not exceed 25 millimeter, thus the mass of implant  10  is reduced in relation to prior art implants. 
         [0055]      FIG. 2  is an anterior view of the pelvic area before installing any implant. 
         [0056]    The anterior view of the pelvic area refers to the front, allowing surgical access through the patient&#39;s vaginal opening 
         [0057]    The ischial spine bone  14  and sacrum bone  12  are depicted extending from the posterior border of the bony pelvis  30 . 
         [0058]    The perineal body  26  is located at the posterior compartment of the pelvic area. 
         [0059]    The uterine cervix and utero-cervical fibrotic ring  20 , extending from the uterus (womb)  18 , and the two ligaments of the sacrospinous (SS)  22  are located substantially at the central section of the pelvic area, at the posterior apical part of the pelvic floor connecting the sacrum and the iliac spine. 
         [0060]    The two ligaments of the arcus tendineous fascia pelvic (ATFP)  24  are located at the anterior compartment of the pelvic area, and connect the iliac spine to the obtorator area. 
         [0061]      FIG. 3  illustrates the view of  FIG. 2  after installing the implant of  FIG. 1 . 
         [0062]    Implant  10  of  FIG. 1  is used for reconstructing the central section of the pelvic floor, supporting the uterine cervix and utero-cervical fibrotic ring  20 . 
         [0063]    Each of the two ends  86  of the single strap of implant  10  together with the loop  34  thereof is threaded into one sacrospinous ligament  22 . Thus, each end  86  of implant  10  is anchored to one sacrospinous ligament  22 . 
         [0064]    The anchoring is adjusted such that central loop  32  of implant  10  is fixed to uterine cervix and utero-cervical fibrotic ring  20 , supports it and preferably holds it. Central loop  32  of implant  10  may be sutured to uterine cervix  20  or to the location vaginal apex and/or naturally adhered after long term attachment, and/or immediately adhered by a biological adhesive, glue, tuckers, sutures, or just placing and depending upon natural adhesion, or any other attachment. 
         [0065]    Since the mass of strap  40  is smaller than prior art mesh implants, the anchoring thereof is safer and less related to adverse effects. 
         [0066]      FIG. 4  illustrates the head of a needle for threading the ends of the implant of  FIG. 1 . 
         [0067]    A needle  70  may be used for threading ends  86  of implant  10  or other ends of other implants through ligaments  22  and/or through other places. 
         [0068]    The head of needle  70  includes a rod  78 , which may be manually slid back and forth within a body  72 . 
         [0069]    The edge of rod  78  may be inserted into a niche  74 . The tip  76  of needle  70  is located at the edge of body  72 . 
         [0070]      FIG. 5  illustrates the first step of threading the strap of the implant, using the needle of  FIG. 4 . 
         [0071]    The surgeon inserts loop  34  of strap  40  into niche  74 , and traps the edge of rod  78  into loop  34 . 
         [0072]      FIG. 6  illustrates the second step of threading the strap of the implant, using the needle of  FIG. 4 . 
         [0073]    The surgeon then pushes tip  76  together with body  72  into ligament  22  or into another ligament, threading loop  34  and strap  30  therethrough. 
         [0074]      FIG. 7  illustrates the third step of threading the strap of the implant, using the needle of  FIG. 4 . 
         [0075]    The surgeon then slides rod  78  out of niche  74 , releasing loop  34 . 
         [0076]      FIG. 8  illustrates the fourth step of threading the straps of the implants, using the needle of  FIG. 4 . 
         [0077]    The surgeon then pulls body  72 , together with tip  76 , out of ligament  22 . Strap  40  remains threaded while tip  76  exits. 
         [0078]      FIG. 9  illustrates the needle of  FIG. 4  and its operation. 
         [0079]    The surgeon holds handle  80  of needle  70 , and slides rod  78  by toggling a toggle arm  82 , which is connected to rod  78 . 
         [0080]    Since tip  76  is inserted into the pelvic area, and toggle arm  82  is far away from tip  76 , toggle arm  82  is located outside the body of the patient and may be located farther and outside the surgical area. 
         [0081]    Thus, the surgeon can thread strap  40  from the side having surgical access, without requiring any additional perforations of the body from the opposing direction. 
         [0082]      FIG. 10  illustrates the operation of the needle of  FIG. 6  in respect of the surgeon&#39;s access to the pelvic area. 
         [0083]      FIG. 11  illustrates the operation of the needle of  FIG. 4  threaded into another ligament. 
