Abstract:
In one aspect, the present invention may be directed to a needle for surgical threading of a strap of an implant through a tissue, the needle comprising: a trap for trapping the strap to the needle while the needle may be at the accessible side of the tissue; a tip for threading the trapped strap from the accessible side to the opposing side; and a mechanism for releasing the trap, the mechanism driven from the accessible side of the tissue, thereby allowing return of the tip to the accessible side of the tissue while abandoning the strap at the threaded point, thus performing the threading from the accessible side of the tissue.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The current application claims the benefit of and priority to Israel Patent Application No. 194519, filed Oct. 5, 2008, and incorporated herein by reference in its entirety. 
       FIELD OF THE INVENTION 
       [0002]    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 
       [0003]    Pelvic organ prolapse (POP) is a common female problem that can have a profound impact on a woman&#39;s quality of life. 
         [0004]    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. 
         [0005]    Prolapse surgical reconstruction is performed through the vagina. During the procedure, the surgeon repositions the prolapsed organs, securing them to surrounding tissues and ligaments, and may use a synthetic non-absorbable polypropylene mesh implant. 
         [0006]    However, the prior art surgical procedures penetrate the patient from several directions. 
         [0007]    As well, they do not provide reliable anchoring of the mesh implant. 
         [0008]    It is an object of the present invention to provide a reliable anchoring of the mesh implant. 
         [0009]    Other objects and advantages of the invention will become apparent as the description proceeds. 
       SUMMARY OF THE INVENTION 
       [0010]    The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools methods, and so forth, which are meant to be merely illustrative, not limiting in scope. 
         [0011]    In one aspect, the present invention may be directed to a needle for surgical threading of a strap of an implant through a tissue, the needle comprising:
       a trap for trapping the strap to the needle, while the needle may be at the accessible side of the tissue;   a tip for threading the trapped strap from the accessible side to the opposing side; and   a mechanism for releasing the trap, the mechanism driven from the accessible side of the tissue,   thereby allowing return of the tip to the accessible side of the tissue while abandoning the strap at the threaded point, thus performing threading from the accessible side of the tissue.
 
The trap may comprise:
   a niche, for inserting an end of the strap of the implant; and   a rod, for grasping the end of the strap.
 
The niche may be located near the tip.
       
 
         [0018]    The end of the strap may comprise a looped end for inserting the rod thereinto. 
         [0019]    According to another embodiment the rod is capable of applying physical force on the end of the strap towards the limiting wall thereof in the niche. 
         [0020]    The mechanism for releasing the trap may be manually driven. 
         [0021]    The mechanism for releasing the trap may comprise a cable, driven from the accessible side of the tissue, for removing the rod from the end of the strap. 
         [0022]    The needle may further comprise an arm for driving the mechanism, the arm located outside the surgical area. 
         [0023]    In another aspect, the present invention is directed to an anterior implant comprising:
       at least two first straps for threading thereof into the arcus tendineous fascia pelvic (ATFP) ligaments;   at least two second straps for threading thereof into the sacrospinous (SS) ligaments; and   a loop between the second straps for anchoring thereof to the cervix.       
 
         [0027]    The anterior implant may be used for reconstructing the organs selected from the group including: prolapse of the urinary bladder, the colon, the small intestine. 
         [0028]    The anterior implant may further comprise spaces for reducing weight of the implant. 
         [0029]    In another aspect, the present invention is directed to a posterior implant comprising:
       at least two straps for threading thereof into the sacrospinous (SS) ligaments;   a first loop between the straps for anchoring thereof to the cervix; and   a second loop at the side opposing the straps, the second loop for anchoring thereof to the perineal body.       
 
         [0033]    The posterior implant may be used for reconstructing the organs selected from the group including: the colon, the small intestine, the uterus. 
         [0034]    The posterior implant may further comprise spaces for reducing weight of the implant. 
         [0035]    In another aspect, the present invention is directed to a method for using a needle to thread a strap through a surface, the method comprising the steps of:
       trapping an end of the strap while the needle is at the accessible side of the surface tissue;   threading the needle, together with the trapped strap, through the surface, from the accessible side of the surface;   releasing the trap, such that the driving of release is from the accessible side; and   returning the needle to the accessible side while abandoning the strap at the threaded point,   thereby performing threading from the accessible side.       
 
         [0041]    The trapping of the end of the strap may comprise the steps of:
       inserting the end of the strap into a niche; and   grasping the end of the strap.       
 
         [0044]    Grasping of the end of the strap may comprise the step of inserting a rod of the needle into a looped end of the strap. 
         [0045]    According to another embodiment grasping of the end of the strap may comprise the step of applying physical force on the end of the strap towards the limiting wall thereof in the niche. 
         [0046]    Releasing the trap may comprise the step of removing the rod from the end of the strap. 
         [0047]    In another aspect, the present invention is directed to a method for installing an anterior implant, the method comprising the steps of:
       threading at least two first straps of the implant into the arcus tendineous fascia pelvic (ATFP) ligaments;   threading at least two second straps of the implant into the sacrospinous (SS) ligaments; and   anchoring a loop between the second straps to the cervix.       
 
         [0051]    In another aspect, the present invention is directed to a method for installing a posterior implant, the method comprising the steps of:
       threading at least two straps of the implant into the sacrospinous (SS) ligaments;   anchoring a first loop between the straps, to the cervix; and   anchoring a second loop at the side opposing the straps, to the perineal body.       
 
         [0055]    In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0056]    The objects and features of the present invention will become apparent from the following detailed description considered in conjunction with the accompanying drawings, in which: 
           [0057]      FIG. 1  illustrates an anterior implant according to one embodiment of the present invention. 
           [0058]      FIG. 2  illustrates an anterior view of the pelvic area before installing the anterior implant. 
           [0059]      FIG. 3  illustrates the view of  FIG. 2  after installing the anterior implant. 
           [0060]      FIG. 4  illustrates a posterior implant according to one embodiment of the present invention. 
           [0061]      FIG. 5  illustrates the view of  FIG. 2  after installing the posterior implant. 
           [0062]      FIG. 6  illustrates the head of a needle for threading the straps of the implants, according to one embodiment of the present invention. 
           [0063]      FIG. 7  illustrates the first step of threading the straps of the implants, using the needle of  FIG. 6 . 
           [0064]      FIG. 8  illustrates the second step of threading the straps of the implants, using the needle of  FIG. 6 . 
           [0065]      FIG. 9  illustrates the third step of threading the straps of the implants, using the needle of  FIG. 6 . 
           [0066]      FIG. 10  illustrates the fourth step of threading the straps of the implants, using the needle of  FIG. 6 . 
           [0067]      FIG. 11  illustrates the needle of  FIG. 6  and its operation. 
           [0068]      FIG. 12  illustrates the operation of the needle of  FIG. 6  from the aspect of the surgeon&#39;s access to the pelvic area. 
           [0069]      FIG. 13  illustrates the operation of the needle of  FIG. 6  in the aspect of  FIG. 12 , to another ligament. 
       
    
    