         [0084]    The surgeon inserts finger  84  thereof in vaginal incision into the pelvic area (the lines of the parts inside are dashed). The surgeon may trap loop  34  to niche  74  of needle  70 , then penetrate tip  76  through ligament  22  or  24  and pushes into the desired depth; then releases loop  34  from needle  70  by toggling toggle arm  82 , using the other hand thereof. The surgeon can then pull tip  76  back, leaving loop  34  and strap  30  at the side beyond, based on the shrinking of ligament  22  or  24  towards strap  30  at the threaded point. 
         [0085]      FIG. 12  illustrates an implant for posterior or anterior reinforcement according to another embodiment of the present invention. 
         [0086]    Implant  10  according to this embodiment includes, except for strap  40  ending with ends  86  and loop  32  at the center, also two additional straps  48 A, each extending substantially perpendicularly from strap  40 . 
         [0087]    Since straps  48 A and other straps extend from strap  40 , strap  40  is herein named “mother strap”. 
         [0088]    Each of straps  48 A may also include a loop  34  at the end thereof. 
         [0089]    According to one embodiment, an additional strap  49 A may cross between the perpendicular straps  48 A, for limiting the distance therebetween. 
         [0090]      FIG. 13  depicts the view of  FIG. 2  after installing the implant of  FIG. 12  on the central and posterior compartments. 
         [0091]    Implant  10  of  FIG. 12  is used for reconstructing the central and the posterior compartment of the pelvic floor, supporting the uterine cervix and utero-cervical fibrotic ring  20  and/or the location vaginal apex, the small intestine and the rectum. 
         [0092]    Each of the two ends  86  of the mother strap  40  together with the loop  34  thereof is threaded into one sacrospinous ligament  22 . Implant  10  is then adjusted between sacrospinous ligaments  22  such that loop  32  of implant  10  thereof supports and preferably holds the uterine cervix and utero-cervical fibrotic ring  20  and/or the location vaginal apex. 
         [0093]    Loop  32  at the center of implant  10  may be sutured to uterine cervix  20  and/or to the location vaginal apex and/or naturally adhered after long term attachment, and/or immediately adhered by a biological adhesive, glue, tuckers, sutures, or just placing and depending upon natural adhesion, or any other attachment. 
         [0094]    Each of perpendicular straps  48 A is then extended to the perineal body  26  at the back, for supporting also the posterior compartment of the pelvic floor, the small intestine and the rectum. 
         [0095]    According to one embodiment, loops  34  of straps  48 A are threaded through perineal body  26 . According to another embodiment, loops  34  may be sutured to perineal body  26  and/or naturally adhered by long term attachment, and/or adhered by a biological adhesive. 
         [0096]      FIG. 14  depicts the view of  FIG. 2  after installing the implant of  FIG. 12  on the central and anterior compartments. 
         [0097]    According to this embodiment, implant  10  of  FIG. 12  may also be used for reconstructing the central and the anterior compartment of the pelvic floor, supporting the uterine cervix and utero-cervical fibrotic ring  20  and/or the location vaginal apex, and the urinary bladder. 
         [0098]    Like  FIG. 13 , each of the two ends  86  of mother strap  40  together with the loop  34  thereof is threaded into one sacrospinous ligament  22 . Implant  10  is then adjusted between sacrospinous ligaments  22  such that central loop  32  of implant  10  thereof supports and preferably holds the uterine cervix and utero-cervical fibrotic ring  20  and/or the location vaginal apex. Central loop  32  of implant  10  may be sutured to uterine cervix  20  and/or to the location vaginal apex, and/or naturally adhered by long term attachment, and/or adhered by a biological adhesive. 
         [0099]    Unlike  FIG. 13 , each of extending straps  48 A is then extended to be threaded into one arcus tendineous fascia pelvic (ATFP) ligament  24  and/or the obturator foramen covered with obturator pascia  16  for supporting the anterior compartment of the pelvic floor and the urinary bladder. 
         [0100]      FIG. 15  depicts the installation of  FIG. 14  on the central and anterior compartments, having the additional strap. 
         [0101]    Additional strap  49 A crossing between the perpendicular straps  48 A, for limiting the distance therebetween, may provide further support to the anterior compartment of the pelvic floor and the urinary bladder. 
         [0102]      FIG. 16  illustrates an implant according to another embodiment of the present invention. 
         [0103]    Implant  10  according to this embodiment includes the straps of  FIG. 12 , namely mother strap  40  and additional straps  48 A extending substantially perpendicularly from mother strap  40 . Implant  10  may include additional strap  49 A crossing between the perpendicular straps  48 A. 
         [0104]    Implant  10  of this embodiment may include in addition to implant  10  of  FIG. 12  straps  48 B, which are similar to straps  48 A. An additional strap  49 B may cross between the perpendicular straps  48 B, for limiting the distance therebetween. 