       [0070]    It is to be understood, however, that the drawings are designed solely for purposes of illustration and not as a definition of the limits of the invention, for which reference should be made to the appended claims. It should be further understood that the drawings are not necessarily drawn to scale and that, unless otherwise indicated, are merely intended to conceptually illustrate the structures and procedures described herein. Reference numerals may be repeated among the figures in order to indicate corresponding or analogous elements. 
       DETAILED DESCRIPTION OF THE INVENTION 
       [0071]    In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In some instances, well-known methods, procedures, components and circuits have not been described in detail, for the sake of brevity. 
         [0072]      FIG. 1  illustrates an anterior implant according to one embodiment of the present invention. 
         [0073]    Anterior implant  1  includes four straps  10 , each ending with a looped end  20 . Anterior implant  1  may also include a loop  8  between two interior straps  10 . 
         [0074]    Anterior implant  1  may include spaces  4  for reducing the weight thereof. 
         [0075]      FIG. 2  illustrates an anterior view of the pelvic area before installing the anterior implant. 
         [0076]    The anterior view of pelvic area  34  refers to the side allowing surgical access through the patient&#39;s vaginal opening. 
         [0077]    Denoted bones are the ischial spine  27  extending from the posterior border of the ischium  26 , and the sacrum  46 . 
         [0078]    Also shown are the perineal body  52 , and the cervix  50  extending from the uterus (womb)  48 . 
         [0079]    Pelvic area  34  includes two ligaments of arcus tendineous fascia pelvic (ATFP)  30  and two ligaments of sacrospinous (SS)  28 . 
         [0080]      FIG. 3  illustrates the view of  FIG. 2  after installing the anterior implant. 
         [0081]    Anterior implant  1  is used for reconstructing the anterior pelvic floor, including prolapse of the urinary bladder and/or the colon and the small intestine. 
         [0082]    Two straps  10  of anterior implant  1  are threaded into two ATFP ligaments  30 , and the other two straps  10  are inserted into two SS ligaments  28 . 
         [0083]    Loop  8  may be sutured to cervix  50  for improving strength and security of the anchoring of anterior implant  1 . 
         [0084]      FIG. 4  illustrates a posterior implant according to one embodiment of the present invention. 
         [0085]    Posterior implant  2  includes two straps  10 , each ending with a looped end  20 . Posterior implant  2  may include a loop  36  between two interior straps  10 , and another loop  9  at the opposing side. 
         [0086]    Posterior implant  2  may include spaces  4  for reducing the weight thereof. 
         [0087]      FIG. 5  illustrates the view of  FIG. 2  after installing the posterior implant. 
         [0088]    Posterior implant  2  is used for reconstructing the posterior pelvic floor, including prolapse of the colon, the small intestine and/or the uterus (womb). 
         [0089]    Two straps  10  of posterior implant  2  are inserted into two SS ligaments  28 . 
         [0090]    Loop  36  may be sutured to cervix  50 , and loop  9  may be sutured to perineal body  52  for improving the strength and security of the connection. 
         [0091]      FIG. 6  illustrates the head of a needle for threading the straps of the implants, according to one embodiment of the present invention. 
         [0092]    A needle  6  is used for threading each of straps  10  through ATFP ligaments  30  and SS ligaments  28 . 
         [0093]    The head of needle  6  includes a rod  18 , which may be manually slid back and forth in a track  16  within a body  14 , as in brake cables. 
         [0094]    The edge  42  of rod  18  may be inserted into a niche  40 . The tip  12  of needle  6  is located at the edge of body  14 . 
         [0095]      FIG. 7  illustrates the first step of threading the straps of the implants, using the needle of  FIG. 6 . 
         [0096]    The surgeon inserts looped end  20  of strap  10  into niche  40 , and traps it by rod edge  42  of rod  18  into looped end  20 . 
         [0097]    In case that the surgeon has not succeeded in inserting rod  18  into looped end  20 , the surgeon may trap looped end  20  by applying physical force of rod edge  42  towards the limiting wall thereof in niche  40 . 
         [0098]    According to another embodiment the surgeon may trap strap  10  directly by applying physical force of rod edge  42  on the end of strap  10  towards the limiting wall thereof in niche  40 . 
         [0099]      FIG. 8  illustrates the second step of threading the straps of the implants, using the needle of  FIG. 6 . 
         [0100]    The surgeon then pushes tip  12  together with body  14  into an ATFP ligament  30  or into an SS ligament  28 , threading looped end  20  and strap  10  through the ligament. 
         [0101]      FIG. 9  illustrates the third step of threading the straps of the implants, using the needle of  FIG. 6 . 
         [0102]    The surgeon then slides rod edge  42  out of niche  40 , releasing looped end  20  from rod edge  42 . 
         [0103]      FIG. 10  illustrates the fourth step of threading the straps of the implants, using the needle of  FIG. 6 . 