         [0105]      FIG. 17  depicts the view of  FIG. 2  after installing the implant of  FIG. 16  on the central, posterior and anterior compartments. 
         [0106]      FIG. 17  combines  FIGS. 13 and 14 . 
         [0107]    Implant  10  of  FIG. 16  is used for reconstructing the central and the posterior compartment of the pelvic floor, supporting the uterine cervix and utero-cervical fibrotic ring  20  and/or the location vaginal apex, the small intestine and the rectum, and also the anterior compartment of the pelvic floor and the urinary bladder. 
         [0108]    Each of the two ends  86  of the mother strap  40  together with the loop  34  thereof is threaded into one sacrospinous ligament  22 . Implant  10  is then adjusted between sacrospinous ligaments  22  such that central loop  32  of implant  10  thereof supports and preferably holds the central section of the pelvic floor, the uterine cervix and utero-cervical fibrotic ring  20  and/or the location vaginal apex. 
         [0109]    Each of perpendicular straps  48 A is then extended to the perineal body  26  at the back, for also supporting the posterior compartment of the pelvic floor, the small intestine and the rectum. 
         [0110]    Each of extending straps  48 B is then extended to be threaded into one arcus tendineous fascia pelvic (ATFP) ligament  24  and/or the obturator foramen covered with obturator pascia  16  for supporting the anterior compartment of the pelvic floor and the urinary bladder. 
         [0111]      FIG. 18  illustrates an implant according to another embodiment of the present invention. 
         [0112]    Implant  10  according to this embodiment includes the straps of  FIG. 16 , namely mother strap  40  and additional straps  48 A and  48 B, extending substantially perpendicularly from mother strap  40 . Implant  10  may include additional straps  49 A crossing between the perpendicular straps  48 A, and additional strap  49 B crossing between the perpendicular straps  48 B. 
         [0113]    Implant  10  of this embodiment may include in addition to implant  10  of  FIG. 16  also straps  48 C which are similar to straps  48 A. An additional strap  49 C may cross between the perpendicular straps  48 C, for limiting the distance therebetween. 
         [0114]      FIG. 19  depicts the view of  FIG. 2  after installing the implant of  FIG. 18  on the central, posterior and anterior compartments. 
         [0115]    Straps  48 B and  48 C support the anterior compartment. Straps  48 B may be threaded into the arcus tendineous fascia pelvic (ATFP) ligaments  24  close to the obturator foramen covered with obturator pascia  16 , and straps  48 C of  FIG. 18  may be threaded into the arcus tendineous fascia pelvic (ATFP) ligaments  24  close to the iscial spine bone  14 . 
         [0116]    It may be noted that in  FIG. 14  like in  FIG. 19  the anterior compartment may also be supported by two pairs of straps. 
         [0117]    In the figures and/or description herein, the following reference numerals have been mentioned:
       numeral  10  denotes an implant according to one embodiment of the present invention;   numeral  12  denotes the sacrum bone;   numeral  14  denotes the ischial spine bone;   numeral  16  denotes the obturator foramen covered with obturator pascia;   numeral  18  denotes the uterus (womb);   numeral  20  denotes the uterine cervix and utero-cervical fibrotic ring;   numeral  22  denotes a sacrospinous (SS) ligament;   numeral  24  denotes an arcus tendineous fascia pelvic (ATFP) ligament;   numeral  26  denotes the perineal body;   numeral  30  denotes the bony pelvis;   numeral  32  denotes a loop at the center of the central strap;   numeral  34  denotes a loop at the end of any of the straps of the implant;   numeral  40  denotes the central strap of the implant, named mother strap;   numerals  48 A,  48 B and  48 C denote straps extending from the central strap;   numeral  49 A denotes a strap between a pair of  48 A straps;   numeral  49 B denotes a strap between a pair of  48 B straps;   numeral  49 C denotes a strap between a pair of  48 C straps;   numeral  70  denotes a needle;   numeral  72  denotes the body of the needle;   numeral  74  denotes a niche within the needle;   numeral  76  denotes the tip of the needle;   numeral  78  denotes a rod within the needle;   numeral  80  denotes the handle of the needle;   numeral  82  denotes a toggle arm for moving the rod of the needle;   numeral  84  denotes the finger of the surgeon; and   numeral  86  denotes an end of the strap of the implant.       
 
         [0144]    The foregoing description and illustrations of the embodiments of the invention has been presented for the purposes of illustration. It is not intended to be exhaustive or to limit the invention to the above description in any form. 
         [0145]    Any term that has been defined above and used in the claims, should to be interpreted according to this definition. 
         [0146]    The reference numbers in the claims are not a part of the claims, but rather used for facilitating the reading thereof. These reference numbers should not be interpreted as limiting the claims in any form.