         [0104]    The surgeon then pulls body  14  together with tip  12  out of ATFP ligament  30  or SS ligament  28 . Since looped end  20  has been released at the third step, and since ligament  30  (or  28 ) shrinks tightly, as shown by the arrows, strap  10  remains threaded while tip  12  exits. 
         [0105]      FIG. 11  illustrates the needle of  FIG. 6  and its operation. 
         [0106]    The surgeon holds handle  24  of needle  6 , and slides rod  18  by toggling a toggle arm  22 , which is connected to rod  18 . 
         [0107]    Needle  6  as a whole may be flexible like a brake cable, thin and long enough to occupy minimal surgery space. 
         [0108]    Since tip  12  is inserted into the pelvic area, and toggle arm  22  is far away tip  12 , toggle arm is located outside the body of the patient and may be located farther and outside the surgical area. 
         [0109]    It may be appreciated according to these steps that the surgeon can thread strap  10  from the side having surgical access, without requiring any additional perforations of the body from the opposing direction. 
         [0110]      FIG. 12  illustrates the operation of the needle of  FIG. 6  in aspect of the surgeon&#39;s access to the pelvic area. 
         [0111]    The surgeon inserts finger  32  thereof into the vagina  44  between the patient&#39;s legs  38  and reaches pelvic area  34  (the lines of the parts inside are dashed). The surgeon then separates an SS ligament  28  from the other organs, locates tip  12  of needle  6  on a selected threading point on SS ligament  28 , and traps trapping looped end  20  to niche  40  of needle  6 . 
         [0112]    The surgeon then penetrates tip  12  through SS ligament  28  and pushes into the desired depth; then releases looped end  20  from needle  6  by toggling toggle arm  22 , using the other hand thereof. 
         [0113]    The surgeon can then pull tip  12  back, leaving looped end  20  and strap  10  at the side beyond, having tight shrinking of SS ligament  28  towards strap  10  at the threaded point. 
         [0114]    Tying of strap  10  is not required due to natural tying of SS ligament  28  to strap  10 . 
         [0115]      FIG. 13  illustrates the operation of the needle of  FIG. 6  in aspect  FIG. 12 , to another ligament. 
         [0116]    The surgeon inserts the finger  32  thereof into vagina  44 , then separates an ATFP ligament  30 , and locates tip  12  of needle  6  on the selected threading point, after trapping looped end  20  to niche  40  of needle  6 . 
         [0117]    The surgeon then penetrates tip  12  through ATFP ligament  30  and on to the desired depth; then releases looped end  20  from needle  6  by toggling toggle arm  22 , using the other hand thereof, then pulls tip  12  back leaving looped end  20  and strap  10  at the side beyond, having tight shrinking of ATFP ligament  30  towards strap  10  at the threaded point. 
         [0118]    In the figures and description herein, the following numerals and symbols have been mentioned: 
         [0119]    numeral  1  denotes an anterior implant; 
         [0120]    numeral  2  denotes a posterior implant; 
         [0121]    numeral  4  denotes a space for reducing the weight of an implant; 
         [0122]    numeral  6  denotes a needle according to one embodiment of the present invention; 
         [0123]    numeral  8  denotes a loop in the anterior implant for anchoring it to the cervix; 
         [0124]    numeral  9  denotes a loop in the posterior implant for anchoring it to the perineal body; 
         [0125]    numeral  10  denotes a strap extending from the implant; 
         [0126]    numeral  12  denotes a tip of the inventive needle; 
         [0127]    numeral  14  denotes the body of the inventive needle; 
         [0128]    numeral  16  denotes a track within the body of the needle; 
         [0129]    numeral  18  denotes a rod traveling within the body of the needle; 
         [0130]    numeral  20  denotes a looped end at the edge of the implant strap; 
         [0131]    numeral  22  denotes a toggle arm for trapping and releasing the looped end; 
         [0132]    numeral  24  denotes a handle of the needle; 
         [0133]    numeral  26  denotes the ischium (bone); 
         [0134]    numeral  27  denotes the ischial spine (bone); 
         [0135]    numeral  28  denotes a sacrospinous (SS) ligament; 
         [0136]    numeral  30  denotes an arcus tendineous fascia pelvic (ATFP) ligament; 
         [0137]    numeral  32  denotes a surgeon&#39;s finger; 
         [0138]    numeral  34  denotes the pelvic area; 
         [0139]    numeral  36  denotes a loop in the posterior implant for anchoring it to the cervix; 
         [0140]    numeral  38  denotes a patient&#39;s leg; 
         [0141]    numeral  40  denotes a niche in the needle for trapping the looped end of the strap; 
         [0142]    numeral  42  denotes the edge of the rod sliding in the track; 
         [0143]    numeral  44  denotes the vagina, into which the surgeon inserts the finger thereof; 
         [0144]    numeral  46  denotes the sacrum (bone); 
         [0145]    numeral  48  denotes the uterus (womb); 
         [0146]    numeral  50  denotes the cervix, extending from the uterus; and 
         [0147]    numeral  52  denotes the perineal body; 
         [0148]    While certain features of the invention have been illustrated and described herein, the invention can be embodied in other forms, ways, modifications, substitutions, canchores, equivalents, and so forth. The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of this disclosure. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.